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Cited by 626Blood transfusion and managementTrauma, Hemostasis, Coagulopathy, ResuscitationCardiac and Coronary Surgery Techniques

Point-of-Care Testing: A Prospective, Randomized Clinical Trial of Efficacy in Coagulopathic Cardiac Surgery Patients

Open access
Weber, Christian Friedrich, Görlinger, Klaus, Meininger, Dirk, Herrmann, Eva, Bingold, Tobias, Moritz, Anton, Cohn, Lawrence H., Zacharowski, Kai·2012·Anesthesiology
DOI 10.1097/aln.0b013e318264c644
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Abstract

Introduction: The current investigation aimed to study the efficacy of hemostatic therapy guided either by conventional coagulation analyses or point-of-care (POC) testing in coagulopathic cardiac surgery patients. Methods: Patients undergoing complex cardiac surgery were assessed for eligibility. Those patients in whom diffuse bleeding was diagnosed after heparin reversal or increased blood loss during the first 24 postoperative hours were enrolled and randomized to the conventional or POC group. Thromboelastometry and whole blood impedance aggregometry have been performed in the POC group. The primary outcome variable was the number of transfused units of packed erythrocytes during the first 24 h after inclusion. Secondary outcome variables included postoperative blood loss, use and costs of hemostatic therapy, and clinical outcome parameters. Sample size analysis revealed a sample size of at least 100 patients per group. Results: There were 152 patients who were screened for eligibility and 100 patients were enrolled in the study. After randomization of 50 patients to each group, a planned interim analysis revealed a significant difference in erythrocyte transfusion rate in the conventional compared with the POC group [5 (4;9) versus 3 (2;6) units [median (25 and 75 percentile)], P<0.001]. The study was terminated early. The secondary outcome parameters of fresh frozen plasma and platelet transfusion rates, postoperative mechanical ventilation time, length of intensive care unit stay, composite adverse events rate, costs of hemostatic therapy, and 6-month mortality were lower in the POC group. Conclusions: Hemostatic therapy based on POC testing reduced patient exposure to allogenic blood products and provided significant benefits with respect to clinical outcomes.

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Crossref · 10.1097/aln.0b013e318264c644

Cites

43 of 43 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

13 of 47 cited sources checked · 4 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Algorithm-based hemostatic therapy is superior to empiric hemostatic therapy based on clinical judgment.

    “In this context, algorithm-based hemostatic therapy has been shown to be superior to empiric hemostatic therapy that is based on clinical judgment.5”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [5] 5. Avidan MS, Alcock EL, Da Fonseca J, Ponte J, Desai JB, Despotis GJ, Hunt BJ: Comparison of structured use of rou- tine laboratory tests or near-patient assessment with clinical judgement in the management of bleeding after cardiac sur- gery. Br J Anaesth 2004; 92:178 -86 source

      The Abstract and Discussion report that algorithm-guided management after routine cardiac surgery reduced transfusions compared with clinician discretion. They also report similar blood loss across groups, so the unqualified claim of superior hemostatic therapy is broader than the demonstrated benefit. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • Premisecitation

    Standard laboratory coagulation tests usually have a long turnaround time of at least 30-45 minutes.

    “Furthermore, in most cases, they have a long turnaround time of at least 30 -45 min.[33][34][35]”
    Quote in the paperSubstantial claim1 of 3 sources checked
    • cites [33] 33. Toulon P, Ozier Y, Ankri A, Fleron MH, Leroux G, Samama CM: Point-of-care versus central laboratory coagulation test- ing during haemorrhagic surgery. A multicenter study. Thromb Haemost 2009; 101:394 -401

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [34] 34. Haas T, Spielmann N, Mauch J, Madjdpour C, Speer O, Schmugge M, Weiss M: Comparison of thromboelastometry (ROTEM) with standard plasmatic coagulation testing in paediatric surgery. Br J Anaesth 2012; 108:36 -41 source
    • cites [35] 35. Dirkmann D, Go ¨rlinger K, Dusse F, Kottenberg E, Peters J: Early clot firmness accurately predicts maximum clot firm- ness in thromboelastometry during cardiac surgery. Eur J Anaesthesiol 2010; 27:105-6 source
  • Premisecitation

    The inappropriateness of blood transfusion did not change dramatically over the past 20 years.

    “This issue of inappropriateness of blood transfusion did not dramatically change during the past 20 yr.[27][28][29]”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [27] 27. Snyder-Ramos SA, Mo ¨hnle P, Weng YS, Bo ¨ttiger BW, Kulier A, Levin J, Mangano DT; Investigators of the Multicenter Study of Perioperative Ischemia; MCSPI Research Group: The ongoing variability in blood transfusion practices in cardiac surgery. Transfusion 2008; 48:1284 -99

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [28] 28. Shander A, Fink A, Javidroozi M, Erhard J, Farmer SL, Corwin H, Goodnough LT, Hofmann A, Isbister J, Ozawa S, Spahn DR; International Consensus Conference on Transfusion Out- comes Group: Appropriateness of allogeneic red blood cell transfusion: The international consensus conference on transfusion outcomes. Transfus Med Rev 2011;25: 232- 46.e53 source
    • cites [29] 29. Stanworth SJ, Grant-Casey J, Lowe D, Laffan M, New H, Murphy MF, Allard S: The use of fresh-frozen plasma in England: High levels of inappropriate use in adults and chil- dren. Transfusion 2011; 51:62-70 source

      The Discussion reports that many patients were continuing to receive fresh-frozen plasma unnecessarily. It does not compare inappropriate use across the past 20 years, and its findings concern fresh-frozen plasma rather than blood transfusion generally. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
  • Premisecitation

    A10 values in ROTEM tests reliably predict maximum clot firmness.

    “A10 values in ROTEM tests have been shown to reliably predict maximum clot firmness.36”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [36] 36. Venema LF, Post WJ, Hendriks HG, Huet RC, de Wolf JT, de Vries AJ: An assessment of clinical interchangeability of TEG and RoTEM thromboelastographic variables in cardiac surgi- cal patients. Anesth Analg 2010; 111:39 -44 source

      The retrieved passages are bibliographic metadata rather than findings about clot measurements (indexed section labeled Abstract, no page). Searches for A10, ten-minute clot amplitude, and prediction of maximum clot firmness found no passage addressing the claim in our copy. (LLM, conf=0.72)

      Experimental — accuracy not yet measured
  • Premisecitation

    Two prospective observational studies reported median turnaround times for central-laboratory conventional coagulation tests of 88 minutes (range 29-235) and 53 minutes (IQR 45-63).

    “Two recently published prospective observational studies reported a median turnaround time for conventional coagulation tests, performed in the central laboratory, of 88 min (range: 29 -235 min) and 53 min (interquartile range: 45-63 min), respectively.34,35”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [34] 34. Haas T, Spielmann N, Mauch J, Madjdpour C, Speer O, Schmugge M, Weiss M: Comparison of thromboelastometry (ROTEM) with standard plasmatic coagulation testing in paediatric surgery. Br J Anaesth 2012; 108:36 -41 source
    • cites [35] 35. Dirkmann D, Go ¨rlinger K, Dusse F, Kottenberg E, Peters J: Early clot firmness accurately predicts maximum clot firm- ness in thromboelastometry during cardiac surgery. Eur J Anaesthesiol 2010; 27:105-6 source
  • May combine two claims. 24
  • Classified as probably not a substantial claim. 12

  • May combine two claims.

    Premisecitation

    Evidence from viscoelastic studies suggests that incorporating point-of-care measurements into hemostatic therapy algorithms may reduce allogenic blood product transfusion and improve clinical outcomes.

    “There is some evidence from studies using viscoelastic analyses of clot formation and dissolution that the implementation of point-of-care (POC) measurements in hemostatic therapy algorithms may reduce the transfusion rate of allogenic blood products and positively influence clinical outcomes.6 -10”
    Quote in the paperSubstantial claim2 of 5 sources checked
    • cites [6] 6. Shore-Lesserson L, Manspeizer HE, DePerio M, Francis S, Vela-Cantos F, Ergin MA: Thromboelastography-guided trans- fusion algorithm reduces transfusions in complex cardiac surgery. Anesth Analg 1999; 88:312-9 source
    • cites [7] 7. Nuttall GA, Oliver WC, Santrach PJ, Bryant S, Dearani JA, Schaff HV, Ereth MH: Efficacy of a simple intraoperative transfusion algorithm for nonerythrocyte component utiliza- tion after cardiopulmonary bypass. ANESTHESIOLOGY 2001; 94: 773-81; discussion 5A-6A source
    • cites [8] 8. Ak K, Isbir CS, Tetik S, Atalan N, Tekeli A, Aljodi M, Civelek A, Arsan S: Thromboelastography-based transfusion algo- rithm reduces blood product use after elective CABG: A prospective randomized study. J Card Surg 2009; 24:404 -10 source
    • cites [9] 9. Westbrook AJ, Olsen J, Bailey M, Bates J, Scully M, Salamon- sen RF: Protocol based on thromboelastograph (TEG) out- performs physician preference using laboratory coagulation tests to guide blood replacement during and after cardiac surgery: A pilot study. Heart Lung Circ 2009; 18:277-88 source
    • cites [10] 10. Girdauskas E, Kempfert J, Kuntze T, Borger MA, Enders J, Fassl J, Falk V, Mohr FW: Thromboelastometrically guided transfusion protocol during aortic surgery with circulatory arrest: A prospective, randomized trial. J Thorac Cardiovasc Surg 2010; 140:1117-24.e2 source

      The Results report fewer cumulative allogeneic blood units with the ROTEM-guided algorithm (9.0 versus 16.0 units; P = .02). They also state that clinical outcomes, including ICU stay, hospital stay, and in-hospital mortality, were similar between groups. The source therefore supports reduced transfusion but not improved clinical outcomes. Page numbers were not available in our copy. (LLM, conf=0.90)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    A prior retrospective analysis of 1,188 cardiac surgery patients with cardiopulmonary bypass found that postoperative hemorrhage was independently associated with worse clinical outcomes, higher 30-day mortality (5.5% vs. 22.4% for nonbleeding vs. bleeding patients), and increased hospital costs.

    “in another recently published retrospective analysis including 1,188 patients undergoing cardiac surgery with CPB, postoperative hemorrhage was independently associated with worse clinical outcomes, increased 30-day mortality (5.5% vs. 22.4% in the nonbleeding and bleeding patients, respectively), and hospital costs.21,22”
    Quote in the paperNot a substantial claim2 of 2 sources checked
    • cites [21] 21. Christensen MC, Krapf S, Kempel A, von Heymann C: Costs of excessive postoperative hemorrhage in cardiac surgery. J Thorac Cardiovasc Surg 2009; 138:687-93 source

      Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured
    • cites [22] 22. Christensen MC, Dziewior F, Kempel A, von Heymann C: Increased chest tube drainage is independently associated with adverse outcome after cardiac surgery. J Cardiothorac Vasc Anesth 2012; 26:46 -51 source

      Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    The mean number of units transfused in the conventional group was comparable to data from Hardy et al. (reference 25).

    “(which is comparable with data obtained by Hardy et al. 25 )”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [25] 25. Hardy JF, Perrault J, Tremblay N, Robitaille D, Blain R, Car- rier M: The stratification of cardiac surgical procedures ac- cording to use of blood products: A retrospective analysis of 1480 cases. Can J Anaesth 1991; 38:511-7 source

  • May combine two claims.

    Interpretationcitation

    This may enable more specific goal-directed interventions to reduce both transfusion requirements and thromboembolic complications.

    “This may allow for more specific goal-directed interventions to reduce both transfusion requirements and thromboembolic complications.20,46”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [20] 20. Go ¨rlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J: First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery. A retrospective, single-center cohort study. ANESTHESIOLOGY 2011; 115: 1179 -91

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [46] 46. Despotis G, Avidan M, Eby C: Prediction and management of bleeding in cardiac surgery. J Thromb Haemost 2009; 7:111-7 source

      In “Clinical utility of point-of-care tests and transfusion algorithms” (page unavailable), the review reports that test-guided transfusion algorithms reduce transfusion requirements and help select therapy for clinical bleeding. It warns that unwarranted prophylactic treatment may cause thrombotic complications, but does not show that goal-directed interventions reduce thromboembolic complications. (LLM, conf=0.83)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisereasoning

    POC tests can detect tissue factor expression on circulating cells, fibrin polymerization disorders (e.g., from colloid infusion), hyperfibrinolysis, and platelet dysfunction due to cardiopulmonary bypass or antiplatelet drugs.

    “Therefore, they are able to detect tissue factor expression on circulating cells, fibrin polymerization disorders, e.g., due to colloid infusion, hyperfibrinolysis, as well as platelet dysfunction due to CPB or antiplatelet drugs.38 -44”
    Quote in the paperSubstantial claim1 of 7 sources checked
    • cites [38] 38. Zacharowski K, Sucker C, Zacharowski P, Hartmann M: Thrombelastography for the monitoring of lipopolysaccha- ride induced activation of coagulation. Thromb Haemost 2006; 95:557-61 source
    • cites [39] 39. Reinho ¨fer M, Brauer M, Franke U, Barz D, Marx G, Lo ¨sche W: The value of rotation thromboelastometry to monitor dis- turbed perioperative haemostasis and bleeding risk in pa- tients with cardiopulmonary bypass. Blood Coagul Fibrino- lysis 2008; 19:212-9

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [40] 40. Bolliger D, Go ¨rlinger K, Tanaka KA: Pathophysiology and treatment of coagulopathy in massive hemorrhage and he- modilution. ANESTHESIOLOGY 2010; 113:1205-19 source
    • cites [41] 41. Fenger-Eriksen C, Moore GW, Rangarajan S, Ingerslev J, Sø- rensen B: Fibrinogen estimates are influenced by methods of measurement and hemodilution with colloid plasma expand- ers. Transfusion 2010; 50:2571-6 source
    • cites [42] 42. Larsen OH, Fenger-Eriksen C, Christiansen K, Ingerslev J, Sørensen B: Diagnostic performance and therapeutic conse- quence of thromboelastometry activated by kaolin versus a panel of specific reagents. ANESTHESIOLOGY 2011; 115:294 - 302 source

      The Discussion (page unavailable) says FIBTEM identified dilutional coagulopathy and links colloid administration to abnormal fibrinogen polymerization. The diagnostic results (page unavailable) also report detection of modeled hyperfibrinolysis. The paper does not establish detection of tissue-factor expression on circulating cells or platelet dysfunction caused by cardiopulmonary bypass or antiplatelet drugs; its platelet model was thrombocytopenia. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [43] 43. Rahe-Meyer N, Winterhalter M, Boden A, Froemke C, Piepen- brock S, Calatzis A, Solomon C: Platelet concentrates trans- fusion in cardiac surgery and platelet function assessment by multiple electrode aggregometry. Acta Anaesthesiol Scand 2009; 53:168 -75 source
    • cites [44] 44. Ferreiro JL, Sibbing D, Angiolillo DJ: Platelet function testing and risk of bleeding complications. Thromb Haemost 2010; 103:1128 -35 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The reduction in mortality observed in this study was larger than the authors had expected.

    “the dimension of the observed reduction in mortality exceeded our expectations.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In univariate logistic regression, group allocation and CPB time were significant predictors of 6-month mortality, whereas redo surgery was not.

    “In univariate log regression, performed to assess whether the known potential risk factors CPB time and redo surgery might have had an effect on mortality in our study in addition to group allocation, only group allocation (P ϭ 0.014) and CPB time (P ϭ 0.001) were significant predictors of mortality, whereas redo surgery was not (P ϭ 0.07).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    POC-group patients had lower exposure to fresh frozen plasma and platelet concentrate during the study period, and they received equal or lower dosages of coagulation factor concentrates (lower for rFVIIa).

    “Patients in the POC group had a lower exposure to FFP and PC during the study period, and they received equal (or, with respect to rFVIIa, lower) dosages of coagulation factor concentrates.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The conventional group had higher intraoperative and postoperative blood loss, but there were no group differences in hemoglobin concentration.

    “Although patients in the conventional group had higher intraoperative and postoperative blood loss, we detected no group differences in the hemoglobin concentration.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In univariate log regression and subsequent multivariate analysis, both group allocation and CPB time were independent significant predictors of mortality.

    “in univariate log regression and subsequent multivariate analysis, both group allocation and CPB time have been shown to be independent significant predictors of mortality.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    CPB time approached statistical significance, with a slight but nonsignificant favor toward shorter CPB times in the POC group (P = 0.104; 95% CI for the difference in mean CPB times, −39 to 4 minutes).

    “only CPB time approaches statistical significance with a slight but nonsignificant favor (P ϭ 0.104) to shorter CPB times for the POC group (95% CI for the difference of mean CPB times is Ϫ39 to 4 min).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The reduction in composite adverse events and 6-month mortality in the POC group achieved statistical significance.

    “although the reduction in the incidence of composite adverse events and 6-month mortality achieved statistical significance in the POC group.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    A planned interim analysis after 50% enrollment (n=100) used a stopping threshold of P<0.01 for group differences in packed erythrocyte transfusion.

    “An interim analysis of the primary outcome variable was planned after inclusion of 50% (n ϭ 100) of the study population.The study was planned to be terminated early if group differences in the number of transfused packed erythrocytes exceeded a level of significance defined as P Ͻ 0.01.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    The cost analysis did not include acquisition costs of POC devices, costs for disposables in the central laboratory, or labor costs for technicians.

    “The costs analyses did not include the acquisition costs of the POC devices, the costs for disposables in the central laboratory and labor costs for the technicians in the central laboratory.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductcitation

    The study did not analyze transfusion requirements for the entire hospital stay, which minimized survival bias.

    “Furthermore, we did not analyze the transfusion requirements during the entire hospital stay so that survival bias was minimized.23,24”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [23] 23. Snyder CW, Weinberg JA, McGwin G Jr, Melton SM, George RL, Reiff DA, Cross JM, Hubbard-Brown J, Rue LW 3rd, Kerby JD: The relationship of blood product ratio to mortality: Survival benefit or survival bias? J Trauma 2009; 66:358 -62; discussion 362-4 source
    • cites [24] 24. Ho AM, Dion PW, Yeung JH, Holcomb JB, Critchley LA, Ng CS, Karmakar MK, Cheung CW, Rainer TH: Prevalence of survivor bias in observational studies on fresh frozen plasma: Erythrocyte ratios in trauma requiring massive transfusion. ANESTHESIOLOGY 2012; 116:716 -28

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Study design and conductown data

    100 patients were randomized, 50 to each group, and there were no losses or exclusions after randomization.

    “a total of 100 patients were randomized: 50 to the conventional group and 50 to the POC group.”
    • Also stated in: § Results · plain
      “There were no losses or exclusions following randomization.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    Hemostatic therapy algorithms based on POC testing reduced perioperative exposure to allogenic blood products and improved clinical outcomes compared with conventional laboratory-based algorithms.

    “Hemostatic therapy based on POC testing reduced patient exposure to allogenic blood products and provided significant benefits with respect to clinical outcomes.”
    • Also stated in: § Discussion · plain
      “The primary study results showed that the use of hemostatic therapy algorithms based on POC testing was associated with (1) reduced perioperative exposure to allogenic blood products and (2) improved clinical outcome.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The clinical criteria used for enrollment (diffuse bleeding from capillary beds or blood loss exceeding 250 ml/h or 50 ml/10 min) identify patients with coagulopathy requiring hemostatic therapy.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Standard quality control procedures were routinely performed for each device according to manufacturer recommendations.

    “Standard quality control procedures for each device were routinely performed following the manufacturer's recommendations.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Adjustments for multiple comparisons were performed only for PaO2/FiO2 indices and postoperative chest tube blood loss.

    “As a conservative choice, adjustments for multiple comparisons were only performed for PaO 2 /FiO 2 indices and postoperative chest tube blood loss.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    There were no group differences in baseline demographics, clinical characteristics, or laboratory characteristics.

    “There were no group differences regarding baseline demographics or clinical or laboratory characteristics (table 1).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Randomization used a computer-generated balanced blockwise list (allocation ratio 1:1, block size 20*10) produced by BiAS software.

    “The ran-domization list was computer-generated using a balanced (allocation ratio 1:1) blockwise (20*10) randomization by the software BiAS for Windows 9.07 © (Epsilon Inc., Darmstadt, Germany).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The results of conventional coagulation tests were not used for guiding hemostatic therapy in the POC group.

    “The results of conventional coagulation tests were not used for guiding hemostatic therapy in the POC group.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    All tests were two-sided, and the level of significance was set to P<0.05.

    “All tests were two-sided, and the level of significance was set to P Ͻ 0.05.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Reducing patient exposure to allogeneic blood products may reduce transfusion-related complications, may improve clinical outcome, and definitely lowers primary and secondary transfusion costs.

    “However, a reduction in patient exposure to allogenic blood products may minimize the incidence of transfusion-related complications, may beneficially influence clinical outcome, and definitely reduces the primary and secondary costs of transfusions.1,30,31”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [1] 1. Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD: Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation 2007; 116:2544 -52 source
    • cites [30] 30. Kaushal R, Bates DW, Franz C, Soukup JR, Rothschild JM: Costs of adverse events in intensive care units. Crit Care Med 2007; 35:2479 -83 source
    • cites [31] 31. Despotis G, Eby C, Lublin DM: A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion 2008; 48:2S-30S 32. Sniecinski RM, Levy JH: Bleeding and management of coagu- lopathy. J Thorac Cardiovasc Surg 2011; 142:662-7

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    The POC-based algorithm has been used in several German university hospitals since 2007, and its efficacy was described in a retrospective study of 3,865 cardiac surgery patients.

    “The POCbased algorithm has been used in several university hospitals in Germany since 2007 and its efficacy has recently been described in a retrospective study that included 3,865 cardiac surgery patients.19,20”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [19] 19. Go ¨rlinger K, Dirkmann D, Weber CF, Rahe-Meyer N, Hanke AA: Algorithms for transfusion and coagulation management in massive haemorrhage. Ana ¨sth Intensivmed 2011; 52: 145-59

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [20] 20. Go ¨rlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J: First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery. A retrospective, single-center cohort study. ANESTHESIOLOGY 2011; 115: 1179 -91

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Attending physicians in the POC group were blinded to conventional coagulation test results.

    “The attending physicians in the POC group were blinded to the results of conventional coagulation tests.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The trial was registered with ClinicalTrials.gov (NCT00997841).

    “was registered with ClinicalTrials.gov(Identifier: NCT00997841)”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The study was approved by the local ethics committee and complied with the Declaration of Helsinki; all patients gave written informed consent.

    “The current study complies with the declaration of Helsinki, was approved by the local Scientific and Ethics Review Board (Ethics-Committee of the Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany), and was registered with ClinicalTrials.gov(Identifier: NCT00997841).All patients gave written informed consent.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning

    After randomization, coagulation analyses and algorithm-based hemostatic therapy were performed nonblinded, so bias is possible.

    “After patient randomization to the conventional or POC group, coagulation analyses and algorithm-based hemostatic therapy were performed in a nonblinded fashion-thus there is a chance of bias.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    POC-guided therapy was associated with lower fresh frozen plasma and platelet concentrate usage and costs, as well as improved clinical outcome, in this prospective randomized single-center study.

    “Moreover, POC-guided therapy was associated with lower FFP and PC usage and costs as well as an improved clinical outcome in this prospective randomized single-center study.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductcitation

    Both hemostatic therapy algorithms conformed to evidence-based hemostatic therapy management and were comparable in their structural progression of therapy escalation.

    “Both types of hemostatic therapy algorithms conform to evidence-based hemostatic therapy management and were comparable in their structural progression of therapy escalation.9,19,47”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [9] 9. Westbrook AJ, Olsen J, Bailey M, Bates J, Scully M, Salamon- sen RF: Protocol based on thromboelastograph (TEG) out- performs physician preference using laboratory coagulation tests to guide blood replacement during and after cardiac surgery: A pilot study. Heart Lung Circ 2009; 18:277-88 source
    • cites [19] 19. Go ¨rlinger K, Dirkmann D, Weber CF, Rahe-Meyer N, Hanke AA: Algorithms for transfusion and coagulation management in massive haemorrhage. Ana ¨sth Intensivmed 2011; 52: 145-59

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [47]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In the study by Haas et al., ROTEM analysis was performed in the central laboratory and transmitted online to a screen in the operating room.

    “In this study published by Haas et al., 35 ROTEM analysis was performed in the central laboratory and submitted online to a screen in the operation room.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [35] 35. Dirkmann D, Go ¨rlinger K, Dusse F, Kottenberg E, Peters J: Early clot firmness accurately predicts maximum clot firm- ness in thromboelastometry during cardiac surgery. Eur J Anaesthesiol 2010; 27:105-6 source

  • May combine two claims.

    Study design and conductown data

    The clinical applicability of both algorithms can be assumed because all patients had hemostatic testing before therapy and none received therapy that deviated from the allocated algorithm.

    “The clinical applicability of both algorithms can be assumed because all patients had hemostatic testing before therapy and none of them received therapy that deviated from the allocated algorithm.”
    Quote in the paperSubstantial claim
33 of 33

  • The paper relies on this without support.

    The clinical criteria used for enrollment (diffuse bleeding from capillary beds or blood loss exceeding 250 ml/h or 50 ml/10 min) identify patients with coagulopathy requiring hemostatic therapy.

    “Patients were enrolled in the study after heparin reversal following CPB if at least one of the two inclusion criteria were fulfilled: (1) diffuse bleeding from capillary beds at wound surfaces requiring hemostatic therapy as assessed by the anesthesiologist and surgeon by inspecting the operative field and/or (2) intraoperative or postoperative (during the first 24 postoperative hours) blood loss”

  • The paper relies on this without support.

    The amount of transfused packed erythrocytes is a reliable surrogate parameter for the efficacy of hemostatic therapy.

    “Because the amount of transfused packed erythrocytes represents a reliable surrogate parameter for the efficacy of hemostatic therapy, it was defined as the primary outcome variable of the current study.”

  • The paper relies on this without support.

    Bleeding and the consecutive need for transfusion of packed erythrocytes in the intraoperative period and the first 24 h after surgery reflect the surgery-associated coagulopathy and the potential effects of different hemostatic strategies.

    “Bleeding and the consecutive need for transfusion of packed erythrocytes in the intraoperative period and the first 24 h after surgery most likely reflect the surgery-associated coagulopathy and thus the potential effects of different hemostatic strategies.”
3 of 3

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Median transfusion counts are called means

    Minor

    The discussion calls 5 and 3 the mean numbers of units transfused, but the results identify those same values and their accompanying percentiles as medians.

1 of 1

Cites

Flagged first, then by citations

Research works printed but not linked: 8

  1. [4]4. Levy JH, Dutton RP, Hemphill JC 3rd, Shander A, Cooper D, Paidas MJ, Kessler CM, Holcomb JB, Lawson JH, Hemostasis Summit Participants: Multidisciplinary approach to the chal- lenge of hemostasis. Anesth Analg 2010; 110:354 -64
  2. [11]11. Luddington RJ: Thrombelastography/thromboelastometry. Clin Lab Haematol 2005; 27:81-90
  3. [15]15. The Board of the German Medical Association on the Rec- ommendation of the Scientific Advisory Board: Cross-sec- tional guidelines for therapy with blood components and plasma derivatives(4th revised edition). Transfus Med He- mother 2009; 36:351-482
  4. [17]17. Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR, Society of Cardiovascular Anesthesiologists Spe- cial Task Force on Blood Transfusion, Spiess BD, Shore- Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S: Perioperative blood transfusion and blood conservation in cardiac surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiolo- gists clinical practice guideline. Ann Thorac Surg 2007; 83: S27-86
  5. [18]18. Napolitano LM, Kurek S, Luchette FA, Corwin HL, Barie PS, Tisherman SA, Hebert PC, Anderson GL, Bard MR, Bromberg W, Chiu WC, Cipolle MD, Clancy KD, Diebel L, Hoff WS, Hughes KM, Munshi I, Nayduch D, Sandhu R, Yelon JA; American College of Critical Care Medicine of the Society of Critical Care Medicine; Eastern Association for the Surgery of Trauma Practice Management Workgroup: Clinical practice guideline: Red blood cell transfusion in adult trauma and critical care. Crit Care Med 2009;37: 3124 -57
  6. [19]19. Go ¨rlinger K, Dirkmann D, Weber CF, Rahe-Meyer N, Hanke AA: Algorithms for transfusion and coagulation management in massive haemorrhage. Ana ¨sth Intensivmed 2011; 52: 145-59
  7. [27]27. Snyder-Ramos SA, Mo ¨hnle P, Weng YS, Bo ¨ttiger BW, Kulier A, Levin J, Mangano DT; Investigators of the Multicenter Study of Perioperative Ischemia; MCSPI Research Group: The ongoing variability in blood transfusion practices in cardiac surgery. Transfusion 2008; 48:1284 -99
  8. [32]32. Kozek-Langenecker SA: Perioperative coagulation monitor- ing. Best Pract Res Clin Anaesthesiol 2010; 24:27-40

Cited by

Sorted by citations

Related

Authors
Weber, C. F., Görlinger, K., Meininger, D., Herrmann, E., Bingold, T., Moritz, A., Cohn, L. H., & Zacharowski, K.
Affiliations
  • University Hospital Frankfurt (DE)
  • Essen University Hospital (DE)
  • Goethe University Frankfurt (DE)
  • Brigham and Women's Hospital (US)
ORCID
Venue
Anesthesiology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2012-09-01
Volume
117
Issue
3
Pages
531-547
ISSN
0003-3022 (ISSN-L)
DOI
10.1097/aln.0b013e318264c644
OpenAlex
W2033421420
Cited by
625
References
41
Citations by year
2026: 14 · 2025: 23 · 2024: 30 · 2023: 32 · 2022: 25 · 2021: 35 · 2020: 49 · 2019: 53 · 2018: 41 · 2017: 52 · 2016: 64 · 2015: 59 · 2014: 70 · 2013: 65 · 2012: 12
FWCI
46.10
Type
journal article
Language
en
Open access
Locations
  • Anesthesiology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Biochemistry › Blood transfusion and management
  • Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Trauma, Hemostasis, Coagulopathy, Resuscitation
  • Health Sciences › Medicine › Surgery › Cardiac and Coronary Surgery Techniques
Keywords
point-of-care testing, hemostatic therapy, cardiac surgery, coagulopathy, thromboelastometry, impedance aggregometry, red blood cell transfusion, postoperative blood loss, heparin reversal, blood product transfusion, postoperative bleeding
MeSH terms
Aged, Cardiopulmonary Bypass, Female, Fibrinogen, Cardiac Surgical Procedures, Hemostatics, Humans, Male, Middle Aged, Prospective Studies, Factor VIIa, Erythrocyte Transfusion, Point-of-Care Systems

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-02.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-02.

Cited sources are checked by gpt-6-sol.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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