Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Imberti, Davide; Baldini, Edoardo; Pierfranceschi, Matteo Giorgi; Nicolini, Alberto; Cartelli, Concetto; De Paoli, Marco; Boni, Marcello; Filippucci, Esmeralda; Cariani, Stefano; Bottani, Giorgio

doi:10.1007/s11695-013-1105-x

Cited by 42Venous Thromboembolism Diagnosis and ManagementBariatric Surgery and OutcomesBlood Coagulation and Thrombosis Mechanisms

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Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

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Imberti, Davide, Baldini, Edoardo, Pierfranceschi, Matteo Giorgi, Nicolini, Alberto, Cartelli, Concetto, De Paoli, Marco, Boni, Marcello, Filippucci, Esmeralda, Cariani, Stefano, Bottani, Giorgio·2014·Obesity Surgery

DOI 10.1007/s11695-013-1105-xPMC PMC3885801

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Abstract

BACKGROUND: The optimal dose of low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. The aim of this multicentre, open-label, pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery. METHODS: Patients were randomised to receive 4,250 IU/day (group A) or 6,400 IU/day (group B) of parnaparin s.c. for 7-11 days. Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis, symptomatic pulmonary embolism and death from any cause during treatment. The primary safety endpoint was major and clinically relevant non-major bleeding. RESULTS: A total of 258 patients underwent randomization; 8 subjects were excluded following the safety analysis. One hundred thirty-one patients [106 females; mean age, 40.3 years (standard deviation (SD) ±9.6); mean body mass index (BMI), 44.6 kg/m(2) (SD ±5.4)] were assigned to group A and 119 patients [93 females; mean age, 41.5 years (SD ±9.9); mean BMI, 44.2 kg/m(2) (SD ±5.4)] were assigned to group B. The rate of the primary efficacy outcome was 1.5% (two cases; 95 % confidence interval (CI), 0.2-6.0%) in group A as compared with 0.8% (one case; 95% CI, 0.4-5.3%) in group B (p = ns). The composite incidence of major bleeding and clinically relevant non-major bleeding was 6.1% (eight cases; 95% CI, 2.9-12.1%) in group A and 5.0% (six cases; 95% CI, 2.1-11.1%) in group B (p = ns). CONCLUSIONS: A parnaparin dose of 4,250 IU/day seems suitable for VTE prevention in patients undergoing bariatric surgery.

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There was no evidence on the duration of pharmacological thromboprophylaxis after bariatric surgery.
“Two RCTs were identified reporting on high versus standard dose low-molecular weight heparin after bariatric surgery [62, 63], whereas there was no evidence on the duration of prophylaxis.”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [62]
Two RCTs were identified reporting on high versus standard dose low-molecular weight heparin after bariatric surgery.
“Two RCTs were identified reporting on high versus standard dose low-molecular weight heparin after bariatric surgery [62, 63], whereas there was no evidence on the duration of prophylaxis.”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [62]

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Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP
Di Lorenzo, N., Antoniou, S. A., Batterham, R. L., Busetto, L., Godoroja, D., Iossa, A., Carrano, F. M., Agresta, F., Alarçon, I., Azran, C., et al. (2020) · Surgical Endoscopy · doi:10.1007/s00464-020-07555-y · Cited by 465
The EFFORT trial: Preoperative enoxaparin versus postoperative fondaparinux for thromboprophylaxis in bariatric surgical patients: a randomized double-blind pilot trial
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Authors: Imberti, D., Baldini, E., Pierfranceschi, M. G., Nicolini, A., Cartelli, C., De Paoli, M., Boni, M., Filippucci, E., Cariani, S., & Bottani, G.
Affiliations: Azienda Unità Sanitaria Locale Piacenza (IT)
Ospedaliera di Piacenza (IT)
Santa Maria Nuova Hospital (IT)
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
University of Pavia (IT)
Corresponding author: Imberti, Davide
ORCID: Imberti, Davide
Baldini, Edoardo
Cariani, Stefano
Venue: Obesity Surgery
Publisher: Springer Science and Business Media LLC
Published: 2013-10-27
Volume: 24
Issue: 2
Pages: 284-291
ISSN: 0960-8923 (ISSN-L)
1708-0428
DOI: 10.1007/s11695-013-1105-x
PMC: PMC3885801
OpenAlex: W2077778587
Cited by: 42
References: 40
Citations by year: 2026: 1 · 2025: 1 · 2024: 6 · 2023: 6 · 2022: 3 · 2021: 3 · 2020: 4 · 2019: 5 · 2018: 4 · 2017: 4 · 2015: 4 · 2014: 1
FWCI: 1.46
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
creativecommons.org/licenses/by-nc/2.0 (unspecified)
Locations: Obesity Surgery (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Topics: Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords: thromboprophylaxis, low molecular weight heparin
MeSH terms: Adult, Anticoagulants, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Heparin, Low-Molecular-Weight, Humans, Male, Obesity, Morbid, Pilot Projects, Premedication, Prospective Studies, Treatment Outcome, Bariatric Surgery, Venous Thromboembolism

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Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

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