The DOI matches its Crossref record.
Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial
Open accessAbstract
BACKGROUND: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. FINDINGS: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). INTERPRETATION: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cited by
Enhanced recovery after surgery for major orthopedic surgery: a narrative review
Choi, Y. S., Kim, T. W., Chang, M. J., Kang, S.-B., & Chang, C. B. (2022) · Knee Surgery & Related Research · doi:10.1186/s43019-022-00137-3 · Cited by 83
Metadata
- Authors
- Roberts, I., Shakur-Still, H., Afolabi, A., Akere, A., Arribas, M., Brenner, A., Chaudhri, R., Gilmore, I., Halligan, K., Hussain, I., Jairath, V., Javaid, K., Kayani, A., Lisman, T., Mansukhani, R., Mutti, M., Arif Nadeem, M., Pollok, R., Simmons, J., Soomro, M., Stanworth, S., Veitch, A., Hawkey, C., Afolabi, A., Cuzick, J., Halligan, K., Henry, D., Metcalfe, C., Roberts, I., Gray, R., Barkun, A., David, S., Devereaux, P., Brady, T., Roberts, I., Shakur-Still, H., Coats, T., Edwards, P., Gilmore, I., Jairath, V., Ker, K., Manno, D., Stanworth, S., Veitch, A., Arribas, M., Austin, E., Bal, K., Balogun, E., Barrow, C., Beaumont, D., Benyahia, M., Brenner, A., Brooks, I., Cargill, M., Carrington, L., Edwards, P., Frimley, L., Geer, A., Gilbert, D., Gilliam, C., Gil Onandia, J., Golfi, N., Hetherington, D., Howe, C., Hughes, C., I'anson, D., Jackson, R., Joshi, M., Kansagra, S., Kawahara, T., Ker, K., Kostrov, S., Manno, D., Mansukhani, R., Miah, H., Ndungu, B., Needham, K., Outtandy, A., Pearson, D., Pepple, T., Prowse, D., Quashi, N., Quinn, A., Ramos, M., Ranopa, L., Reid, M., Roberts, I., Roukas, C., Shakur-Still, H., Squires, C., Tanner, J., Thayne, A., Uddin, R., Chaudhri, R., Mutti, M., Javaid, K., Kayani, A., Fawole, B., Bello, F. A., Olayemi, O., Afolabi, A., Okunade, O., Adetayo, O., Chaudhri, R., Mutti, M., Afolabi, A., Bello, F. A., Fawole, B., Olayemi, O., Khamis, H., Shukri Bin Jahit, M., Gogichaishvili, T., Mateescu, R. B., Adhikaree, A., Abdo, A. E., Zaher, M., Deasy, C., Alvarez Gregori, J., Wellsh, B., Lawton, L., Kamath, R., Barry, A., Carpio, R., Finney, K., Maguire, H., James, M., Coffey, F., Gough, C., Sawers, L., Thi, A.-A., Simmons, J., Burnett, C., Jacques, N., Murray, V., Pollok, R., Jarman, H., Lambe, C., Rounding, S., Tucker, S., Al-Idari, R., Guest, S., Stoddard, E., Yeo, D., Bergin, C., Hardy, E., Thunder, J., Jhalli, P., Hartley, E., Jarvis, C., Swann, C., Reed, M., Gallagher, B., Grahamslaw, J., O'Brien, R., Harris, T., Bellhouse, G., Boulton, O., Skene, I., Stanley, A., Johnstone, J., Maguire, D., Thornton, S., Banks, M., Bercades, G., Marks, D., Ryu, J., Harris, T., Dowty, C., Pott, J., Skene, I., East, J., Bailey, A., Beer, S., Davies, S., Appelboam, A., Mackle, D., Small, J., Vorwerk, C., Atkins, R., Bradbury, I., Coats, T., Bryceland, C., McClelland, L., Thomas, M., Clayton, K., Michael, A., Haig, S., Al-Nahhas, S., Godfrey, T., Boger, P., Comer, R., Watkins, B., Afolabi, O., Afzal, S., Cowton, A., Everett, S., Fazakerley, R., Onoviran, F., Snook, J., Berry, J., Simpson, D., Keep, J., Cotton, H., Helyar, S., Rutter, M., Johnston, T., O'Rourke, L., Chan, L., Tambellini, J., Trodd, D., Shutt, J., Moreton, S., Oglesby, A., Boyle, A., Haeger, N., Hardwick, S., Kendall, J., Faulkner, B., Worner, R., Hearnshaw, S., Doona, M., Price, M., Hunter, L., Bell, M., Loureiro, V., Kehoe, A., Jefferey, A., Squire, R., Hartin, D., Bell, S., Newman, A., Gagg, J., Foot, J., Wakeford, S., May, G., Bartram, T., Cumpstay, P., Parker, L., Das, R., Pahary, S., Wright, G., Butt, G., Christmas, N., Wilson, S., Ashfaq, M., Chandler, L., Al-Nahhas, S., Demetriou, C., Kaye, P., Carley, S., Brown, A., Jones, L., Whileman, A., Greenaway, J., Tregonning, J., Harris, T., Bellhouse, G., Kuhrt, A., Goodacre, S., Jones, J., Owen, C., Mitra, A., Harper-Payne, A., Trudgill, N., Hayes, A., Butt, F., Clifford, G., Kinnon, A., Fowler, S., Pillay, K., Gidwani, S., McNair, A., Omer, O., de Weymarn, T., Amin, A., Chan, L., Martin, J., Mathieu, N., Barnes, S., Turvill, J., Sweeting, H., Draegebo, M., McNaught, M., Grocutt, M., Margalef, J., Humphrey, J., Jackson, R., Bellis, F., Hunt, J., Mitra, A., Stevenson, A., Watson, N., Barden, S., Paterson, S., Veitch, A., Macdonald, C., Hobday, D., Orugun, O., Allison, A., Dyer, T., McBride, S., Sawicki, W., Rayner, B., Flowerdew, L., Barbour, J., Klein, J., Hood, S., Palmer, N., de Wolff, J., Shenoy, A., Trudgill, N., Swallow, P., Srirajaskanthan, R., Hussain, I., Arshad, H., Aslam, N., Bangash, A., Qamar, M., Zahoor, H., Mutti, M., Arshad, S., ain Ghalib, Q., Hameed, T., Saif, T., Shafi, W., Arif Nadeem, M., Ali, A., Khan, S., Muaaz, M., Taj, A., Ghafoor, A., Afridi, A., Ahmad, M., Aslam, M., Kumar, S., Soomro, M., Ali, M., Bughio, U., Chang, A., Shaikh, S., Ahmad, S., Ali, Z., Waqar, M., Mushir, A., Sattar, S., Goraya, S., Aslam, S., Fatima, N., Noreen, S., Saleem, S., Rahman, F., Iqbal, N., Khalid, M., Riaz, U., Umar, M., Akhter, T., Khan, J., Misbah, N., Afzal, M., Kayani, M., Shah, S., Tarar, S., Khan, S., Iqbal, Y., Khan, E., Reki, M., Hussain, T., Iqbal, S., Khurram, M., Shafi, M., Shaikh, A., Ahmed, A., Kumar, A., Sachdev, P., Nasir, K. M., Chaudhry, Z. I., Zubair, M., Tayyab, G., Mushtaq, J., Nasir, M., Khan, A., Ali, A., Ali, S., Uddin, W., Ahmed, S., Kazmi, T., Channa, S., Aman, A., Shaikh, M., Rizvi, T., Hussain, A., Baqai, H. Z., Rasheed, Z., Khan, A., Irfan, A., Husain, A., Aslam, A., Yahya, K., Azhar, S., Ul Haq, M., Afzal, A., Imran, M., Saeed, I., Yusuf, A., Hassan, M., Marwat, M., Ishfaq, M., Bashir, T., Kumar, S., Yaqoob, S., Wahid, A., Akere, A., Fakoya, T., Oke, T., Tejan, E., Olaomi, O., Badejo, O., Nnaemaka, O., Ukwu, N., Arowolo, O., Aderounmu, A., Wuraola, F., Ugiagbe, R., Atiri, A., Eghaghe, E., Adekoya, A., Tade, A. O., Shonoiki, O., Olatoke, S., Raji, T., Ekwunife, C., Onyekpere, C., Ahmed, A., Muhammad, D., Odeghe, E., Lesi, O., Osueni, A., Samaila, A., Nahuche, A., Ajayi, A., Dongo, A., Ijoma, U., Adebanjo, A. T., Igetei, R., Yilkudi, M., Osisanya, K., Okeke, E. N., Enwere, O. O., Esmat, S., Ashoush, O., Naga, M., Nagy, F., Saiid, M., Shaker, A., Khamis, H., Helmy, A., Saafan, S., Abdel Monem, M., Din, J., Azis, K., Brukan, M., Singh, S., Zakaria, A., Farid, S., Hashim, N., Mafauzy, M., Najmi, W., Amri, N., Yi, X., Hisyam, M., Ng, E., Ramli, Z., Yee Lim, S., Voon, K., Young Yam, S., Jahit, M., Joon, L., Melikidze, B., Kazaishvili, D., Gogichaishvili, T., Grubelashvili, N., Mosidze, B., Tomadze, G., Megreladze, A., Oprita, R., Pestroiu Calescu, D., Chioncel, C., Ragea, A., Mateescu, B., Busuioc, B., Voiosu, A., Cotirlet, A., Pintilie, I., Jinga, M., Balaban, D., Tanău, M., Negreanu, L., Bataga, S., Priya, K., Baral, S., K.C., A., Sah, V., Yadav, V., Adhikaree, A., Abdo, A., Ahmed, D., Al Anazi, M., Al Balkhi, A., Deasy, C., Álvarez Gregori, J., Fornieles Pérez, H., Beqiri, A., Wellsh, B., & Lawton, L.
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2020-06
- Volume
- 395
- Issue
- 10241
- Pages
- 1927-1936
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W3036528941
- Cited by
- 404
- References
- 0
- FWCI
- 23.92
- Type
- journal article
- Language
- en
- Open access
- hybrid
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.
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.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
