drugset / Trial / NCT01658124
Haemorrhage Alleviation With Tranexamic Acid- Intestinal System
Phase 3
Completed
12009 enrolled
London School of Hygiene and Tropical Medicine
Rawalpindi Medical College · collabUniversity of Ibadan · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Severe bleeding in the digestive system is a common symptom of many diseases. Each year, about 50,000 people end up in British hospitals because of this problem and about 5,000 of them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa, schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach bleeding each year. From previous research in other bleeding conditions such as surgery and trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are any complications in people with severe bleeding from the digestive system.
Timeline
- Start
- 2013-07
- Primary completion
- 2019-07-19
- Completion
- 2019-07-19
Publications
- Roberts I, Shakur-Still H, Afolabi A, Akere A, Arribas M, Austin E, Bal K, Bazeer N, Beaumont D, Brenner A, Carrington L, Chaudhri R, Coats T, Gilmore I, Halligan K, Hussain I, Jairath V, Javaid K, Kayani A, Lisman T, Mansukhani R, Miners A, Mutti M, Nadeem MA, Pollok R, Prowse D, Simmons J, Stanworth S, Veitch A, Williams J. A high-dose 24-hour tranexamic acid infusion for the treatment of significant gastrointestinal bleeding: HALT-IT RCT. Health Technol Assess. 2021 Oct;25(58):1-86. doi: 10.3310/hta25580.
- HALT-IT Trial Collaborators. 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. Lancet. 2020 Jun 20;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.
- Brenner A, Afolabi A, Ahmad SM, Arribas M, Chaudhri R, Coats T, Cuzick J, Gilmore I, Hawkey C, Jairath V, Javaid K, Kayani A, Mutti M, Nadeem MA, Shakur-Still H, Stanworth S, Veitch A, Roberts I; HALT-IT Trial Collaborators. Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial. Trials. 2019 Jul 30;20(1):467. doi: 10.1186/s13063-019-3561-7.
- Roberts I, Coats T, Edwards P, Gilmore I, Jairath V, Ker K, Manno D, Shakur H, Stanworth S, Veitch A. HALT-IT--tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial. Trials. 2014 Nov 19;15:450. doi: 10.1186/1745-6215-15-450.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 3 g | Intravenous |
Indications
No indication recorded.