Haemorrhage Alleviation With Tranexamic Acid- Intestinal System (HALT-IT)
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ClinicalTrials.gov Identifier: NCT01658124 |
Recruitment Status :
Completed
First Posted : August 6, 2012
Last Update Posted : April 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Bleeding | Drug: Tranexamic Acid Drug: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12009 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Tranexamic Acid for the Treatment of Gastrointestinal Haemorrhage: an International Randomised, Double Blind Placebo Controlled Trial |
Actual Study Start Date : | July 2013 |
Actual Primary Completion Date : | July 19, 2019 |
Actual Study Completion Date : | July 19, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Tranexamic acid
(total dose 8 grams)
|
Drug: Tranexamic Acid |
Placebo Comparator: Placebo
(Sodium Chloride 0.9%)
|
Drug: Placebo |
- The primary outcome is death from haemorrhage [ Time Frame: within 5 days of randomisation ]
- Death (all cause and cause specific) [ Time Frame: within 28 days of randomisation ]
- Death from haemorrhage [ Time Frame: within 28 days of randomisation ]
- Number of Patients with Re-bleeding [ Time Frame: within 5 and 28 days of randomisation ]
- Number of patients who had Endoscopic, radiological or surgical intervention for gastro intestinal bleeding [ Time Frame: within 28 days of randomisation ]
- Number of patients who had Blood transfusion [ Time Frame: within 28 days of randomisation ]blood or blood component units
- Number of patients with Thromboembolic events [ Time Frame: within 28 days of randomisation ]fatal and non-fatal myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis
- Number of patients with Other adverse medical events [ Time Frame: within 28 days of randomisation ]including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure, other reported events
- Functional status measured using the Katz Index of Independence in Activities of Daily Living [ Time Frame: within 28 days of randomisation ]
- Time spent at an intensive care or high dependency unit [ Time Frame: within 28 days of randomisation ]
- Length of stay in hospital [ Time Frame: within 28 days of randomisation ]
- Patient status (death, hospital readmission) [ Time Frame: within 12 months of randomisation ]Limited to recruiting countries with appropriate databases

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients
- with acute significant upper or lower gastrointestinal bleeding
- where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient
Exclusion Criteria:
- The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular patient with upper or lower gastrointestinal bleeding.
- There are no other exclusions.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658124
United Kingdom | |
Over 50 countries Worldwide | |
London, United Kingdom |
Study Director: | Haleema Shakur-Still | LSHTM |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT01658124 |
Other Study ID Numbers: |
ISRCTN11225767 |
First Posted: | August 6, 2012 Key Record Dates |
Last Update Posted: | April 17, 2020 |
Last Verified: | February 2020 |
haemorrhage,antifibrinolytic, clinical trial, |
Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Gastrointestinal Diseases Digestive System Diseases Tranexamic Acid |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |