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Haemorrhage Alleviation With Tranexamic Acid- Intestinal System (HALT-IT)

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ClinicalTrials.gov Identifier: NCT01658124
Recruitment Status : Recruiting
First Posted : August 6, 2012
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
Rawalpindi Medical College
University of Ibadan
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Bleeding Drug: Tranexamic Acid Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid
(total dose 8 grams)
Drug: Tranexamic Acid
Placebo Comparator: Placebo
(Sodium Chloride 0.9%)
Drug: Placebo



Primary Outcome Measures :
  1. The primary outcome is death from haemorrhage [ Time Frame: within 5 days of randomisation ]

Secondary Outcome Measures :
  1. Death (all cause and cause specific) [ Time Frame: within 28 days of randomisation ]
  2. Death from haemorrhage [ Time Frame: within 28 days of randomisation ]
  3. Number of Patients with Re-bleeding [ Time Frame: within 5 and 28 days of randomisation ]
  4. Number of patients who had Endoscopic, radiological or surgical intervention for gastro intestinal bleeding [ Time Frame: within 28 days of randomisation ]
  5. Number of patients who had Blood transfusion [ Time Frame: within 28 days of randomisation ]
    blood or blood component units

  6. 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

  7. 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

  8. Functional status measured using the Katz Index of Independence in Activities of Daily Living [ Time Frame: within 28 days of randomisation ]
  9. Time spent at an intensive care or high dependency unit [ Time Frame: within 28 days of randomisation ]
  10. Length of stay in hospital [ Time Frame: within 28 days of randomisation ]
  11. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Haleema Shakur-Still ++44(0)20 7958 8113 haltit@lshtm.ac.uk

Locations
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United Kingdom
Over 50 countries Worldwide Recruiting
London, United Kingdom
Principal Investigator: Tim Harris, MD         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Rawalpindi Medical College
University of Ibadan
Investigators
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Study Director: Haleema Shakur-Still LSHTM

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01658124     History of Changes
Other Study ID Numbers: ISRCTN11225767
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: December 2018
Keywords provided by London School of Hygiene and Tropical Medicine:
haemorrhage,antifibrinolytic, clinical trial,
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants