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

This study is currently recruiting participants.
Verified December 2016 by London School of Hygiene and Tropical Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658124
First Posted: August 6, 2012
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Global trial which will include about 40 countries and over 200 hospitals
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
  Purpose
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 Intervention Phase
Gastrointestinal Bleeding Drug: Tranexamic Acid Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • The primary outcome is death in hospital (cause-specific mortality will also be recorded) [ Time Frame: within 28 days of randomisation ]

Secondary Outcome Measures:
  • Re-bleeding [ Time Frame: 28 days ]
  • Need for salvage surgery or radiological intervention [ Time Frame: 28 days ]
  • Blood transfusion - blood or blood component units transfused [ Time Frame: 28 days ]
  • Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) [ Time Frame: 28 days ]
  • Other adverse medical events (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure) [ Time Frame: 28 days ]
  • Functional status measured using the Katz Index of Independence in Activities of Daily Living [ Time Frame: 28 days ]
  • Time spent at an intensive care unit [ Time Frame: 28 days ]
  • Length of stay in hospital [ Time Frame: 28 days ]
  • Patient status (death, hospital readmission) [ Time Frame: 12 months ]
    Limited to recruiting countries with appropriate databases


Estimated Enrollment: 8000
Study Start Date: January 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic acid
(total dose 8 grams)
Drug: Tranexamic Acid
Placebo Comparator: Placebo
(Sodium Chloride 0.9%)
Drug: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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.
  Contacts and Locations
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
Contact: Haleema Shakur ++44(0)20 7958 8113 haltit@lshtm.ac.uk

Locations
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
Global trial which will include about 40 countries and over 200 hospitals
Investigators
Study Director: Haleema Shakur LSHTM
  More Information

Additional Information:
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     History of Changes
Other Study ID Numbers: ISRCTN11225767
First Submitted: July 26, 2012
First Posted: August 6, 2012
Last Update Posted: December 20, 2016
Last Verified: December 2016

Keywords provided by London School of Hygiene and Tropical Medicine:
haemorrhage,antifibrinolytic, clinical trial,

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants