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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by London School of Hygiene and Tropical Medicine
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01658124
First received: July 26, 2012
Last updated: December 19, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Re-bleeding [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Need for salvage surgery or radiological intervention [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Blood transfusion - blood or blood component units transfused [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Other adverse medical events (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Functional status measured using the Katz Index of Independence in Activities of Daily Living [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time spent at an intensive care unit [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Length of stay in hospital [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Patient status (death, hospital readmission) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Limited to recruiting countries with appropriate databases


Estimated Enrollment: 8000
Study Start Date: January 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic acid
(total dose 2 grams)
Drug: Tranexamic Acid
Placebo Comparator: Placebo Drug: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01658124     History of Changes
Other Study ID Numbers: ISRCTN11225767
Study First Received: July 26, 2012
Last Updated: December 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 30, 2014