Upper and lower gastrointestinal bleeding Haematological Disorders
Conditions
Interventions
Tranexamic acid versus placebo
Patients will be randomised to either tranexamic acid (loading dose 1 g over 10 min then infusion of 3 g over 24 h) or matching placebo (given by intrav
Sponsors
London School of Hygiene and Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All adult patients with acute significant upper or lower gastrointestinal bleeding 2. Where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 30/04/2019: Death from haemorrhage within 5 days of randomisation (all-cause and cause-specific mortality within 28 days will also be recorded: haemorrhage, myocardial infarction, stroke, pulmonary embolism, pneumonia, malignancy, other) Previous primary outcome measure: Death in hospital within 28 days of randomisation (cause-specific mortality will also be recorded: haemorrhage, myocardial infarction, stroke, pulmonary embolism, pneumonia, malignancy, other) (Criteria added 01/12/2017) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/04/2019: 1. Death from haemorrhage within 28 days 2. Re-bleeding 3. Endoscopic, radiological or surgical intervention 4. Blood transfusion ? blood or blood component units transfused 5. Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) 6. Complications (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure) 7. Functional status measured using the Katz Index of Independence in Activities of Daily Living 8. Time spent at an intensive care or high dependency unit 9. Length of stay in hospital 10. Patient status (death, hospital readmission) at 12 months will be ascertained if appropriate databases are available in the recruiting country 11. Adverse events Previous secondary outcome measures: 1. Death from haemorrhage (added 01/12/2017) 2. Re-bleeding 3. Need for salvage surgery or radiological intervention 4. Blood transfusion ? blood or blood component units transfused 5. Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) 6. Other adverse medical events (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure) 7. Functional status measured using the Katz Index of Independence in Activities of Daily Living 8. Time spent at an intensive care unit 9. Length of stay in hospital 10. Patient status (death, hospital readmission) at 12 months will be ascertained if appropriate databases are available in the recruiting country | — |
Countries
Australia, Egypt, Georgia, Ireland, Malaysia, Nepal, Pakistan, Papua New Guinea, Romania, Spain, United Kingdom
Outcome results
None listed