E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastrointestinal hemorrhage |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017960 |
E.1.2 | Term | Gastrointestinal hemorrhage |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary outcome is death in hospital within 28 days of randomisation (cause-specific mortality will also be recorded). Cause specific mortality will be described as per section 3.1 of the outcome form (haemorrhage, myocardial infarction, stroke, pulmonary embolism, pneumonia, malignancy, other). |
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E.2.2 | Secondary objectives of the trial |
a)Death from haemorrhage a)Re-bleeding b)Need for surgery or radiological intervention c)Blood product transfusion d)Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) e)Other complications (significant cardiac event, sepsis, pneumonia, respiratory failure, renal failure, liver failure, seizures) f)Patient’s self care capacity using the Katz Index of Independence in Activities of Daily Living g)Days spent in intensive care unit or high dependency unit |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult (18 years and over) with significant gastrointestinal bleeding • Where the responsible clinician is substantially uncertain as to whether or not to use tranexamic acid
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E.4 | Principal exclusion criteria |
• Patients for whom the responsible clinician considers there is a clear indication for tranexamic acid. • Patients for whom the responsible clinician considers there is a clear contraindication for tranexamic acid.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is death in hospital within 28 days of randomisation (cause-specific mortality will also be recorded). Cause specific mortality will be described as per section 3.1 of the outcome form (haemorrhage, myocardial infarction, stroke, pulmonary embolism, pneumonia, malignancy, other). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28 days after randomisation, at hospital discharge, or at death, whichever occurs first. |
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E.5.2 | Secondary end point(s) |
a)Death from haemorrhage a)Re-bleeding b)Need for surgery or radiological intervention c)Blood product transfusion d)Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) e)Other complications (significant cardiac event, sepsis, pneumonia, respiratory failure, renal failure, liver failure, seizures) f)Patient’s self care capacity using the Katz Index of Independence in Activities of Daily Living g)Days spent in intensive care unit or high dependency unit |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
28 days after randomisation, at discharge from the randomising hospital, or at death (whichever occurs first) for all the above secondary outcome, except (h) "Patient status (death, hospital readmission) at 12 months", which will be evaluated at 12 months after randomisation (England and Wales, only) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 300 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Albania |
Belgium |
Croatia |
Czech Republic |
Egypt |
France |
Georgia |
Greece |
Ireland |
Italy |
Lithuania |
Mexico |
Nigeria |
Pakistan |
Portugal |
Romania |
Slovakia |
Slovenia |
Spain |
Uganda |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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After 12,000 patients have been recruited (anticipated to be completed by 31/05/2019), the trial will end when follow-up of the last patient recruited is completed. Follow up is up to 28 days after randomisation for all countries apart from the UK, where follow up is 12 months after randomization. The trial may be terminated early by the Trial Steering Committee on the recommendation of the Independent Data Monitoring Committee on their interim reviews of the unblinded data. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |