Haemorrhage following Trauma
Conditions
Interventions
Trade Name: Cyklokapron Injection
Product Name: Tranexamic acid
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Tranexamic Acid
CAS Number: 1197-18-8
Current Sponsor code: BO2AA02
Conc
Sponsors
London School of Hygiene and Tropical Medicine
World Health Organisation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All trauma patients with significant haemorrhage (systolic blood pressure less than 90 mmHg and/or heart rate more than 110 beats per minute), or who are considered to be at risk of significant haemorrhage, and are within 8 hours of the injury, are eligible for trial entry if they appear to be at least 16 years old. Although entry is allowed up to 8 hours from injury, the earlier that patients can be treated the better. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: There are no other pre-specified exclusion criteria. The fundamental eligibility criterion is the responsible doctor’s ‘uncertainty’ as to whether or not to use an antifibrinolytic agent in a particular adult with traumatic haemorrhage. Patients for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Likewise, patients for whom there is considered to be a clear contraindication to antifibrinolytic therapy (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible doctor is substantially uncertain as to whether or not to use an antifibrinolytic, all these patients are eligible for randomisation and should be considered for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: What is the effect of such an infusion on the risk of non-fatal vascular events (either haemorrhagic or occlusive)? ;Primary end point(s): The primary outcome measure is: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). ;Main Objective: What is the effect of the early administration of the anti-fibrinolytic agent tranexamic acid (TXA) on death and transfusion requirement in adult trauma patients with significant haemorrhage, or who are considered to be at risk of significant haemorrhage? | — |
Countries
Belgium, Poland, Portugal, Slovakia, United Kingdom
Outcome results
None listed