Research about the administration of an intravenous drug (trantexamic acid)in order to reduce the amount of trasnsfusion in patients suffering femur fracture. An experiment involving patients is designed: two groups of patients are created by chance allocation, in one the tranexamic acid is administered and in the other an innert substance. After that we compare the amount of blood cell bags needed.
Phase 1
- Conditions
- Bleeding in patients suffering femur neck fractureMedDRA version: 20.1Level: LLTClassification code 10053220Term: Hip injurySystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2018-000528-32-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 276
Inclusion Criteria
Age > 64
Femur fracture that needs surgical treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 276
Exclusion Criteria
Tranexamic acid allergy
Thrombogenic status
Epilepsy
Multiple fractures
Colour blindness
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduction in the number of patients who need a red blood cell transfusion after femur fracture;Secondary Objective: Reduction in the amount of red cell packs transfused in patients with femur fracture<br>Reduction in the calculated blood losses in patients with femur fracture<br>Assessment of safety of tranexamic acid in patients with femur fracture;Primary end point(s): Reduction in the transfusion rate of 30%;Timepoint(s) of evaluation of this end point: 30 days after trauma femur fracture
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Reduction in 50% of patients who need more than one red blood cell concentrate;Timepoint(s) of evaluation of this end point: 30 days after trauma femur fracture