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.

Tranexamic acid use to reduce de blood transfusion in femur fracture patients. Clinical randomized trial with placebo control

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000528-32-ES

Enrollment

276

Registered

2018-04-20

Start date

2018-07-12

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding in patients suffering femur neck fracture MedDRA version: 20.1 Level: LLT Classification code 10053220 Term: Hip injury System Organ Class: 100000004863

Interventions

Trade Name: Amchafibrin Product Name: Tranexamic acid Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic acid CAS Number: 1197-18-8 Current Sponsor code: Tranexamic acid Other

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Tranexamic acid allergy Thrombogenic status Epilepsy Multiple fractures Colour blindness

Design outcomes

Primary

Measure	Time frame
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 Reduction in the calculated blood losses in patients with femur fracture 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	—

Measure

Time frame

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 Reduction in the calculated blood losses in patients with femur fracture 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

Measure	Time frame
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	—

Countries

Spain

Contacts

Public ContactDirección Médica

Parc de Salut Mar

+34932480000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026