Overview

Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?

Status:
Terminated

Trial end date:
2014-08-01

Target enrollment:
0

Participant gender:
All

Summary

The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures. Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture. An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hvidovre University Hospital

Treatments:

Tranexamic Acid

Criteria

Inclusion Criteria:

- Patients planned to undergo osteosynthesis with short intramedullary nail for a
pertrochanteric hip fracture.

- ASA score 3, 2 or 1

Exclusion Criteria:

- Allergy for tranexamic acid

- Clinical signs of acute thromboembolic event

- Renal function impairment (S-creatinin>120micromol/l)

- Active thrombotic disease or DIC

- K-vitamin antagonist treatment

- Malignancy

- Pathological fracture

- Previously operated in same hip

- BW > 100kg