drugset / Trial / NCT01535781

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

NCT01535781

Terminated 72 enrolled Hvidovre University Hospital
RandomizedFactorialQuadruple-blindTreatment

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

Timeline

Start
2011-09
Primary completion
2014-06
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 3 g

Indications