TerminatedNot Applicable

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

Stopped: Recruiting slower than expected.

Denmark72 participantsStarted 2011-09

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Total Blood Loss

Timeframe: time in hospital (approximately 10 days)

Trial details

NCT IDNCT01535781

SponsorHvidovre University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Hip Fracture trials