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

Not Applicable

Terminated

• Conditions: Hip Fracture; Anemia
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT01535781
• Lead Sponsor: Hvidovre University Hospital

Brief 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

Detailed Description

Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.

Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid	Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion.
Placebo	Placebo	Patients are given saline instead of tranexamic acid in the placebo group

Primary Outcome Measures

Name	Time	Method
Total Blood Loss	time in hospital (approximately 10 days)	Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days and 90 days follow up	Mortality is obtained via central personal registration system (Danish CPR system)
Transfusions	From admission to third day after surgery.	Information from local blood bank
Thromboembolic Event (clinical, NOT by routine ultrasound measurement)	90 days follow up	Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark