Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures

Phase 3

Terminated

• Conditions: Femoral Neck Fracture
• Interventions: Other: placebo; Drug: Tranexamic Acid

• Registration Number: NCT01727843
• Lead Sponsor: Dr. Jeff Yach

Brief Summary

Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However, concerns about the prothrombotic side effects of systemic administration of TA has hindered the widespread adoption of this medication in orthopaedic patients due to their high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical application of tranexamic acid has been proposed as a way to mitigate the potential prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following topical application, minimizing its potential systemic thromboembolic side effects. TA has been used topically in total knee arthroplasty, with significant reductions in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture surgery is limited, and there are no studies examining topical use of TA in hip fracture surgery.

Detailed Description

Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by the research assistant will consist of estimated blood loss during surgery, length of stay in hospital, any wound infections as well as any thromboembolic side effects (blood clots in legs and/or heart) that may occur. The number of units of red blood cells transfused will be recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest postoperative hemoglobin levels up to and including post-op day 8 will also be collected as well as any use of ambulatory aids will be recorded on presentation to hospital, discharge and 6 weeks post operatively.

Study Timeline

• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-16
• Study Start: 2013-04
• Primary Completion: 2017-11-03
• Study Completion: 2017-11-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• hip fracture patients
• aged 65 and older.

Exclusion Criteria

• bilateral femoral neck fracture patient and/or one that is not suited to a hemiarthroplasty repair.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	placebo	3000mg/mL saline applied directly to the wound at the end of the surgical procedure
tranexamic acid	Tranexamic Acid	3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.

Primary Outcome Measures

Name	Time	Method
Blood loss	postop 0-8 days.

Trial Locations

Locations (1)

Queen's Univeristy, KGH; 🇨🇦 Kingston, Ontario, Canada