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

Femoral Neck Fracture Clinical Trial

Official title:

Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01727843
• Other study ID #: SURG-263-12
• Secondary ID: 6007434
• Status: Terminated
• Phase: Phase 3
• Start date: April 2013
• Est. completion date: November 3, 2017

Study information

• Verified date: November 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic Acid
drug and placebo applied topically at end of surgery at hip site.

Other:
• placebo
applied topically to surgical site in OR.

Locations

Country	Name	City	State
Canada	Queen's Univeristy, KGH	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Jeff Yach

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss		postop 0-8 days.