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

NCT ID: NCT01727843

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-11-03

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.

Conditions

Femoral Neck Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tranexamic acid

3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

drug and placebo applied topically at end of surgery at hip site.

saline

3000mg/mL saline applied directly to the wound at the end of the surgical procedure

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

applied topically to surgical site in OR.

Interventions

Tranexamic Acid

drug and placebo applied topically at end of surgery at hip site.

Intervention Type: DRUG

placebo

applied topically to surgical site in OR.

Intervention Type: OTHER

Other Intervention Names

Cyklokapron; saline solution

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Jeff Yach

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jeff Yach

PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeff Yach, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's Univeristy

Locations

Queen's Univeristy, KGH

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

6007434

Identifier Type: OTHER

Identifier Source: secondary_id

SURG-263-12

Identifier Type: -

Identifier Source: org_study_id