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

NCT01727843 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-11-30

No results posted yet for this study

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.

Conditions

  • Femoral Neck Fracture

Interventions

DRUG

Tranexamic Acid

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

OTHER

placebo

applied topically to surgical site in OR.

Sponsors & Collaborators

  • Dr. Jeff Yach

    lead OTHER

Principal Investigators

  • Jeff Yach, MD · Queen's Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-11-03
Completion
2017-11-03

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01727843 on ClinicalTrials.gov