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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Rick Lau, Queen's University
ClinicalTrials.gov Identifier:
NCT01727843
First received: November 1, 2012
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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. Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures?


Condition Intervention Phase
Femoral Neck Fracture
Drug: Tranexamic Acid
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Blood loss [ Time Frame: postop 0-8 days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tranexamic acid
3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.
Drug: Tranexamic Acid
drug and placebo applied topically at end of surgery at hip site.
Other Name: Cyklokapron
Placebo Comparator: saline
3000mg/mL saline applied directly to the wound at the end of the surgical procedure
Other: placebo
applied topically to surgical site in OR.
Other Name: saline solution

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727843

Locations
Canada, Ontario
Queen's Univeristy, KGH Recruiting
Kingston, Ontario, Canada, K7L2G7
Contact: Grant       granth@queensu.ca   
Principal Investigator: Rick Lau, MD         
Sponsors and Collaborators
Rick Lau
Investigators
Principal Investigator: Rick Lau, MD Queen's Univeristy
  More Information

No publications provided

Responsible Party: Rick Lau, PI, Queen's University
ClinicalTrials.gov Identifier: NCT01727843     History of Changes
Other Study ID Numbers: SURG-263-12, 6007434
Study First Received: November 1, 2012
Last Updated: May 13, 2013
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
fracture
hip
tranexamic acid
topical

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Postoperative Hemorrhage
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Hemorrhage
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014