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

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ClinicalTrials.gov Identifier: NCT01727843
Recruitment Status : Unknown
Verified May 2013 by Rick Lau, Queen's University.
Recruitment status was:  Recruiting
First Posted : November 16, 2012
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Femoral Neck Fracture Drug: Tranexamic Acid Other: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Blood loss [ Time Frame: postop 0-8 days. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rick Lau, PI, Queen's University
ClinicalTrials.gov Identifier: NCT01727843     History of Changes
Other Study ID Numbers: SURG-263-12
6007434 ( Other Identifier: Queen's University REB )
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

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

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