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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 : Terminated
First Posted : November 16, 2012
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Jeff Yach, Queen's University

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 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
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : November 3, 2017

Resource links provided by the National Library of Medicine


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




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


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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
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.

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
Kingston, Ontario, Canada, K7L2G7
Sponsors and Collaborators
Dr. Jeff Yach
Investigators
Principal Investigator: Jeff Yach, MD Queen's Univeristy

Responsible Party: Dr. Jeff Yach, 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: November 30, 2018
Last Verified: November 2018

Keywords provided by Dr. Jeff Yach, 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