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

November 1, 2012
May 13, 2013
April 2013
April 2014   (final data collection date for primary outcome measure)
Blood loss [ Time Frame: postop 0-8 days. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01727843 on ClinicalTrials.gov Archive Site
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Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures
Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.

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?

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Femoral Neck Fracture
  • Drug: Tranexamic Acid
    drug and placebo applied topically at end of surgery at hip site.
    Other Name: Cyklokapron
  • Other: placebo
    applied topically to surgical site in OR.
    Other Name: saline solution
  • Experimental: tranexamic acid
    3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: saline
    3000mg/mL saline applied directly to the wound at the end of the surgical procedure
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
65 Years to 95 Years
No
Canada
 
NCT01727843
SURG-263-12, 6007434
Yes
Rick Lau, Queen's University
Rick Lau
Not Provided
Principal Investigator: Rick Lau, MD Queen's Univeristy
Queen's University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP