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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

November 1, 2012
November 16, 2012
November 30, 2018
April 2013
November 3, 2017   (Final data collection date for primary outcome measure)
Blood loss [ Time Frame: postop 0-8 days. ]
Same as current
Complete list of historical versions of study NCT01727843 on ClinicalTrials.gov Archive Site
Not Provided
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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? 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Terminated
15
126
November 3, 2017
November 3, 2017   (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.
Sexes Eligible for Study: All
65 Years to 95 Years   (Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01727843
SURG-263-12
6007434 ( Other Identifier: Queen's University REB )
Yes
Not Provided
Not Provided
Dr. Jeff Yach, Queen's University
Dr. Jeff Yach
Not Provided
Principal Investigator: Jeff Yach, MD Queen's Univeristy
Queen's University
November 2018

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