This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Rick Lau, Queen's University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Rick Lau, Queen's University Identifier:
First received: November 1, 2012
Last updated: May 13, 2013
Last verified: May 2013
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
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.

Resource links provided by NLM:

Further study details as provided by Rick Lau, Queen's University:

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

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


Ages Eligible for Study:   65 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01727843

Canada, Ontario
Queen's Univeristy, KGH Recruiting
Kingston, Ontario, Canada, K7L2G7
Contact: Grant   
Principal Investigator: Rick Lau, MD         
Sponsors and Collaborators
Rick Lau
Principal Investigator: Rick Lau, MD Queen's Univeristy
  More Information

Responsible Party: Rick Lau, PI, Queen's University Identifier: NCT01727843     History of Changes
Other Study ID Numbers: SURG-263-12
6007434 ( Other Identifier: Queen's University REB )
Study First Received: November 1, 2012
Last Updated: May 13, 2013

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

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Postoperative Hemorrhage
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on September 19, 2017