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

Primary Purpose

Femoral Neck Fracture

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid
placebo
Sponsored by
Dr. Jeff Yach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fracture focused on measuring fracture, hip, tranexamic acid, topical

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen's Univeristy, KGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tranexamic acid

saline

Arm Description

3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.

3000mg/mL saline applied directly to the wound at the end of the surgical procedure

Outcomes

Primary Outcome Measures

Blood loss

Secondary Outcome Measures

Full Information

First Posted
November 1, 2012
Last Updated
November 28, 2018
Sponsor
Dr. Jeff Yach
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1. Study Identification

Unique Protocol Identification Number
NCT01727843
Brief Title
Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures
Official Title
Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Jeff Yach

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
fracture, hip, tranexamic acid, topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid
Arm Type
Experimental
Arm Description
3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
3000mg/mL saline applied directly to the wound at the end of the surgical procedure
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklokapron
Intervention Description
drug and placebo applied topically at end of surgery at hip site.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
saline solution
Intervention Description
applied topically to surgical site in OR.
Primary Outcome Measure Information:
Title
Blood loss
Time Frame
postop 0-8 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Yach, MD
Organizational Affiliation
Queen's Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Univeristy, KGH
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2G7
Country
Canada

12. IPD Sharing Statement

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

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