The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery (TXA)
Primary Purpose
Acetabular Fractures
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Acetabular Fractures
Eligibility Criteria
Inclusion Criteria:
- All patients aged 18 or above undergoing acetabular ORIF.
Exclusion Criteria:
- All patients aged below 18 years undergoing acetabulum surgery
- Patients with color-blindness (color vision changes used to assess toxicity)
- Patients with subarachnoid hemorrhage.
- Patients with active intravascular coagulation.
- Patients with a previous history of venous thromboembolism or with a history of hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).
- Prisoners
- Pregnant women
Sites / Locations
- University of Missouri
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Tranexamic
Arm Description
Inactive
Tranexamic acid: anti-fibrinolytic agents
Outcomes
Primary Outcome Measures
Allogenic Blood Transfusion Rates
Number of participant received allogenic blood transfusions.
Units of Packed Red Blood Cells Transfused
Average units packed red blood cells transfused among participants
Secondary Outcome Measures
Number of Participants With a Thromboembolic Event
Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
Estimate Blood Loss
To measure average estimate perioperative blood loss
Full Information
NCT ID
NCT02684851
First Posted
February 11, 2016
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02684851
Brief Title
The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
Acronym
TXA
Official Title
The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 25, 2016 (Actual)
Study Completion Date
July 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.
Detailed Description
In this study, investigators plan to prospectively determine the effect of tranexamic acid on blood loss and outcome after surgery to the acetabulum.
Patients will be randomized into two groups. In this study, investigators plan to administer a 10mg/kg dose within 30 minutes of surgery followed by a 10mg/kg infusion over a 4hr period to the treatment group (for patients weighting over 100kg, a weight of 100kg will be used for the dose calculation). The control group will receive equal volumes of and rates of normal saline.
Research Questions:
Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of allogenic blood transfusion as compared to patients who receive placebo?
Do patients undergoing acetabular ORIF who receive tranexamic acid have reduced peri-operative blood loss as compared to patients who receive placebo?
Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of wound complications (prolonged wound drainage, return to the OR within 30 days, infection)?
Is the use of tranexamic acid cost effective relative to the use of allogenic blood transfusion as a blood loss management strategy in acetabular ORIF?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabular Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive
Arm Title
Tranexamic
Arm Type
Active Comparator
Arm Description
Tranexamic acid: anti-fibrinolytic agents
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Tranexamic acid (anti-fibrinolytic agents )
Intervention Description
Tranexamic acid: anti-fibrinolytic agents
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Allogenic Blood Transfusion Rates
Description
Number of participant received allogenic blood transfusions.
Time Frame
post-operative
Title
Units of Packed Red Blood Cells Transfused
Description
Average units packed red blood cells transfused among participants
Time Frame
perioperative
Secondary Outcome Measure Information:
Title
Number of Participants With a Thromboembolic Event
Description
Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
Time Frame
30 days
Title
Estimate Blood Loss
Description
To measure average estimate perioperative blood loss
Time Frame
perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients aged 18 or above undergoing acetabular ORIF.
Exclusion Criteria:
All patients aged below 18 years undergoing acetabulum surgery
Patients with color-blindness (color vision changes used to assess toxicity)
Patients with subarachnoid hemorrhage.
Patients with active intravascular coagulation.
Patients with a previous history of venous thromboembolism or with a history of hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).
Prisoners
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhav Karunakar, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided
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The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
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