The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery

Acetabular Fractures Clinical Trial

— TXA  

Official title:

The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684851
• Other study ID #: 10-12-06B
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: July 25, 2017

Study information

• Verified date: January 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: 1. Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of allogenic blood transfusion as compared to patients who receive placebo? 2. Do patients undergoing acetabular ORIF who receive tranexamic acid have reduced peri-operative blood loss as compared to patients who receive placebo? 3. Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo? 4. 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)? 5. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 25, 2017
• Est. primary completion date: July 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Fractures
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid: anti-fibrinolytic agents
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allogenic Blood Transfusion Rates	Number of participant received allogenic blood transfusions.	post-operative
Primary	Units of Packed Red Blood Cells Transfused	Average units packed red blood cells transfused among participants	perioperative
Secondary	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?	30 days
Secondary	Estimate Blood Loss	To measure average estimate perioperative blood loss	perioperative