The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
- Registration Number
- NCT02684851
- Lead Sponsor
- Wake Forest University Health Sciences
- 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:
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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- All patients aged 18 or above undergoing acetabular ORIF.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Inactive Tranexamic Tranexamic Acid Tranexamic acid: anti-fibrinolytic agents
- Primary Outcome Measures
Name Time Method Units of Packed Red Blood Cells Transfused perioperative Average units packed red blood cells transfused among participants
Allogenic Blood Transfusion Rates post-operative Number of participant received allogenic blood transfusions.
- Secondary Outcome Measures
Name Time Method Number of Participants With a Thromboembolic Event 30 days Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
Estimate Blood Loss perioperative To measure average estimate perioperative blood loss
Trial Locations
- Locations (2)
University of Missouri
🇺🇸Columbia, Missouri, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States