The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | December 2017 |
| Contact: | Rachel Seymour, PhD |
| Email: | Rachel.Seymour@carolinashealthcare.org |
| Phone: | 704-355-6969 |
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.
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.
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?
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?
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
We found this trial at
1
site
1000 Blythe Blvd
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Madhav Karunakar, MD
Phone: 704-355-6969
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