Acetabular Fractures
Conditions
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?
Interventions
DRUGTranexamic Acid
Tranexamic acid: anti-fibrinolytic agents
DRUGPlacebo
Placebo
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allogenic Blood Transfusion Rates | post-operative | Number of participant received allogenic blood transfusions. |
| Units of Packed Red Blood Cells Transfused | perioperative | Average units packed red blood cells transfused among participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Inactive
Placebo: Placebo | 42 |
| Tranexamic Tranexamic acid: anti-fibrinolytic agents
Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents | 45 |
| Total | 87 |
Baseline characteristics
| Characteristic | Placebo | Tranexamic | Total |
|---|---|---|---|
| Age, Customized | 43.7 Years STANDARD_DEVIATION 13.5 | 42.3 Years STANDARD_DEVIATION 16.2 | 43.0 Years STANDARD_DEVIATION 14.9 |
| BMI | 31.2 kg/m^2 STANDARD_DEVIATION 13.5 | 32.1 kg/m^2 STANDARD_DEVIATION 16.2 | 31.7 kg/m^2 STANDARD_DEVIATION 14.7 |
| Co-morbidities Cardiac Disease | 2 Participants | 1 Participants | 3 Participants |
| Co-morbidities Diabetes | 5 Participants | 5 Participants | 10 Participants |
| Letournel Fracture Classification Associated Fractures | 22 Participants | 17 Participants | 39 Participants |
| Letournel Fracture Classification Elementary Fractures | 20 Participants | 28 Participants | 48 Participants |
| Operative time in minutes | 239.4 Minutes STANDARD_DEVIATION 100.6 | 209.9 Minutes STANDARD_DEVIATION 72.3 | 224.7 Minutes STANDARD_DEVIATION 86.6 |
| Orthopaedic Trauma Association Fracture Classification Pelvis, acetabulum, complete articular, associated both column fracture (62C) | 6 Participants | 4 Participants | 10 Participants |
| Orthopaedic Trauma Association Fracture Classification Pelvis, acetabulum, partial articular, isolated column and/or wall fracture (62A) | 22 Participants | 28 Participants | 50 Participants |
| Orthopaedic Trauma Association Fracture Classification Pelvis, acetabulum, partial articular, transverse type fracture (62B) | 14 Participants | 13 Participants | 27 Participants |
| Preoperative Hemoglobin in g/dl | 11.1 g/dl STANDARD_DEVIATION 2.26 | 11.9 g/dl STANDARD_DEVIATION 2.19 | 11.5 g/dl STANDARD_DEVIATION 2.23 |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 32 Participants | 32 Participants | 64 Participants |
| Surgical approach Anterior Approach | 4 Participants | 6 Participants | 10 Participants |
| Surgical approach Combined Anterior/Posterior | 1 Participants | 4 Participants | 5 Participants |
| Surgical approach Posterior Approach | 37 Participants | 35 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 42 |
| other Total, other adverse events | 0 / 45 | 0 / 42 |
| serious Total, serious adverse events | 1 / 45 | 0 / 42 |
Outcome results
Primary
Allogenic Blood Transfusion Rates
Number of participant received allogenic blood transfusions.
Time frame: post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic | Allogenic Blood Transfusion Rates | 21 Participants |
| Placebo | Allogenic Blood Transfusion Rates | 13 Participants |
Primary
Units of Packed Red Blood Cells Transfused
Average units packed red blood cells transfused among participants
Time frame: perioperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic | Units of Packed Red Blood Cells Transfused | 2.65 Units of packed red blood cells | Standard Deviation 1.27 |
| Placebo | Units of Packed Red Blood Cells Transfused | 2.36 Units of packed red blood cells | Standard Deviation 0.81 |
Secondary
Estimate Blood Loss
To measure average estimate perioperative blood loss
Time frame: perioperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic | Estimate Blood Loss | 727.6 mL | Standard Deviation 702.52 |
| Placebo | Estimate Blood Loss | 560.1 mL | Standard Deviation 378.4 |
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?
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic | Number of Participants With a Thromboembolic Event | 1 Participants |
| Placebo | Number of Participants With a Thromboembolic Event | 0 Participants |