A Phase 3 interventional study of Tranexamic Acid and Placebo in Acetabular Fractures, sponsored by Wake Forest University Health Sciences. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Wake Forest University Health Sciences · Phase 3, Interventional, and Treatment
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.
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:
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Inactive
Drug: Placebo
Tranexamic acid: anti-fibrinolytic agents
Drug: Tranexamic Acid
Tranexamic acid: anti-fibrinolytic agents
Also known as: Tranexamic acid (anti-fibrinolytic agents )
Placebo
Allogenic Blood Transfusion Rates
Number of participant received allogenic blood transfusions.
Time frame: post-operative
Units of Packed Red Blood Cells Transfused
Average units packed red blood cells transfused among participants
Time frame: perioperative
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
Estimate Blood Loss
To measure average estimate perioperative blood loss
Time frame: perioperative
| Milestone | Placebo | Tranexamic |
|---|---|---|
| Started | 42 | 45 |
| Completed | 42 | 45 |
| Not completed | 0 | 0 |
Number of participant received allogenic blood transfusions.
| Participants | Tranexamic | Placebo |
|---|---|---|
| Allogenic Blood Transfusion Rates | 21 | 13 |
Average units packed red blood cells transfused among participants
| Units of packed red blood cells | Tranexamic | Placebo |
|---|---|---|
| Units of Packed Red Blood Cells Transfused | 2.65 ± 1.27 | 2.36 ± 0.81 |
Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
| Participants | Tranexamic | Placebo |
|---|---|---|
| Number of Participants With a Thromboembolic Event | 1 | 0 |
To measure average estimate perioperative blood loss
| mL | Tranexamic | Placebo |
|---|---|---|
| Estimate Blood Loss | 727.6 ± 702.52 | 560.1 ± 378.4 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tranexamic | 0/45 (0%) | 1/45 (2.2%) | 0/45 (0%) |
| Placebo | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Event | Tranexamic | Placebo |
|---|---|---|
| Pulmonary EmbolusRespiratory, thoracic and mediastinal disorders | 1/45 | 0/42 |
| Age, Customized(Years) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Mean | 43.7 ± 13.5 | 42.3 ± 16.2 | 43.0 ± 14.9 |
| Sex: Female, Male(Participants) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Female | 10 | 13 | 23 |
| Male | 32 | 32 | 64 |
| BMI(kg/m^2) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Mean | 31.2 ± 13.5 | 32.1 ± 16.2 | 31.7 ± 14.7 |
| Co-morbidities(Participants) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Cardiac Disease | 2 | 1 | 3 |
| Diabetes | 5 | 5 | 10 |
| Surgical approach(Participants) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Posterior Approach | 37 | 35 | 72 |
| Anterior Approach | 4 | 6 | 10 |
| Combined Anterior/Posterior | 1 | 4 | 5 |
| Operative time in minutes(Minutes) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Mean | 239.4 ± 100.6 | 209.9 ± 72.3 | 224.7 ± 86.6 |
| Preoperative Hemoglobin in g/dl(g/dl) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Mean | 11.1 ± 2.26 | 11.9 ± 2.19 | 11.5 ± 2.23 |
| Letournel Fracture Classification(Participants) | Placebo | Tranexamic | Total |
|---|---|---|---|
| Associated Fractures | 22 | 17 | 39 |
| Elementary Fractures | 20 | 28 | 48 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — undecided
The record gives a start of Oct 2012, a primary completion of Jul 2016 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2021, 4 years 5 months after primary completion.
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Studies of the drug tested here: Tranexamic Acid
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