Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

Study Overview
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Brief Summary
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This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain. The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Detailed Description
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Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

Official Title
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Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study

Conditions
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Acetabulum Fractures

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach Exclusion Criteria: Revision surgery Surgery occurring more than 2 weeks post-injury History of blood dyscrasia or renal insufficiency History of any thromboembolic disease Pregnancy or nursing, color vision defects History of retinal detachment/degeneration Intracranial hemorrhage Hypersensitivity to tranexamic acid Contraceptive Use (estrogens/progestins) FEIBA (anti-inhibitor coagulant complex) use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic Acid<br>Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. | Drug: Tranexamic Acid<br>* 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.<br>* Other names: Transamin;|
| Placebo Comparator: Placebo<br>The control group will receive a similar volume load of normal saline and maintenance doses. | Drug: Placebo<br>* The control group will receive a similar volume load of normal saline and maintenance doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative Blood Loss |  | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Required an Allogenic Transfusion |  | Perioperative (hospitalized period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetabulum Fractures, Pelvic Ring Injuries, Tranexamic Acid