Acetabulum Fractures
Conditions
Keywords
Acetabulum Fractures, Pelvic Ring Injuries, Tranexamic Acid
Brief summary
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
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.
Interventions
DRUGTranexamic Acid
10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
DRUGPlacebo
The control group will receive a similar volume load of normal saline and maintenance doses.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra-operative Blood Loss | Day of Surgery |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants That Required an Allogenic Transfusion | Perioperative (hospitalized period) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery. | 42 |
| Placebo Patients in the control group received an equal volume and rate of normal saline. | 46 |
| Total | 88 |
Baseline characteristics
| Characteristic | Placebo | Total | Tranexamic Acid |
|---|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 16.1 | 40.7 years STANDARD_DEVIATION 15.9 | 41.7 years STANDARD_DEVIATION 15.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 46 Participants | 88 Participants | 42 Participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 11 Participants |
| Sex: Female, Male Male | 34 Participants | 65 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 46 |
| other Total, other adverse events | 0 / 42 | 0 / 46 |
| serious Total, serious adverse events | 1 / 42 | 0 / 46 |
Outcome results
Primary
Intra-operative Blood Loss
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid | Intra-operative Blood Loss | 727.6 Milliliters | Standard Deviation 702.52 |
| Placebo | Intra-operative Blood Loss | 560.1 Milliliters | Standard Deviation 378.4 |
Secondary
Number of Participants That Required an Allogenic Transfusion
Time frame: Perioperative (hospitalized period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid | Number of Participants That Required an Allogenic Transfusion | 21 Participants |
| Placebo | Number of Participants That Required an Allogenic Transfusion | 15 Participants |