Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2018 |
| Start Date: | June 2013 |
| End Date: | December 2016 |
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study
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.
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.
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.
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.
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
We found this trial at
1
site
Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Brett D Crist, MD
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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