Effect of Early Administration of TXA in Adult Hip Fractures
Part of paid clinical trials in Grand Blanc, Michigan.
- Sponsor
- Ascension Health
- Study ID
- NCT05047133
- Phase
- PHASE2/PHASE3
- Status
- Recruiting
Conditions
- Postoperative Blood Loss
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Tranexamic acid — DRUGTXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups
Study Details
This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.
Key Dates
- Start date
- Sep 1, 2021
- Status verified
- Sep 2021
- Primary completion
- Jul 1, 2022
- Completion
- Jul 1, 2022
Study Design
- Enrollment
- 170 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Early Adminstration of TXA + Intraoperative TXAThis group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.
- Other: Intraoperative only TXAThis group will only receive the intraoperative TXA.
Primary Outcome Measure
Postoperative Blood Transfusion [ Time Frame: Up to two weeks ]
Central Contacts
- Jacob Hinkley, DO, MS810-606-5669
- Jacob Lytle, DO810-606-5669
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ascension Genesys Hospital | Grand Blanc | Michigan | 48439 |
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