NCT05047133 Effect of Early Administration of TXA in Adult Hip Fractures
| NCT ID | NCT05047133 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Ascension Health |
| Condition | Postoperative Blood Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2022-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 170 participants in total. It began in 2021-09-01 with a primary completion date of 2022-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 1\. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation Exclusion Criteria: 1. Polytrauma patients 2. Previous operation on the ipsilateral hip 3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.) 4. Patients with \< 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI) 5. History of seizure disorder 6. Patients on birth control 7. Pregnant Women 8. Prisoners 9. Active thromboembolic disease (DVT/PE, MI, Stroke)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05047133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Blood Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05047133 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05047133 currently recruiting?
Yes, NCT05047133 is actively recruiting participants. Contact the research team at jacob.hinkley2@ascension.org for enrollment information.
Where is the NCT05047133 trial being conducted?
This trial is being conducted at Grand Blanc, United States.
Who is sponsoring the NCT05047133 clinical trial?
NCT05047133 is sponsored by Ascension Health. The trial plans to enroll 170 participants.