Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in patients undergoing operative repair of isolated posterior wall (PW) acetabular fractures.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Foundation for Orthopedic Trauma
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Patients with an isolated, closed, posterior wall acetabular fracture managed surgically within 7 days of injury. Upper extremity fractures that are non-operative and have no impact on weight-bearing status will be included.

2. Patients must be skeletally mature.

Exclusion Criteria:

1. Patients are not skeletally mature.

2. Patients with any concomitant lower extremity, pelvis, or spine injuries.

3. Patient admitted as a polytrauma patient to the trauma service due to injury to an internal organ (head, chest, or abdomen).

4. Patient has an unidentified source of hemorrhage other than acetabular fracture.

5. Patient requires surgery for treatment of concomitant injuries.

6. Patient requires multiple surgeries.

7. Patient has pre-existing thrombus prior to surgery.

8. Patient with a history of prior pulmonary embolus or other thromboembolic disease.

9. Patient with a known bleeding disorder.

10. Patient with a history of renal insufficiency.

11. Patient who is unable to give consent or is unconscious.