NCT05357079

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

The Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin / Hematocrit in Isolated Operative Posterior Wall Acetabular Fractures: a Prospective, Randomized, Double-blinded, Multicenter Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this prospective, randomized, double-blinded, multi-center study comparing topical TXA with placebo, investigators will determine whether topical TXA utilization in isolated PW acetabular surgery has beneficial or detrimental effects. In order to evaluate the delta between pre-operative and post-operative hemoglobin (blood loss parameters) in patients with isolated PW acetabular fractures that were treated with topical TXA or a placebo, investigators will prospectively enroll all eligible patients with the diagnosis of a closed, isolated, PW acetabular fracture that requires surgical fixation. Isolated PW fractures have been chosen to reduce confounding variables, particularly those associated with more complex fracture patterns including longer surgery duration and blood loss. Each subject will have a pre-operative Hb and Hct drawn on the morning of surgery to establish a baseline level. Prior to surgery, subjects will be computer-randomized by pharmacy to one of two groups: a topical TXA group and a control group. The topical TXA group will be treated with 2 gm/100 ml of normal saline, while the control group will be treated with a placebo (normal saline) in a similar fashion to the TXA experimental group. The surgeon and the operative team will be blinded as to whether the patient receives TXA or placebo. Intraoperative transfusion requirements and estimated blood loss (EBL) will be recorded for every patient. Hemoglobin and hematocrit values will be obtained on postoperative day one and two with routine morning blood draws (typically 5 am-9 am). Post-operative transfusion requirements prior to discharge will be recorded. All patients will have standard low molecular weight heparin DVT prophylaxis for four weeks post-operatively. Prospectively demographic data will be collected. Injury and treatment data collected will include date of injury, mechanism of injury, laterality of injury, medical co-morbidities, associated injuries, date of surgery, operative time, estimated operative blood loss (EBL) from both anesthesia and operative surgeon, calculated operative blood loss, as well as hemoglobin/hematocrit as described, and blood transfusions.

Conditions

• Fracture of Posterior Wall of Acetabulum

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Topical application
DRUG	Normal saline	Topical application

Timeline

• Start date: 2017-08-25
• Primary completion: 2024-08-30
• Completion: 2024-12-02
• First posted: 2022-05-02
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study