An Early Phase 1 interventional study of Tranexamic Acid and Normal saline in Fracture of Posterior Wall of Acetabulum, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by University of Cincinnati · Early Phase 1, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 94 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 gm TXA/100 ml of normal saline
Drug: Tranexamic Acid
Normal saline
Drug: Normal saline
Topical application
Also known as: Cyklokapron, Pfizer
Topical application
Hemoglobin (Hb)
Hemoglobin (Hb) results
Time frame: Postoperative Day 2
Hematocrit (Hct)
Hematocrit (Hct) results
Time frame: Postoperative Day 2
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Cincinnati