Clinical trial NCT05357079: Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fracture of Posterior Wall of Acetabulum
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Foundation for Orthopedic Trauma
First posted: 2022-05-02
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A. Specific aims

a. To conduct a multi-center study to prospectively 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Hemoglobin (Hb)
timeFrame: Postoperative Day 2
measure: Hematocrit (Hct)
timeFrame: Postoperative Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
Study officials:
References:
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