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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Hematocrit (Hct)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients must be skeletally mature.
排除标准
- •Patients are not skeletally mature.
- •Patients with any concomitant lower extremity, pelvis, or spine injuries.
- •Patient admitted as a polytrauma patient to the trauma service due to injury to an internal organ (head, chest, or abdomen).
- •Patient has an unidentified source of hemorrhage other than acetabular fracture.
- •Patient requires surgery for treatment of concomitant injuries.
- •Patient requires multiple surgeries.
- •Patient has pre-existing thrombus prior to surgery.
- •Patient with a history of prior pulmonary embolus or other thromboembolic disease.
- •Patient with a known bleeding disorder.
- •Patient with a history of renal insufficiency.
- •Patient who is unable to give consent or is unconscious.
研究组 & 干预措施
Topical TXA Treatment
2 gm TXA/100 ml of normal saline
干预措施: Tranexamic Acid (Drug)
No Topical Treatment
Normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Hematocrit (Hct)
时间窗: Postoperative Day 2
Hematocrit (Hct) results
Hemoglobin (Hb)
时间窗: Postoperative Day 2
Hemoglobin (Hb) results
次要结局
未报告次要终点
研究者
Michael Archdeacon
Professor & Chair
University of Cincinnati