Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mortality Rate
研究概览
简要总结
The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.
详细描述
The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic injury other than ground-level fall, and
- •Complaint of pelvic groin or hip pain, or
- •Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or
- •Hemodynamic instability
排除标准
- •Ground level fall
- •Penetrating pelvis injury without frank evidence of fracture
- •Obviously pregnant patients
- •Patients who are too small or too big for the binder
- •Priority 2 or 3 Trauma
结局指标
主要结局
Mortality Rate
时间窗: 30 day
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
次要结局
- Pain Scores - Visual Analog Scale(At time of arrival to Emergency Department)
- Number of Participants With Skin Complications After Pelvic Binder Application(From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year)
- Length of Stay in Hospital(From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year)
- Number of Patients With Blood Transfusions(48 hours)