Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
研究概览
简要总结
Hypotheses:
H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls.
H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification.
H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification
详细描述
This study is a prospective, randomized, controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
- •Extremity Wound ≥75cm2 requiring operative intervention
- •Minimal age of 18 years
排除标准
- •The following co-morbidities will result in exclusion from study:
- •Coronary Artery Disease,
- •Diabetes Mellitus (IDDM or T2DM),
- •Peripheral Vascular Disease,
- •Connective tissue disorders,
- •Immunosuppression,
- •Clinically-evident peptic ulcer disease,
- •Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50),
- •Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
- •Severe penetrating or hemorrhagic traumatic brain injury,
- •Endoscopic gastrointestinal interventions,
- •Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
- •Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
- •History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
- •Hepatic Impairment
- •Drugs known to inhibit CYP2C9 Liver Enzymes
- •Subjects known or suspected to be poor CYP2C9 metabolizers
- •Concomitant use with ACE Inhibitors and Angiotension II Antagonists
研究组 & 干预措施
Celebrex
Receive Celebrex
干预措施: Celecoxib (Drug)
结局指标
主要结局
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
时间窗: 3 years
Incidence and severity of HO
次要结局
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial(3 years)