Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Total Blood Product Transfusions
研究概览
简要总结
The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham (UAB) Hospital
- •Blunt or penetrating injury
- •UAB highest trauma activation
排除标准
- •Age < 19 years of age
- •Patients with known bleeding diathesis or who are concurrently taking anticoagulant medication
- •Patients with known liver disease
- •Minor patients
- •Pregnant patients (known or suspected pregnancy)
- •Patients who are incarcerated
- •Patients who lack a surrogate
研究组 & 干预措施
Vitamins C and E
Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
干预措施: Vitamin C (Dietary Supplement)
Vitamins C and E
Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
干预措施: Vitamin E (Dietary Supplement)
0.9% saline and sugar pill
100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
干预措施: Saline (for Vitamin C) (Dietary Supplement)
0.9% saline and sugar pill
100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
干预措施: Placebo (for Vitamin E) (Drug)
结局指标
主要结局
Number of Total Blood Product Transfusions
时间窗: From enrollment to 3 days
the number of blood product transfusions for all subjects in each group over the course of 3 days.
Number of Subjects With Ventilator-associated Pneumonia.
时间窗: From enrollment to 3 days
Number of subjects diagnosed with pneumonia and requiring ventilator support.
Number of Participants With Coagulation Abnormalities
时间窗: From enrollment up to 3 days
Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.
Number of Subjects With Organ Injury
时间窗: From enrollment to 3 days
Any injury to internal organs (thoracic, abdominal or cranial cavity)
次要结局
- Mean Number of Days in ICU.(from enrollment up to 60 days post enrollment)
- Number of Subjects With 60-day Survival(from enrollment up to 60 days post enrollment)
- Number of Protocol Violations Per Arm.(from enrollment up to 60 days post enrollment)
- Mean Number of Ventilator-free Days for Subjects(from enrollment up to 60 days post enrollment)
- Mean Number of Hospital Stay Days.(from enrollment up to 60 days post enrollment)
- Number of Subjects Surviving to Day 28(from enrollment up to 28 days post enrollment)
研究者
Jean-Francois Pittet
Principal Investigator
University of Alabama at Birmingham