The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- 30 day survival
研究概览
简要总结
The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.
详细描述
Study Objective
The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds, specifically addressing:
- baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
- randomization compliance rate.
- ease of protocol implementation in the out-of-hospital setting.
- adverse rate of Hypertonic Saline Dextran (HSD) infusion.
The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial assessment of Glasgow Coma Score (GCS) 8 or less
- •Blunt traumatic mechanism of injury
排除标准
- •Known pregnancy
- •Penetrating primary injury
- •VSA prior to randomization; previous intravenous therapy ≥ 50 ml
- •Time interval between arrival at scene and intravenous access exceeds four hours
- •Amputation of above wrist or ankle
- •Any burn (thermal, chemical, electrical, radiation)
- •Suspected hypothermia
- •Asphyxia (strangulation, hanging, choking, suffocation, drowning) and fall from height ≤ 1m or ≤ 5 stairs.
结局指标
主要结局
30 day survival
时间窗: 30 days after discharge
次要结局
- Survival(48 hrs after admission)
- Functional neurological outcomes at 4 months(4 Months)
- Neuropsychological testing at 4 months(4 months)
- Neuropsychological testing at 1 year(1 year)
- Physiologic parameters indicative of organ dysfunction(4 months)
- Structural parameters indicative of brain injury or dysfunction at 4 months(4 months)
- Serum inflammatory markers measured on arrival, 12, 24, 48 hours later(12, 24, 48 hours later)
研究者
Dr. Laurie Morrison
Clinician Scientist
Unity Health Toronto