Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To detect changes in clotting time in seconds (s), during the first 3 days after target temperature (34 °C) is reached.
研究概览
简要总结
The purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest patients during therapeutic hypothermia compared with normothermia.
详细描述
Treatment with mild therapeutic hypothermia, 32-34 °C for 12-24 hours, has shown to improve the neurologic outcome in comatose survivors of out-of-hospital cardiac arrest. Hypothermia is suspected to inhibit haemostasis and therefore cardiac arrest patients with a risk of bleeding are not treated with therapeutic hypothermia. However, the impact on the coagulation system during mild therapeutic hypothermia, has not yet been fully investigated.
The investigators aim to investigate if mild therapeutic hypothermia influences haemostasis. We are including survivors of cardiac arrest, who are treated with hypothermia for 24-48 hours.
Blood will be sampled during hypothermia and secondly during normothermia. 30 minutes after the blood are sampled it will be analyzed using a sensitive low-tissue-factor assay with rotational thromboelastometry (ROTEM®). All the dynamic coagulation parameters obtained on the ROTEM® at hypothermia and normothermia, respectively, will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest.
排除标准
- •age <18 years.
结局指标
主要结局
To detect changes in clotting time in seconds (s), during the first 3 days after target temperature (34 °C) is reached.
时间窗: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
Clotting time will be measured by thromboelastometry on the ROTEM-analyzer using a low-tissue-factor assay.
次要结局
- To detect changes in the clot formation time (s), during the first 3 days after target temperature (34 °C) is reached.(22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).)
- To detect changes in maximum velocity (mm/min.), during the first 3 days after target temperature (34 °C) is reached.(22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).)
- To detect changes in maximum clot firmness (mm), during the first 3 days after target temperature (34 °C) is reached.(22, 46 and 70 hours after hypothermia is reached. (+/- 2 hours))
- To detect changes in time to maximum velocity (s), during the first 3 days after target temperature (34 °C) is reached.(22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).)