The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Clotting time in seconds, EXTEM
研究概览
简要总结
This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest.
The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia
Our specific aims are:
- To investigate the whole blood coagulation using the rotational thromboelastometry.
- To investigate the function of platelets
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out of hospital cardiac arrest of presumed cardiac cause
- •Return of spontaneous circulation (ROSC)
- •Glasgow Coma Score < 8
- •Age > 18 years and < 80 years
排除标准
- •> 60 minutes from the circulatory collapse to ROSC
- •Time interval > 4 hours from cardiac arrest to initiation of therapeutic hypothermia
- •Terminal illness
- •Coagulation disorder
- •Unwitnessed asystolia
- •Cerebral performance category 3-4 before the cardiac arrest
- •Severe persistent cardiogenic shock
- •Pregnancy
- •Persistent cardiogenic shock (systolic blood pressure < 80 despite inotropic treatment)
- •New apoplexy or intracerebral hemorrhage
- •Lack of consent from the relatives
- •Lack of consent from the GP
- •Lack of consent from the patient if he/she wakes up and is relevant
研究组 & 干预措施
24 hours hypothermia
Therapeutic hypothermia for 24 hours after reaching target temperature
干预措施: Therapeutic hypothermia (Other)
48 hours hypothermia
Therapeutic hypothermia for 48 hours after reaching target temperature
干预措施: Therapeutic hypothermia (Other)
结局指标
主要结局
Clotting time in seconds, EXTEM
时间窗: After 46 hours
Measured by thomboelastometry on the ROTEM®
Area under the curve, COL-test
时间窗: After 46 hours
Platelet function will be measured using Multiplate®
次要结局
- Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Area under the curve, COL-test(After 22 hours and 70 hours)
- Clotting time in seconds, EXTEM(After 22 hours and 70 hours)
- Clotting time in seconds, -INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Area under the curve,- ADP, ASPI and TRAP-test.(After 22 hours, 46 hours and 70 hours)
- Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Area under the curve, Clot stability test(After 22 hours, 46 hours and 70 hours)
- Area under the curve, Thrombin generation(After 22 hours, 46 hours and 70 hours)