The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Feasibility and safety
研究概览
简要总结
This study is designed to investigate the safty and feasibility of therapeutic hypothermia in acute stroke patients. Soon after arrival in the stroke unit patients are randomized to either hypothermia in the intensive care unit (ICU) or standard treatment in the stroke ward.
Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at temperature of 33 degrees for a period of 24 hours.
详细描述
Ischemic stroke remains a diagnosis with limited treatment opportunities and a treatment with the ability to target patients outside the normal treatment window is wanted.
Therapeutic hypothermia (TH) treatment has long been recognised as a treatment of patients with global ischemia following caridac arrest.
This trial is designed to address the safty and feasibility of TH in acute stroke patients.
Patients arriving in our stroke ward are observed for 3 hours. Only non-remitting patients are allowed into the trial.
Patients are randomized to either therapeutic hypothermia with endovascular catheter + nasopharyngeal induction or endovascular catheter alone in the intensive care unit (ICU) (in Copenhagen, Denmark) or intravenous cold saline infusion followed by surface cooling (in Malmø, Sweden)versus standard treatment in a stoke unit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •National Institute of Health Stroke Scale (NIHSS) score on admission between 5 and 18
- •Inclusion within 24 hours after stroke onset
- •Diagnosis of ischemic stroke verified by MRI, CT or CTP adjudicated by including physician
- •Informed consent from patient or proxy
排除标准
- •Modified ranking scale (mRS)>2 indicating significant disability before onset of stroke
- •MRI or CT evidence for massive ischemic damage (>50% Middle cerebral artery (MCA) territory)
- •Severe concomitant diseases such as heart failure, chronic obstructive lung disease or known cancer
- •Presently on anticoagulation treatment
- •No informed consent from patient or proxy
研究组 & 干预措施
TH - Endovacular alone
Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).
干预措施: TH - Endovascular alone (Alsius®, Zoll, USA) (Device)
TH - Endovascular + nasopharyngeal induction
Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only).
干预措施: TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA) (Device)
Standard Treatment
Patients are treated with standard care in the stroke ward.
TH - Surface Cooling
Patients randomized to this arm are cooled to a bodytemperature of 33 degrees with cold saline infusion followed by surface cooling with Arctic Sun Cooling system, Medivance, USA (Malmø only)
干预措施: Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA) (Device)
结局指标
主要结局
Feasibility and safety
时间窗: 3 month
Feasibility and safety defined as mortality and morbidity 3 months after ictus
次要结局
- Modified Rankin Scale (mRS)(3 months)
研究者
Derk W. Krieger MD, Ph.D
Principal Investigator
Bispebjerg Hospital