Cerebral Infarction
Conditions
Keywords
Hypothermia, Induced
Brief summary
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.
Detailed description
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. Patients brought to the ICU are sedated and mechanically ventilated. Therapeutic hypothermia is induced with a endovascular catether and a nasopharyngeal catheter. Body temperature is lowered to 33 degrees and sustained for a period of 24 hours.
Interventions
DEVICEIntravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)
Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling
DEVICETH - Endovascular alone (Alsius®, Zoll, USA)
Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
DEVICETH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)
Patient are cooled with a groin endovascular catheter (Alsius®, Zoll, USA) + a nasopharyngeal induction catheter (Rhinochill®, Benechill, USA) in the nostrils. The nasopharyngeal induction is designed to give a more quick and localised brain cooling.
Sponsors
Malmö University
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and safety | 3 month | Feasibility and safety defined as mortality and morbidity 3 months after ictus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 3 months | mRS score after 7 days and 3 months |
Countries
Denmark
Outcome results
None listed