To evaluate the safety and efficacy of using tissue plasminogen activator (tPA) combined with hypothermia within 3 hours of stroke onset.
- Tissue plasminogen activator (Activase®)Drug
Other Names: rtpa Intervention Desc: Thrombolytic
- Hypothermia Device
Intervention Desc: Reduction of brain temperature and body temperature for neuroprotection
Monocenter study; interventional; randomized; active control; safety study.
Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study. Patients that meet the inclusion criteria will be assigned to two different treatment groups including 25 patients each (n=25).
Patients who are assigned to the hypothermia receive ice cold saline (4°C) infusion by 25ml/kg body weight. At the same time, they are treated by pethidine iv and buspirone p.o. to prevent and treat cold-induced shivering. 30 to 90 min after the end of t-PA infusion a cooling catheter (ICY, Alsius cooperation) is placed in the femoral vein and the goal temperature is set to 35°C bladder temperature. Cooling to 35°C is maintained for 24 hours and followed by controlled rewarming. Stroke severity is frequently investigated. MR-investigations are part of the protocol to examine the evolution of stroke during hypothermia and after rewarming. After hospital discharge, patients are examined on day 30 and 90 after stroke onset.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Safety and feasibility of hypothermia of 35°C in awake thrombolysed patients.|
|Secondary||NIHSS at 24 hours, at 30, and 90, modified Rankin Scale score and NIHSS at 30 days, mRS at 90 days. MRT stroke volume after 24hrs and 72 hrs, incidence and volume of hemorrhage on MRI.|