Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE) (HAIS-SE)
Recruitment status was: Active, not recruiting
|Ischemic Stroke Thrombolysis Hypothermia||Device: ZOLL Thermogard XP Device: BARD/Medivance Arctic Sun 5000||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis|
- Body core temperature [ Time Frame: 0 to 48h ]Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.
- Efficacy [ Time Frame: 0 to 48h ]Secondary efficacy outcome measures include the amount of patients reaching the primary target body core temperature (34°C), the time-frame until reaching 35°C body core temperature, temperature stability during maintenance and rewarming.
- Tolerability [ Time Frame: 0 to 48h ]Tolerability outcome measures include a specific Hypothermia Participant Experience Questionnaire (HPEQ) and the Bedside Shivering Assessment Scale (BSAS) plus correlation with skin temperature, EMG and sNIRS.
- Practicability [ Time Frame: 0 to 48h ]Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).
- Safety [ Time Frame: 0 to d90 ]Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, pneumonia). 0 to 48h: Dose needed of anti-shivering medication, level of sedation (RASS, GCS and BIS), safety laboratory including specific coagulation parameters and monitoring of cerebral auto-regulation including cNIRS and BIS.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Endovascular cooling
Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter
Device: ZOLL Thermogard XP
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution). Cooling catheter placement at the earliest 30min after end of thrombolysis.
Active Comparator: Surface cooling
Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads
Device: BARD/Medivance Arctic Sun 5000
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
No Intervention: Control group
Best medical treatment following international stroke guidelines
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients.
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665885
|Stroke Unit, Dept. of Neurology, University Hospital Heidelberg|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Sven Poli, Dr. med.||University Hospital Heidelberg|