Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE) (HAIS-SE)
|ClinicalTrials.gov Identifier: NCT01665885|
Recruitment Status : Unknown
Verified June 2013 by Dr. Sven Poli, MD MSc FESO, University Hospital Heidelberg.
Recruitment status was: Active, not recruiting
First Posted : August 15, 2012
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Thrombolysis Hypothermia||Device: ZOLL Thermogard XP Device: BARD/Medivance Arctic Sun 5000||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||November 2015|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665885
|Stroke Unit, Dept. of Neurology, University Hospital Heidelberg|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Sven Poli, Dr. med.||University Hospital Heidelberg|