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Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital Heidelberg
Sponsor:
Collaborator:
ZOLL Circulation, Inc., USA
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01665885
First received: August 13, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Thrombolysis
Hypothermia
Device: ZOLL Thermogard XP
Device: BARD/Medivance Arctic Sun 5000
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Body core temperature [ Time Frame: 0 to 48h ] [ Designated as safety issue: No ]
    Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 0 to 48h ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).

  • Safety [ Time Frame: 0 to d90 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.
Other Names:
  • ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA
  • ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USA
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.
Other Names:
  • BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA
  • BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USA
No Intervention: Control group
Best medical treatment following international stroke guidelines

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke
  • Intravenous thrombolysis within 4.5h from symptom onset
  • Informed consent of the patient
  • NIHSS score ≥ 2 and ≤ 20
  • Age ≥ 18 and ≤ 90 years
  • Placement of cooling catheter / cooling pads within 6h from symptom onset

Exclusion Criteria:

  • (Expected) intubation (e.g. for interventional treatment)
  • Pregnancy
  • Body weight > 120kg
  • Body height < 150cm
  • Life-expectancy < 3 months
  • Fever > 38.5°C at screening
  • Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
  • Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
  • Possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter
  • Acute pulmonary embolism
  • Acute myocardial infarction
  • Severe cardiac insufficiency (NYHA ≥ III)
  • Threatening ventricular dysrhythmia
  • QTc-interval > 450ms
  • Bradycardia < 50/min
  • Sick-Sinus-Syndrom
  • AV-block > I°
  • Severe infection with bacteremia or sepsis ≤ 72h
  • Severe renal (GFR < 30ml/min) or liver insufficiency (Child-Pugh C)
  • Myopathy
  • Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine.
  • Treatment with MAO-inhibitors ≤ 14 days
  • Acute closed-angle glaucoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665885

Contacts
Contact: Sven Poli, Dr. med. 0049 6221 56 ext 0 sven.poli@med.uni-heidelberg.de

Locations
Germany
Stroke Unit, Dept. of Neurology, University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Sven Poli, Dr. med.    0049 6221 56 ext 0    sven.poli@med.uni-heidelberg.de   
Principal Investigator: Sven Poli, Dr. med.         
Sub-Investigator: Christian Hametner, Dr. med.         
Sub-Investigator: Jan C Purrucker, Dr. med.         
Sub-Investigator: Miriam Priglinger, Dr. med.         
Sub-Investigator: Maxim Bartz         
Sub-Investigator: Marek Sykora, MD, PhD         
Sponsors and Collaborators
University Hospital Heidelberg
ZOLL Circulation, Inc., USA
Investigators
Principal Investigator: Sven Poli, Dr. med. University Hospital Heidelberg
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Sven Poli, Dr. Sven Poli, Consultant Neurologist, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01665885     History of Changes
Other Study ID Numbers: HAIS-SE
Study First Received: August 13, 2012
Last Updated: June 21, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Heidelberg:
hypothermia
induction of hypothermia
non invasive cooling
external cooling
surface cooling
endovascular cooling
cooling catheter
stroke
shivering
neuro monitoring
coagulation

Additional relevant MeSH terms:
Cerebral Infarction
Hypothermia
Ischemia
Stroke
Body Temperature Changes
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014