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

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:

MedlinePlus related topics: Hypothermia

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	August 2014 (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

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:

Heidelberg HYPOthermia 24/7 - Research group, information and contacts This link exits the ClinicalTrials.gov site

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:	August 15, 2012
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:

Hypothermia
Ischemia
Stroke
Cerebral Infarction
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 21, 2013