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

NCT ID: NCT01665885

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

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.

Conditions

Ischemic Stroke; Thrombolysis; Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endovascular cooling

Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter

Group Type: ACTIVE_COMPARATOR

ZOLL Thermogard XP

Intervention Type: DEVICE

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.

Surface cooling

Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads

Group Type: ACTIVE_COMPARATOR

BARD/Medivance Arctic Sun 5000

Intervention Type: DEVICE

Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.

Control group

Best medical treatment following international stroke guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA; ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USA; BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA; BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZOLL Circulation, Inc., USA

INDUSTRY

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sven Poli, MD MSc FESO

Dr. Sven Poli, Consultant Neurologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sven Poli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

Stroke Unit, Dept. of Neurology, University Hospital Heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

HAIS-SE

Identifier Type: -

Identifier Source: org_study_id