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

Primary Purpose

Ischemic Stroke, Thrombolysis, Hypothermia

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
ZOLL Thermogard XP
BARD/Medivance Arctic Sun 5000
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring hypothermia, induction of hypothermia, non invasive cooling, external cooling, surface cooling, endovascular cooling, cooling catheter, stroke, shivering, neuro monitoring, coagulation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stroke Unit, Dept. of Neurology, University Hospital Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Endovascular cooling

Surface cooling

Control group

Arm Description

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

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

Best medical treatment following international stroke guidelines

Outcomes

Primary Outcome Measures

Body core temperature
Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.

Secondary Outcome Measures

Efficacy
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
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
Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).
Safety
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.

Full Information

First Posted
August 13, 2012
Last Updated
February 16, 2015
Sponsor
University Hospital Heidelberg
Collaborators
ZOLL Circulation, Inc., USA
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1. Study Identification

Unique Protocol Identification Number
NCT01665885
Brief Title
Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)
Acronym
HAIS-SE
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
Collaborators
ZOLL Circulation, Inc., USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Thrombolysis, Hypothermia
Keywords
hypothermia, induction of hypothermia, non invasive cooling, external cooling, surface cooling, endovascular cooling, cooling catheter, stroke, shivering, neuro monitoring, coagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular cooling
Arm Type
Active Comparator
Arm Description
Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter
Arm Title
Surface cooling
Arm Type
Active Comparator
Arm Description
Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Best medical treatment following international stroke guidelines
Intervention Type
Device
Intervention Name(s)
ZOLL Thermogard XP
Other Intervention Name(s)
ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA, ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USA
Intervention Description
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
Intervention Name(s)
BARD/Medivance Arctic Sun 5000
Other Intervention Name(s)
BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA, BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USA
Intervention Description
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
Primary Outcome Measure Information:
Title
Body core temperature
Description
Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.
Time Frame
0 to 48h
Secondary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
0 to 48h
Title
Tolerability
Description
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.
Time Frame
0 to 48h
Title
Practicability
Description
Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).
Time Frame
0 to 48h
Title
Safety
Description
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.
Time Frame
0 to d90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stroke Unit, Dept. of Neurology, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

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

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