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

February 16, 2015 updated by: Dr. Sven Poli, MD MSc FESO, University Hospital Heidelberg

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Stroke Unit, Dept. of Neurology, University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Best medical treatment following international stroke guidelines
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body core temperature
Time Frame: 0 to 48h
Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.
0 to 48h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 to 48h
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.
0 to 48h
Practicability
Time Frame: 0 to 48h
Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).
0 to 48h
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.
0 to d90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

ZOLL Circulation, Inc., USA

Investigators

  • Principal Investigator: Sven Poli, Dr. med., University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

August 13, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAIS-SE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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