Suspended

HAIS-SEHAIS-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

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What is being tested

ZOLL Thermogard XP

+ BARD/Medivance Arctic Sun 5000

Device
Who is being recruted

Body Temperature Changes+11

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 90 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorUniversity Hospital Heidelberg
Last updated: February 18, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01665885
Principal SponsorUniversity Hospital Heidelberg
Last updated: February 18, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body Temperature ChangesBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesEmbolism and ThrombosisIschemic StrokeHypothermiaThrombosisStroke

Criteria

6 inclusion criteria required to participate
Age >= 18 and <= 90 years
Informed consent of the patient
Intravenous thrombolysis within 4.5h from symptom onset
Ischemic stroke
Show More Criteria
23 exclusion criteria prevent from participating
AV-block > I°
Acute closed-angle glaucoma
Acute myocardial infarction
Acute pulmonary embolism
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

No Intervention
Best medical treatment following international stroke guidelines

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Stroke Unit, Dept. of Neurology, University Hospital Heidelberg

Heidelberg, GermanyOpen Stroke Unit, Dept. of Neurology, University Hospital Heidelberg in Google Maps
SuspendedOne Study Center