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Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE) | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT01665885•University Hospital Heidelberg

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 90 years

Sex

ALL

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
+13 more criteria

Locations (1)

Stroke Unit, Dept. of Neurology, University Hospital Heidelberg

Heidelberg, Germany

Key Dates

Start Date

August 1, 2012

Primary Completion Date

August 1, 2015

Completion Date

November 1, 2015

Last Updated

February 18, 2015

Enrollment

ESTIMATED participants

Conditions

Ischemic StrokeThrombolysisHypothermia

Interventions

ZOLL Thermogard XP

DEVICE

BARD/Medivance Arctic Sun 5000

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

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