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

NCT01665885 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-02-18

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • ZOLL Circulation, Inc., USA

    collaborator INDUSTRY

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Sven Poli, Dr. med. · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-08-31
Completion
2015-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665885 on ClinicalTrials.gov