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Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund)

NCT01500421 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-12-28

No results posted yet for this study

Summary

This study is designed to investigate the safty and feasibility of therapeutic hypothermia in acute stroke patients. Soon after arrival in the stroke unit patients are randomized to either hypothermia in the intensive care unit (ICU) or standard treatment in the stroke ward.

Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at temperature of 33 degrees for a period of 24 hours.

Conditions

  • Cerebral Infarction

Interventions

DEVICE

TH - Endovascular alone (Alsius®, Zoll, USA)

Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).

DEVICE

TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)

Patient are cooled with a groin endovascular catheter (Alsius®, Zoll, USA) + a nasopharyngeal induction catheter (Rhinochill®, Benechill, USA) in the nostrils. The nasopharyngeal induction is designed to give a more quick and localised brain cooling.

DEVICE

Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)

Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling

Sponsors & Collaborators

  • Malmö University

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Denmark

Study Locations

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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 NCT01500421 on ClinicalTrials.gov