CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
TH - Endovascular alone (Alsius®, Zoll, USA) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01500421
NCT01500421Phase 2Completed
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The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

Bispebjerg Hospital·interventional·Posted Dec 28, 2011·Updated Dec 28, 2011

In Brief

A Phase 2 clinical trial evaluating TH - Endovascular alone (Alsius®, Zoll, USA), TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA), and 1 other intervention for Cerebral Infarction. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Infarction
CountriesDenmark
CollaboratorsMalmö University

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2011
Enrollment StartOct 1, 2008
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.5 years ago

Interventions

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

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

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

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.

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

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