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Completed

NCT Number: NCT01500421

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

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.

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Key information

Conditions

Cerebral Infarction Body Temperature Changes Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypothermia Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bispebjerg Hospital

Copenhagen, Capital Region, DK-2400, Denmark

About this study

Ischemic stroke remains a diagnosis with limited treatment opportunities and a treatment with the ability to target patients outside the normal treatment window is wanted.

Therapeutic hypothermia (TH) treatment has long been recognised as a treatment of patients with global ischemia following caridac arrest.

This trial is designed to address the safty and feasibility of TH in acute stroke patients.

Patients arriving in our stroke ward are observed for 3 hours. Only non-remitting patients are allowed into the trial.

Patients are randomized to either therapeutic hypothermia with endovascular catheter + nasopharyngeal induction or endovascular catheter alone in the intensive care unit (ICU) (in Copenhagen, Denmark) or intravenous cold saline infusion followed by surface cooling (in Malmø, Sweden)versus standard treatment in a stoke unit.

Patients brought to the ICU are sedated and mechanically ventilated.

Therapeutic hypothermia is induced with a endovascular catether and a nasopharyngeal catheter. Body temperature is lowered to 33 degrees and sustained for a period of 24 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • National Institute of Health Stroke Scale (NIHSS) score on admission between 5 and 18
  • Inclusion within 24 hours after stroke onset
  • Diagnosis of ischemic stroke verified by MRI, CT or CTP adjudicated by including physician
  • Informed consent from patient or proxy

Exclusion criteria

  • Modified ranking scale (mRS)>2 indicating significant disability before onset of stroke
  • MRI or CT evidence for massive ischemic damage (>50% Middle cerebral artery (MCA) territory)
  • Severe concomitant diseases such as heart failure, chronic obstructive lung disease or known cancer
  • Presently on anticoagulation treatment
  • No informed consent from patient or proxy

Treatment and study plan

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

Other names: Arctic Sun, Medivance, USA

Primary outcomes

  1. Feasibility and safety

    Time frame: 3 month

    Feasibility and safety defined as mortality and morbidity 3 months after ictus

Secondary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 3 months

    mRS score after 7 days and 3 months

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Malmö University

Registry information

Official study title

The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 28, 2011
Registry last updated
Dec 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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