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

Cerebral Infarction Clinical Trial

Official title:

The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500421
• Other study ID #: H-D-2008-105
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2011
• Last updated: December 27, 2011
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction

Intervention

Device:
• TH - Endovascular alone (Alsius®, Zoll, USA)
Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
• 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.
• 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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Malmö University

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

De Georgia MA, Krieger DW, Abou-Chebl A, Devlin TG, Jauss M, Davis SM, Koroshetz WJ, Rordorf G, Warach S. Cooling for Acute Ischemic Brain Damage (COOL AID): a feasibility trial of endovascular cooling. Neurology. 2004 Jul 27;63(2):312-7. — View Citation

Hamann GF, Burggraf D, Martens HK, Liebetrau M, Jäger G, Wunderlich N, DeGeorgia M, Krieger DW. Mild to moderate hypothermia prevents microvascular basal lamina antigen loss in experimental focal cerebral ischemia. Stroke. 2004 Mar;35(3):764-9. Epub 2004 Feb 19. — View Citation

Krieger DW, De Georgia MA, Abou-Chebl A, Andrefsky JC, Sila CA, Katzan IL, Mayberg MR, Furlan AJ. Cooling for acute ischemic brain damage (cool aid): an open pilot study of induced hypothermia in acute ischemic stroke. Stroke. 2001 Aug;32(8):1847-54. — View Citation

Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. — View Citation

Milhaud D, Thouvenot E, Heroum C, Escuret E. Prolonged moderate hypothermia in massive hemispheric infarction: clinical experience. J Neurosurg Anesthesiol. 2005 Jan;17(1):49-53. — View Citation

Schwab S, Georgiadis D, Berrouschot J, Schellinger PD, Graffagnino C, Mayer SA. Feasibility and safety of moderate hypothermia after massive hemispheric infarction. Stroke. 2001 Sep;32(9):2033-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety	Feasibility and safety defined as mortality and morbidity 3 months after ictus	3 month	Yes
Secondary	Modified Rankin Scale (mRS)	mRS score after 7 days and 3 months	3 months	Yes