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AzTrials

Cerebral InfarctionPhase 2NCT01500421

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

A Phase 2 study testing TH - Endovascular alone (Alsius®, Zoll, USA), TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA) and Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA) in people with Cerebral Infarction, run by Bispebjerg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Infarction
What is being tested?
TH - Endovascular alone (Alsius®, Zoll, USA), TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA) and Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteDenmark
Study dates
Oct 2008to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Bispebjerg Hospital

    Copenhagen, Capital Region, DK-2400

Other trials in Denmark

About this study

Official title: The Øresund Copenhagen-Malmø Acute Stroke Cooling Trial

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.

Read the detailed 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.

Being tested
TH - Endovascular alone (Alsius®, Zoll, USA), TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA), Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)
Keywords
Hypothermia, Induced
Medical subject headings
Cerebral Infarction, Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

    Also called Arctic Sun, Medivance, USA

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

Study groups in NCT01500421
Study groupRoleWhat they receive
TH - Endovacular aloneExperimentalPatients randomized to this arm are cooled to a bodytemperature of 33 degrees with an endovascular groin catheter (Copenhagen only).
Receives: Device: TH - Endovascular alone (Alsius®, Zoll, USA)
TH - Endovascular + nasopharyngeal inductionExperimentalPatients randomized to this arm are cooled to a bodytemperature of 33 degrees with endovascular catheter along with nasopharyngeal induction (Copenhagen only).
Receives: Device: TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)
Standard TreatmentNo interventionPatients are treated with standard care in the stroke ward.
TH - Surface CoolingExperimentalPatients randomized to this arm are cooled to a bodytemperature of 33 degrees with cold saline infusion followed by surface cooling with Arctic Sun Cooling system, Medivance, USA (Malmø only)
Receives: Device: Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and safety

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

    Measured: 3 month

Secondary outcomes (1)

  1. Modified Rankin Scale (mRS)

    mRS score after 7 days and 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2011 (estimated)
  2. Study startOct 2008
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500421
Sponsor's protocol ID
H-D-2008-105
Status last verified
Dec 2011
First submitted
22 Dec 2011
Last updated
28 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1212/01.wnl.0000129840.66938.75.

    PubMed 15277626

  • Hamann GF, Burggraf D, Martens HK, Liebetrau M, Jager 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. doi: 10.1161/01.STR.0000116866.60794.21. Epub 2004 Feb 19.

    PubMed 14976330

  • 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. doi: 10.1161/01.str.32.8.1847.

    PubMed 11486115

  • 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. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.

    PubMed 17904009

  • 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.

    PubMed 15632543

  • 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. doi: 10.1161/hs0901.095394.

    PubMed 11546893

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TH - Endovascular alone (Alsius®, Zoll, USA), TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA) and Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA) in people with Cerebral Infarction, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and safety (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500421, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2011.

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