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Acute Ischemic StrokePhase 3EuroHYP-1NCT01833312

Cooling Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke

A Phase 3 study testing Hypothermia, Buspirone and Pethidine in people with Acute Ischemic Stroke, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Hypothermia, Buspirone and Pethidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteGermany
Study dates
Jul 2013to 31 Jul 2018
Phase
Phase 3
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

  • Written informed consent obtained from the patient or his/her legally acceptable representative or under such other arrangements as may be legally established in participating countries
  • Patients of both sexes aged ≥18 years
  • Estimated body weight of 50 up to and including 120kg
  • Diagnosis of acute ischaemic stroke
  • Possibility to start therapeutic hypothermia within 6 hours after onset of stroke
  • Possibility to start therapeutic hypothermia within 150 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site or within 150 minutes after start of endovascular treatment, if this is later
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  • Possibility to start therapeutic hypothermia within 150 minutes after admission to trial site in patients not receiving thrombolysis or in patients who have received thrombolysis at a different site
  • mRS score ≤2 prior to onset of stroke
  • NIHSS score ≥6
  • GCS motor response subscale score ≥5

Who cannot join

  • Use of monoamineoxidase inhibitors in the 14 days prior to screening
  • Current use of medication interacting with pethidine or buspirone, i.e., ritonavir, phenytoin, cimetidine, phenothiazines, opioids and partial opioid agonists (e.g., pentazocine, nalbuphine, buprenorphine)
  • Acute alcohol intoxication
  • Opioid addiction
  • Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential
  • Known hypersensitivity to the IMPs or any of their formulation ingredients
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  • Patient who is imprisoned or is lawfully kept in an institution
  • Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor
  • Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial
  • Prior participation in this trial
  • Any acutely life-threatening conditions other than acute ischaemic stroke
  • Rapidly resolving stroke symptoms
  • Evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis or any diagnosis likely to cause the present symptoms other than acute ischaemic stroke. Haemorrhagic transformation of the infarct is not an exclusion criterion, except when there is a parenchymal haematoma covering more than 30% of the infarcted area, with significant space-occupying effect, or when there is a bleeding remote from the infarcted area
  • Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis
  • SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration
  • Other severe respiratory disorder
  • Bradycardia (<40 bpm)
  • Severe cardiac failure, defined as NYHA classification ≥III
  • Myocardial infarction or angina pectoris in the 3 months prior to screening
  • Vasospastic disorders (e.g., Raynaud's disease)
  • Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia)
  • Known platelet count <100,000/mm3
  • Known INR >1.7
  • Skin damage (e.g., inflammation, burns, injuries, ulcerations, hives, rash) at the sites intended to be used for cooling
  • Clinical diagnosis of sepsis
  • Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN)
  • Known renal impairment (serum creatinine >2mg/100ml)
  • Addison's disease
  • Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia
  • Any condition that is thought to reduce the compliance to cooperate with the trial procedures

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Neurology, University Hospital Erlangen

    Erlangen, 91054

Other trials in Germany

About this study

Official title: EuroHYP-1: European Multicentre, Randomised, Phase III Clinical Trial of Therapeutic Hypothermia Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke

The purpose of this study is to determine if systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.

Being tested
Hypothermia, Buspirone, Pethidine
Keywords
acute ischemic stroke, hypothermia
Medical subject headings
Ischemic Stroke, Hypothermia

What participants receive

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

  • HypothermiaDevice

    Also called EMCOOLS Brain.Pad, Arctic Sun and ArcticGel Pads, CritiCool and CureWrap 3500, Zoll intravascular temperature management system

    In patients randomised to therapeutic hypothermia, induction of cooling will be started by infusion of 4°C isotone saline or Ringer's lactate administered over a period of 30 to 60 minutes. A body temperature between 34.0 and 35.0°C will be targeted. Body temperature will be monitored through bladder or rectal thermal probes, and cooling procedures will be adapted to keep body temperature as close as possible to the target. Maintenance of body temperature in the target range will be performed with a surface or endovascular cooling device. After a cooling period of 24h, controlled rewarming to 36°C with a rate of 0.2°C/h will be started. After 36°C have been reached, the device will be disconnected.

  • BuspironeDrug

    anti-shivering treatment

  • PethidineDrug

    anti-shivering treatment

Study groups in NCT01833312
Study groupRoleWhat they receive
HypothermiaExperimentalBest medical treatment + hypothermia 34-35°C for 24h
Receives: Device: Hypothermia; Drug: Buspirone; Drug: Pethidine
ControlNo interventionBest medical treatment

What is being measured

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

  1. modified Rankin scale

    Analysed with ordinal logistic regression and expressed as a common odds ratio.

    Measured: 3 months

Secondary outcomes (6)

  1. Mortality

    Measured: 3 months

  2. Neurological outcome

    NIHSS;

    World Health Organization Disability Assessment Schedule (WHODAS) 2.0

    Measured: 3 months

  3. Quality of life

    EuroQoL 5-dimensions 5-level questionnaire

    Measured: 3 months

  4. Cerebral infarct size

    Evaluated on CT or MRI imaging

    Measured: 48±24 hours

  5. Safety of systemic cooling

    Number of adverse events and severe adverse events related to the procedure of systemic cooling including induction, maintenance of hypothermia, rewarming, or the administration of anti-shivering medication (pethidine and buspirone) within the first 36h of enrollment.

    Number of adverse events and severe adverse events until outcome assessment at day 91.

    Measured: Enrollment - day 91

  6. Tolerability of systemic cooling

    Timing and dose of anti-shivering medication.

    Bedside shivering assessment scale (BSAS).

    Measured: 36 hours

Timeline

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

  1. First posted16 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Why it stopped: Slow recruitment, cessation of funding

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01833312
Sponsor's protocol ID
EuroHYP-1
Acronym
EuroHYP-1
Status last verified
Sep 2019
First submitted
4 Apr 2013
Last updated
2 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Winkel P, Bath PM, Gluud C, Lindschou J, van der Worp HB, Macleod MR, Szabo I, Durand-Zaleski I, Schwab S; EuroHYP-1 trial investigators. Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke. Trials. 2017 Nov 29;18(1):573. doi: 10.1186/s13063-017-2302-z.

    PubMed 29187242

  • van der Worp HB, Macleod MR, Bath PM, Demotes J, Durand-Zaleski I, Gebhardt B, Gluud C, Kollmar R, Krieger DW, Lees KR, Molina C, Montaner J, Roine RO, Petersson J, Staykov D, Szabo I, Wardlaw JM, Schwab S; EuroHYP-1 investigators. EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke. Int J Stroke. 2014 Jul;9(5):642-5. doi: 10.1111/ijs.12294. Epub 2014 May 15.

    PubMed 24828363

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hypothermia, Buspirone and Pethidine in people with Acute Ischemic Stroke, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

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 10 inclusion and 30 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: stopped early, as of the sponsor's last update on 2 Oct 2019. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Slow recruitment, cessation of funding). Results are not available in the source record.

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?

modified Rankin scale (time frame: 3 months). 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 NCT01833312, which also lists 2 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 2 Oct 2019.

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