Cooling Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke (EuroHYP-1)

University of Erlangen-Nürnberg Medical School

Status and phase

Terminated

Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: Pethidine

Device: Hypothermia

Drug: Buspirone

Study type

Interventional

Funder types

Other

Identifiers

NCT01833312

EuroHYP-1

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
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

Exclusion criteria

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
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