Suspended
EuroHYP-1EuroHYP-1: European Multicentre, Randomised, Phase III Clinical Trial of Therapeutic Hypothermia Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke
What is being tested
Hypothermia
+ Buspirone
+ Pethidine
DeviceDrug
Who is being recruted
Body Temperature Changes+9
+ Brain Diseases
+ Cardiovascular Diseases
Over 18 Years
+40 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: July 2013
Summary
Principal SponsorUniversity of Erlangen-Nürnberg Medical School
Last updated: October 2, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity of Erlangen-Nürnberg Medical School
Last updated: October 2, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
98 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Body Temperature ChangesBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesStrokeIschemic StrokeHypothermia
Criteria
10 inclusion criteria required to participate
Diagnosis of acute ischaemic stroke
Estimated body weight of 50 up to and including 120kg
GCS motor response subscale score >= 5
NIHSS score >= 6
Show More Criteria
30 exclusion criteria prevent from participating
Acute alcohol intoxication
Addison's disease
Any acutely life-threatening conditions other than acute ischaemic stroke
Any condition that is thought to reduce the compliance to cooperate with the trial procedures
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalBest medical treatment + hypothermia 34-35°C for 24h
Group II
No InterventionBest medical treatment
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Neurology, University Hospital Erlangen
Erlangen, GermanyOpen Department of Neurology, University Hospital Erlangen in Google MapsSuspendedOne Study Center