Cooling Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke (EuroHYP-1)
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ClinicalTrials.gov Identifier: NCT01833312 |
Recruitment Status :
Terminated
(Slow recruitment, cessation of funding)
First Posted : April 16, 2013
Last Update Posted : October 2, 2019
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Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
Tracking Information | ||||
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First Submitted Date ICMJE | April 4, 2013 | |||
First Posted Date ICMJE | April 16, 2013 | |||
Last Update Posted Date | October 2, 2019 | |||
Study Start Date ICMJE | July 2013 | |||
Actual Primary Completion Date | July 31, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
modified Rankin scale [ Time Frame: 3 months ] Analysed with ordinal logistic regression and expressed as a common odds ratio.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | Cooling Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Ischemic Stroke | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
98 | |||
Original Estimated Enrollment ICMJE |
1500 | |||
Actual Study Completion Date ICMJE | July 31, 2018 | |||
Actual Primary Completion Date | July 31, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01833312 | |||
Other Study ID Numbers ICMJE | EuroHYP-1 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University of Erlangen-Nürnberg Medical School | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Erlangen-Nürnberg Medical School | |||
Verification Date | September 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |