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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2012-002944-25
    Trial protocol
    ES   FI   IT   IE  
    Global end of trial date
    09 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2020
    First version publication date
    05 Feb 2020
    Other versions
    Summary report(s)
    Synopsis_annex1_ICH_E3

    Trial information

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    Trial identification
    Sponsor protocol code
    EuroHyp-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01833312
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Schwabachanlage 6, Erlangen, Germany,
    Public contact
    Direktion, Neurologische Klinik, Universitätsklinikum Erlangen, stefan.schwab@uk-erlangen.de
    Scientific contact
    Direktion, Neurologische Klinik, Universitätsklinikum Erlangen, stefan.schwab@uk-erlangen.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
    Protection of trial subjects
    Study participants assigned to the control group initially have their vital parameters closely monitored and also come to the study site once at the end of the follow-up phase for a final examination. The discomfort for these patients is classified as minimal; there are no study-related risks for these patients. For study participants assigned to therapeutic hypothermia by the randomisation process, the following control mechanisms and counter-measures have been implemented to minimise discomfort and risks. 1. Discomfort and shivering: Administration of pethidine and buspirone, if necessary increase in target body temperature or termination of hypothermia. 2. Opioid-induced Nausea: Administration of 5-HT3-receptor antagonists. 3. Pain from application of cooling catheter (endovascular cooling): Local anaesthesia at the puncture site, maximum 2 puncturing attempts. 4. Volume overload due to induction infusion (20 mL/kg BW): Exclusion criterion NYHA ≥III, if necessary administration of a diuretic. 5. Pneumonia: Antibiotic therapy, if necessary discontinuation of hypothermia.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    United Kingdom: 30
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    France: 22
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    98
    EEA total number of subjects
    98
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    25
    From 65 to 84 years
    73
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    1. Diagnosis of acute ischaemic stroke. 2. Possibility to start therapeutic hypothermia within 6 hours after onset of stroke. 3. mRS score ≤2 prior to onset of stroke. 4. NIHSS score ≥ 6. 5. No evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis

    Period 1
    Period 1 title
    Screening Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind [1]
    Roles blinded
    Assessor, Data analyst [2]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Hypothermia group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pethidine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Loading dose 50mg, subsequent doses 25mg, interval 30min minimum, maximum daily dose 500mg

    Arm title
    Control group
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to the nature of the intervention blinding of subject and site staff was not possible but assessor of the primary endpoint and data analyst were blinded.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the nature of the intervention blinding of subject and site staff was not possible but assessor of the primary endpoint and data analyst were blinded.
    Number of subjects in period 1
    Hypothermia group Control group
    Started
    49
    49
    Completed
    49
    49
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind [3]
    Roles blinded
    Data analyst, Assessor [4]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Hypothermia group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pethidine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Loading dose 50mg, subsequent doses 25mg, interval 30min minimum, maximum daily dose 500mg

    Investigational medicinal product name
    Buspirone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    loading dose 10mg, subsequent doses 10mg, maximum daily dose 30mg

    Arm title
    Control group
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [3] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to the nature of the intervention blinding of subject and site staff was not possible but assessor of the primary endpoint and data analyst were blinded.
    [4] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the nature of the intervention blinding of subject and site staff was not possible but assessor of the primary endpoint and data analyst were blinded.
    Number of subjects in period 2
    Hypothermia group Control group
    Started
    49
    49
    Completed
    49
    49
    Period 3
    Period 3 title
    Post-treatment period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind [5]
    Roles blinded
    Assessor, Data analyst [6]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Hypothermia group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pethidine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Loading dose 50mg, subsequent doses 25mg, interval 30min minimum, maximum daily dose 500mg

    Investigational medicinal product name
    Buspirone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    loading dose 10mg, subsequent doses 10mg, maximum daily dose 30mg

    Arm title
    Control group
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [5] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Due to the nature of the intervention blinding of subject and site staff was not possible but assessor of the primary endpoint and data analyst were blinded.
    [6] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the nature of the intervention blinding of subject and site staff was not possible but assessor of the primary endpoint and data analyst were blinded.
    Number of subjects in period 3
    Hypothermia group Control group
    Started
    49
    49
    Completed
    48
    46
    Not completed
    1
    3
         Lost to follow-up
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Hypothermia group
    Reporting group description
    -

    Reporting group title
    Control group
    Reporting group description
    -

    Reporting group values
    Hypothermia group Control group Total
    Number of subjects
    49 49 98
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    11 14 25
        From 65-84 years
    38 35 73
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    71.1 ± 12.0 69.6 ± 11.8 -
    Gender categorical
    Units: Subjects
        Female
    22 21 43
        Male
    27 28 55
    NIHSS >12
    at the time of enrollment
    Units: Subjects
        NIHSS >12
    21 19 40
        NIHSS <=12
    28 30 58

    End points

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    End points reporting groups
    Reporting group title
    Hypothermia group
    Reporting group description
    -

    Reporting group title
    Control group
    Reporting group description
    -
    Reporting group title
    Hypothermia group
    Reporting group description
    -

    Reporting group title
    Control group
    Reporting group description
    -
    Reporting group title
    Hypothermia group
    Reporting group description
    -

    Reporting group title
    Control group
    Reporting group description
    -

    Primary: Score on the mRS

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    End point title
    Score on the mRS
    End point description
    Distribution of subjects per mRS score
    End point type
    Primary
    End point timeframe
    Day 91±14 days
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    48
    46
    Units: number of subjects
        mRS 0
    3
    1
        mRS 1
    7
    6
        mRS 2
    14
    11
        mRS 3
    5
    9
        mRS 4
    4
    12
        mRS 5
    10
    3
        mRS 6
    5
    4
    Statistical analysis title
    mRS score
    Statistical analysis description
    Frequencies and percentages per mRS categories per intervention group are reported.
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.97
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.48
         upper limit
    2.13

    Secondary: Death or dependency, defined as a score on the mRS >2

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    End point title
    Death or dependency, defined as a score on the mRS >2
    End point description
    End point type
    Secondary
    End point timeframe
    Day 91±14 days
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    48
    46
    Units: number of subjects
    24
    28
    Statistical analysis title
    death or dependency
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.29
    Method
    Regression, Logistic
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    1.14

    Secondary: Death

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    End point title
    Death
    End point description
    End point type
    Secondary
    End point timeframe
    Day 91±14 days
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    48
    46
    Units: number of subjects
    5
    4
    Statistical analysis title
    death
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.73
    Method
    Regression, Logistic
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.34
         upper limit
    3.81

    Secondary: Score on NIHSS

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    End point title
    Score on NIHSS
    End point description
    End point type
    Secondary
    End point timeframe
    Day 91±14 days
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    45
    46
    Units: score
        median (inter-quartile range (Q1-Q3))
    3.0 (1.0 to 11.0)
    3.0 (1.0 to 8.0)
    Statistical analysis title
    score on NIHSS
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.39
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.26
         upper limit
    2.86

    Secondary: Brain infarct size

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    End point title
    Brain infarct size
    End point description
    End point type
    Secondary
    End point timeframe
    Hour 48±24 hours
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    45
    37
    Units: mm3
        median (inter-quartile range (Q1-Q3))
    37468 (13027 to 102760)
    34302 (10523 to 65460)
    Statistical analysis title
    Brain infarct size
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.55
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -14695
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -64212
         upper limit
    34823

    Secondary: WHODAS 2.0 score

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    End point title
    WHODAS 2.0 score
    End point description
    End point type
    Secondary
    End point timeframe
    Day 91±14 days
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    26
    27
    Units: score
        median (inter-quartile range (Q1-Q3))
    53.5 (5.8 to 86.5)
    38.0 (12.0 to 74.0)
    Statistical analysis title
    WHODAS 2.0 score
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.11
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -16.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -37.6
         upper limit
    3.75

    Secondary: EQ-5D-5L score

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    End point title
    EQ-5D-5L score
    End point description
    End point type
    Secondary
    End point timeframe
    Day 91±14 days
    End point values
    Hypothermia group Control group
    Number of subjects analysed
    44
    46
    Units: score
        median (inter-quartile range (Q1-Q3))
    70.0 (50.0 to 90.0)
    67.0 (50.0 to 80.0)
    Statistical analysis title
    EQ-5D-5L
    Comparison groups
    Hypothermia group v Control group
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.39
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.26
         upper limit
    2.86

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation for an AE extends from the time of patient enrolment until outcome assessment [A7, Day 91±14 days] or end of trial assessment [A8], respectively, has been performed.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Hypothermia group
    Reporting group description
    -

    Reporting group title
    Control group
    Reporting group description
    -

    Serious adverse events
    Hypothermia group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 49 (36.73%)
    14 / 49 (28.57%)
         number of deaths (all causes)
    5
    4
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Carotid endarterectomy
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    6 / 49 (12.24%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Stroke in evolution
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neurological symptom
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Impaired healing
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Sepsis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Hypothermia group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 49 (73.47%)
    30 / 49 (61.22%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 49 (0.00%)
         occurrences all number
    5
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 49 (0.00%)
         occurrences all number
    6
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    4 / 49 (8.16%)
    5 / 49 (10.20%)
         occurrences all number
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 49 (2.04%)
         occurrences all number
    7
    1
    Nervous system disorders
    Haemorrhagic transformation stroke
         subjects affected / exposed
    6 / 49 (12.24%)
    1 / 49 (2.04%)
         occurrences all number
    6
    1
    Headache
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
         occurrences all number
    4
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 49 (8.16%)
    4 / 49 (8.16%)
         occurrences all number
    6
    4
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 49 (4.08%)
         occurrences all number
    5
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 49 (16.33%)
    6 / 49 (12.24%)
         occurrences all number
    8
    7
    Nausea
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 49 (2.04%)
         occurrences all number
    5
    1
    Vomiting
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 49 (4.08%)
         occurrences all number
    5
    2
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 49 (8.16%)
         occurrences all number
    4
    4
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 49 (2.04%)
         occurrences all number
    4
    1
    Hypokalaemia
         subjects affected / exposed
    6 / 49 (12.24%)
    1 / 49 (2.04%)
         occurrences all number
    6
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 49 (4.08%)
         occurrences all number
    5
    2
    Urinary tract infection
         subjects affected / exposed
    7 / 49 (14.29%)
    3 / 49 (6.12%)
         occurrences all number
    8
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Mar 2014
    1. Prolongation of injection time span for 5-HT3 receptor antagonists 2. Surveillance of body temperature according to local practice 3. No surveillance of depth of sedation in regular time intervals 4. Hourly documentation of vital parameters 5. Permission of thrombolysis in other Hospital
    29 Jun 2015
    1. Reduction of cooling period from 24 hours to 12 hours 2. Extention of study population: NIHSS without upper limitation, permission of intravasal thrombectomy, time interval from start of thrombolysis to start of cooling from 90 to 150 minutes 3. Reduction of sample size (1500 -> 800)
    24 Jun 2016
    1. Prolongation of biomarker blood sampling by one hour 2. Introduction of 2 additional surface systems and 2 additional intravasal cooling catheters 3. Importation of buspirone from other EU member states in those member states where buspirone is no longer marketed

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Considerable shortfall of number of subjects recruited limits informative value of results
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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