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    Clinical Trial Results:
    Comparison between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes following Cardiac Surgery - a Randomised Controlled Feasibility Trial

    Summary
    EudraCT number
    		 2019-000171-16
    Trial protocol
    		 GB  
    Global end of trial date
    11 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2026
    First version publication date
    03 May 2026
    Other versions
    Summary report(s)
    		 COPIA CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    KCH-PRO:19/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE1 9RT
    Public contact
    Dr Gudrun Kunst, King's College Hospital NHS Foundation Trust, 44 02032993154 , gudrun.kunst@kcl.ac.uk
    Scientific contact
    Dr Gudrun Kunst, King's College Hospital NHS Foundation Trust, 44 02032993154 , gudrun.kunst@kcl.ac.uk
    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
    16 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the COPIA feasibility trial is to determine feasibility of the proposed multicentre study: 1. Determination of the likely rate of recruitment at two centres. 2. Identification of potential recruitment barriers with current protocol.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAEs, SUSARs, protocol violations, cure, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawals can render the study un-interpretable; therefore, unnecessary withdrawal of patients should be avoided. Should a patient decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible. Should a patient withdraw from study drug only, efforts will be made to continue to obtain follow-up data, with the permission of the patient. A patient may decide to withdraw from the trial at any time without prejudice to their future care.
    Background therapy
    		 Myocardial revascularisation and cardiopulmonary bypass (CPB) can cause ischaemia-reperfusion injury, leading to myocardial and other end-organ damage. Volatile anaesthetics protect the myocardium in experimental studies. However, there is uncertainty about whether this translates into clinical benefits because of the coadministration of propofol and its detrimental effects, restricting myocardial protective processes. In summary, the proposed feasibility trial will, for the first time, compare volatile anaesthetics as the only anaesthetic agent (without propofol), with the administration of propofol only for maintenance of anaesthesia and investigate meaningful clinical outcomes. The results of the feasibility trial will be used to assess whether it is clinically acceptable and achievable to compare propofol anaesthesia with inhalational anaesthesia as the induction and maintenance agent during cardiac surgery.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2019
    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
    United Kingdom: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    0
    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)
    15
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 416 [1]
    Number of subjects completed
    		 50

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Ineligible: 308
    Reason: Number of subjects
    		 Eligible but declined consent: 58
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screening participants as enrolled
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Staff at each site, and at the LSHTM CTU, will be arranged into blinded and unblinded teams. This will be recorded in the delegation log at each organisation. For the duration of the trial, staff may move from the blinded team to the unblinded team, but not from the unblinded team to the blinded team.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Volatile group
    Arm description
    		 Volatile anaesthetics, either isoflurane, sevoflurane or desflurane, used for maintenance of anaesthesia. Administration via inhalation / ventilation through alveolar membrane in lungs. The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Volatile anaesthetic agents
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The volatile anaesthetic agent was administered via inhalation, i.e. ventilation through alveolar membrane in lungs, for induction and during the maintenance of anaesthesia. During CPB the volatile anaesthetic agent was administered through the oxygenator oxygen inflow of the CPB machine. The maintenance dose of the volatile anaesthetic agent was titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with an approximate BIS of 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist. The administration of the volatile anaesthetic agent was started with the induction of anaesthesia and ended at the end of surgery, before the patient transferred to the CCU.

    Arm title
    		 Propofol group
    Arm description
    		 Propofol, an intravenous anaesthetic used for maintenance of anaesthesia. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia without blood pressure.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Propofol was administered via an infusion. Patients received propofol only during the surgical procedure. The maintenance dose of the propofol infusion was titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with an approximate BIS of 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist.

    Number of subjects in period 1
    		Volatile group Propofol group
    Started
    25
    25
    Completed
    22
    22
    Not completed
    3
    3
         Consent withdrawn by subject
    -
    1
         Died before discharge
    1
    -
         Died after discharge
    1
    1
         Incomplete dataset
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 50 50
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 34 34
        85 years and over
    		 0 0
        Not recorded
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 38 38
        Not recorded
    		 1 1
    Ethnicity
    Units: Subjects
        White
    		 44 44
        Black
    		 1 1
        Asian
    		 2 2
        Missing data
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Volatile group
    Reporting group description
    		 Volatile anaesthetics, either isoflurane, sevoflurane or desflurane, used for maintenance of anaesthesia. Administration via inhalation / ventilation through alveolar membrane in lungs. The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure.

    Reporting group title
    Propofol group
    Reporting group description
    		 Propofol, an intravenous anaesthetic used for maintenance of anaesthesia. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia without blood pressure.

    Primary: Protocol adherence

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    End point title
    		 Protocol adherence [1]
    End point description
    End point type
    Primary
    End point timeframe
    From screening to 30-day follow-up
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Volatile group Propofol group
    Number of subjects analysed
    25
    25
    Units: protocol violations
        Not recorded
    1
    1
        Protocol violation
    0
    2
    No statistical analyses for this end point

    Secondary: Median time at the time point of the 30-day follow-up

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    End point title
    		 Median time at the time point of the 30-day follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    Surgery to 30-day follow-up
    End point values
    		 Volatile group Propofol group
    Number of subjects analysed
    22 [2]
    22 [3]
    Units: days
    arithmetic mean (full range (min-max))
        Median time
    33 (30 to 54)
    37.5 (31 to 49)
    Notes
    [2] - 1 patient did not have surgery, 1 patient died before discharge and 1 patient died after discharge
    [3] - 1 patient withdrew consent before surgery, 1 died after discharge, 1 had incomplete data set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From day of surgery to 30 days post-randomisation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not specified in CSR
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Volatile group
    Reporting group description
    		 -

    Reporting group title
    Propofol group
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: According to the CSR, there were no non-serious AEs. Please see report.
    Serious adverse events
    		 Volatile group Propofol group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Volatile group Propofol group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2020
    SA001 Protocol v2.0 22 January 2020
    23 Mar 2022
    SA002 RSI update

    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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