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    Clinical Trial Results:
    Prevention by HMGCoA reductase inhibition of ALI associated with one lung ventilation following oesophagectomy by a Reduction of Pulmonary vascular dysfunction and inflammation (Prevention-HARP)

    Summary
    EudraCT number
    		 2007-002454-37
    Trial protocol
    		 GB  
    Global end of trial date
    10 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2020
    First version publication date
    08 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RGHT000392
    Additional study identifiers
    ISRCTN number
    		 ISRCTN56543987
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Belfast Health & Social Care Trust (BHSCT)
    Sponsor organisation address
    King Edward Building, Royal Hospitals, Grosvenor Road,, Belfast, United Kingdom,
    Public contact
    Prof Daniel McAuley, Queen's University of Belfast, 02890 976385, d.f.mcauley@qub.ac.uk
    Scientific contact
    Prof Daniel McAuley, Queen's University of Belfast, 02890 976385, d.f.mcauley@qub.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
    10 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The hypothesis of the study is that treatment with simvastatin can prevent lung injury and inflammation in humans undergoing oesophagectomy as assessed by important surrogate clinical outcomes. The primary outcome is to evaluate the efficacy of simvastatin to improve pulmonary vascular function between the simvastatin and placebo treated groups
    Protection of trial subjects
    A Clinical Trials Monitor monitored study site compliance with study and CTU SOPs and provided feedback on any actual or potential problems in relation to safeguarding patients safety and wellbeing. A DMEC was appointed comprising two clinicians with experience in undertaking clinical trials / caring for critically ill patients and a statistician. The DMEC met regularly and meetings were formally minuted. The DMEC’s responsibility was to safeguard the interests of the trial participants, in particular with regard to safety. The DMEC monitored recruitment and adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Aug 2007
    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: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    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)
    22
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 102 patients, who were due to undergo esophagectomy, were assessed for eligibility between July 2007 and July 2010. 39 patients fulfilled the eligibility criteria and were enrolled into the trial.

    Pre-assignment
    Screening details
    		 Inclusion criteria Adult patients undergoing oesophagectomy for oesophageal cancer at the Royal Victoria Hospital, Belfast (RVH) were eligible for inclusion in the study. Patients were identified prior to surgery at the oesophageal cancer multi-disciplinary meeting.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Simvastatin 80 mg or placebo (1:1) were encapsulated and in identical containers to ensure blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Simvastatin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simvastatin
    Investigational medicinal product code
    Other name
    Simvastatin
    Pharmaceutical forms
    Capsule
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    Simvastatin 80mg for 4 days preoperatively and for 7 days postoperatively.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    For 4 days pre-operatively and 7 days post-operatively.

    Number of subjects in period 1
    		Simvastatin Placebo
    Started
    19
    20
    Completed
    15
    16
    Not completed
    4
    4
         no surgery
    4
    4

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Simvastatin Placebo Total
    Number of subjects
    		 19 20 39
    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)
    		 10 12 22
        From 65-84 years
    		 9 8 17
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 11.5 ) 64.6 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 10
        Male
    		 15 14 29
    Smoking
    Units: Subjects
        Yes
    		 3 6 9
        Ex-smoker
    		 10 11 21
        No
    		 6 3 9
    Preoperative chemotherapy
    Units: Subjects
        yes
    		 15 14 29
        no
    		 4 6 10
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 28.2 ( 5.2 ) 26.6 ( 5.5 ) -

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: pulmonary dead space (Vd/Vt) at 6 hours

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    End point title
    		 pulmonary dead space (Vd/Vt) at 6 hours
    End point description
    End point type
    Primary
    End point timeframe
    at 6 hours following oesophagectomy or prior to extubation
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: Vd/Vt
        arithmetic mean (standard deviation)
    0.45 ( 0.09 )
    0.49 ( 0.08 )
    Statistical analysis title
    		 Deadspace at 6 hours t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Compliance

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    End point title
    		 Compliance
    End point description
    End point type
    Secondary
    End point timeframe
    at 6 hours following one lung ventilation or prior to extubation if earlier
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    42 ( 9 )
    42 ( 9 )
    Statistical analysis title
    		 Compliance t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: PaO2/FiO2 ratio

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    End point title
    		 PaO2/FiO2 ratio
    End point description
    End point type
    Secondary
    End point timeframe
    following oesophagectomy
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: ratio
        arithmetic mean (standard deviation)
    40 ( 14 )
    41 ( 14 )
    Statistical analysis title
    		 PaO2/FiO2 ratio t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Aspartate aminotransferase at day 4

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    End point title
    		 Safety Profile - Aspartate aminotransferase at day 4
    End point description
    End point type
    Secondary
    End point timeframe
    at day 4
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: units/L
        arithmetic mean (standard deviation)
    42 ( 6 )
    44 ( 6 )
    Statistical analysis title
    		 Aspartate aminotransferase Day 4 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Aspartate aminotransferase at day 11

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    End point title
    		 Safety Profile - Aspartate aminotransferase at day 11
    End point description
    End point type
    Secondary
    End point timeframe
    at day 11
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: units/L
        arithmetic mean (standard deviation)
    28 ( 2 )
    29 ( 2 )
    Statistical analysis title
    		 Aspartate aminotransferase day 11 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Alanine aminotransferase day 4

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    End point title
    		 Safety Profile - Alanine aminotransferase day 4
    End point description
    End point type
    Secondary
    End point timeframe
    at day 4
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: units/L
        arithmetic mean (standard deviation)
    40 ( 12 )
    30 ( 12 )
    Statistical analysis title
    		 Alanine aminotransferase day 4 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Alanine aminotransferase day 11

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    End point title
    		 Safety Profile - Alanine aminotransferase day 11
    End point description
    End point type
    Secondary
    End point timeframe
    at day 11
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: units/L
        arithmetic mean (standard deviation)
    34 ( 3 )
    33 ( 3 )
    Statistical analysis title
    		 Alanine aminotransferase day 11 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Creatine kinase at day 4

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    End point title
    		 Safety Profile - Creatine kinase at day 4
    End point description
    End point type
    Secondary
    End point timeframe
    at day 4
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: units/L
        arithmetic mean (standard deviation)
    726 ( 104 )
    1067 ( 104 )
    Statistical analysis title
    		 Creatine kinase day 4 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Creatine kinase at day 11

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    End point title
    		 Safety Profile - Creatine kinase at day 11
    End point description
    End point type
    Secondary
    End point timeframe
    at day 11
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: units/L
        arithmetic mean (standard deviation)
    161 ( 27 )
    162 ( 25 )
    Statistical analysis title
    		 Creatine kinase day 11 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Creatinine at day 4

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    End point title
    		 Safety Profile - Creatinine at day 4
    End point description
    End point type
    Secondary
    End point timeframe
    at day 4
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: μmol/L
        arithmetic mean (standard deviation)
    70 ( 3 )
    66 ( 3 )
    Statistical analysis title
    		 Creatinine day 4 t-test
    Comparison groups
    Placebo v Simvastatin
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Safety Profile - Creatinine at day 11

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    End point title
    		 Safety Profile - Creatinine at day 11
    End point description
    End point type
    Secondary
    End point timeframe
    at day 11
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: μmol/L
        arithmetic mean (standard deviation)
    61 ( 4 )
    62 ( 4 )
    Statistical analysis title
    		 Creatinine day 11 t-test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 t-test, 2-sided
    Confidence interval

    Other pre-specified: Plasma Rage- D0 pre-OLV

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    End point title
    		 Plasma Rage- D0 pre-OLV
    End point description
    End point type
    Other pre-specified
    End point timeframe
    D0 pre-OLV
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: (pg/mL)
        arithmetic mean (standard deviation)
    1746 ( 1130 )
    2306 ( 2039 )
    Statistical analysis title
    		 Plasma Rage D0 pre-OLV 2-way ANOVA
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.02
    Method
    		 ANOVA
    Confidence interval

    Other pre-specified: Plasma Rage D0 post-OLV

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    End point title
    		 Plasma Rage D0 post-OLV
    End point description
    End point type
    Other pre-specified
    End point timeframe
    D0 post-OLV
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: (pg/mL)
        arithmetic mean (standard deviation)
    1576 ( 909 )
    2546 ( 2465 )
    Statistical analysis title
    		 Plasma Rage D0 post-OLV 2-way ANOVA
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.02
    Method
    		 ANOVA
    Confidence interval

    Other pre-specified: Plasma Rage Day 3

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    End point title
    		 Plasma Rage Day 3
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 3
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: (pg/mL)
        arithmetic mean (standard deviation)
    1049 ( 845 )
    1541 ( 1413 )
    Statistical analysis title
    		 Plasma Rage Day 3 2-way ANOVA
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.02
    Method
    		 ANOVA
    Confidence interval

    Other pre-specified: Plasma Rage Day 7

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    End point title
    		 Plasma Rage Day 7
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 7
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: (pg/mL)
        arithmetic mean (standard deviation)
    806 ( 599 )
    1656 ( 3069 )
    Statistical analysis title
    		 Plasma Rage Day 3 2-way ANOVA
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.02
    Method
    		 ANOVA
    Confidence interval

    Other pre-specified: Hospital Outcomes - ALI

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    End point title
    		 Hospital Outcomes - ALI
    End point description
    End point type
    Other pre-specified
    End point timeframe
    until discharge
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: subjects
        Yes
    0
    4
        No
    15
    12
    Statistical analysis title
    		 Hospital Outcome ALI Fisher exact test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Fisher exact
    Confidence interval

    Other pre-specified: Hospital Outcomes - Complications

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    End point title
    		 Hospital Outcomes - Complications
    End point description
    End point type
    Other pre-specified
    End point timeframe
    until discharge
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: subjects
        Cardiac
    3
    5
        Respiratory
    3
    8
        Infective
    1
    2
    Statistical analysis title
    		 Complications Fisher exact test
    Statistical analysis description
    cardiac, respiratory and infective complications
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29
    Method
    		 Fisher exact
    Confidence interval

    Other pre-specified: Hospital Outcomes - ICU readmission

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    End point title
    		 Hospital Outcomes - ICU readmission
    End point description
    End point type
    Other pre-specified
    End point timeframe
    until discharge
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: subjects
        Yes
    1
    4
        No
    14
    12
    Statistical analysis title
    		 Hospital Outcomes- ICU readmission Fisher exact
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 Fisher exact
    Confidence interval

    Other pre-specified: Hospital Outcome Total Ventilator Days

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    End point title
    		 Hospital Outcome Total Ventilator Days
    End point description
    End point type
    Other pre-specified
    End point timeframe
    until discharge
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: Days
        arithmetic mean (standard deviation)
    1 ( 0 )
    5 ( 8 )
    Statistical analysis title
    		 Hospital Outcomes- Total Ventilator Days
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 t-test, 2-sided
    Confidence interval

    Other pre-specified: Hospital Outcomes- Total Hospital Stay

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    End point title
    		 Hospital Outcomes- Total Hospital Stay
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Until discharge
    End point values
    		 Simvastatin Placebo
    Number of subjects analysed
    15
    16
    Units: Days
        arithmetic mean (standard deviation)
    22 ( 17 )
    33 ( 33 )
    Statistical analysis title
    		 Hospital Outcome- Total Hospital Stay t test
    Comparison groups
    Simvastatin v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to day 7
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC AE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Simvastatin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Simvastatin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
    6 / 16 (37.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Obstruction gastric
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute lung injury
         subjects affected / exposed
    0 / 15 (0.00%)
    4 / 16 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 16 (18.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Simvastatin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    15 / 16 (93.75%)
    Investigations
    Increased creatine phosphokinase
         subjects affected / exposed
    15 / 15 (100.00%)
    14 / 16 (87.50%)
         occurrences all number
    15
    14
    Investigation abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 15 (13.33%)
    5 / 16 (31.25%)
         occurrences all number
    2
    5
    Pleural effusion
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Infections and infestations
    Wound infection
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2007
    In the event of delay and postponement of the surgery the study medication will be stopped and then restarted 4 days prior to the new date of surgery. Above info added to intervention section 3.3 of protocol

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23817506
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