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    Clinical Trial Results:
    A RANDOMIZED, CONTROLLED, MULTICENTER PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FIBRIN SEALANT VH S/D 500 S-APR (TISSEEL) FOR HEMOSTASIS IN SUBJECTS UNDERGOING HEPATIC RESECTION

    Summary
    EudraCT number
    2010-018480-42
    Trial protocol
    DE  
    Global end of trial date
    26 Jul 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Nov 2017
    First version publication date
    08 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    550904
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01244425
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Baxter Healthcare Corporation
    Sponsor organisation address
    1 Baxter Parkway, Deerfield, United States, 60015
    Public contact
    Clinical Trials Disclosure Group, Baxter Healthcare Corporation, joe_archer@Baxter.com
    Scientific contact
    Clinical Trials Disclosure Group, Baxter Healthcare Corporation, joe_archer@Baxter.com
    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
    26 Jul 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jul 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of FS VH S/D 500 s-apr for hemostasis in subjects undergoing partial hepatic resection, as compared to a control arm treated by manual compression with a surgical gauze swab.
    Protection of trial subjects
    If no hemostasis occurred within 10 minutes of treatment, the surgeon was free to use other additional hemostatic measures (ie, rescue therapy) as he/she felt appropriate. In the same way, the surgeon was, at any time in the procedure, free to abort study participation if convinced that medical circumstances made it necessary.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Nov 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 95
    Worldwide total number of subjects
    95
    EEA total number of subjects
    95
    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)
    95
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were to undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy.

    Pre-assignment
    Screening details
    Subjects were evaluated for eligibility at screening within 21 days prior to surgery, and enrolled as soon as informed consent was obtained after meeting all inclusion and exclusion criteria. A total of 95 subjects were enrolled, 25 subjects were not randomized (23 were screen failures, 2 discontinued).

    Pre-assignment period milestones
    Number of subjects started
    95
    Number of subjects completed
    70

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screen failures: 23
    Reason: Number of subjects
    Operated by non-investigator: 1
    Reason: Number of subjects
    Prolonged operation and IP could not be used: 1
    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    FS VH S/D 500 s-apr
    Arm description
    Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), sprayed onto the oozing resection surface of the liver, not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Fibrin Sealant (FS) VH S/D 500 s-apr
    Investigational medicinal product code
    Other name
    Tisseel
    Pharmaceutical forms
    Sealant
    Routes of administration
    Topical use
    Dosage and administration details
    Single application, sprayed onto the oozing resection surface of the liver, not to exceed 20mL.

    Arm title
    Manual Compression
    Arm description
    A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    FS VH S/D 500 s-apr Manual Compression
    Started
    35
    35
    Completed
    32
    32
    Not completed
    3
    3
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    2
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline period represents subjects randomized into study, and included in both the Full Analysis Set (FAS) and Safety populations. Worldwide number reflects total number enrolled including those not randomized and those who did not receive treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FS VH S/D 500 s-apr
    Reporting group description
    Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), sprayed onto the oozing resection surface of the liver, not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

    Reporting group title
    Manual Compression
    Reporting group description
    A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

    Reporting group values
    FS VH S/D 500 s-apr Manual Compression Total
    Number of subjects
    35 35 70
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.7 ± 14.5 59.8 ± 12.8 -
    Gender categorical
    Units: Subjects
        Female
    15 16 31
        Male
    20 19 39

    End points

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    End points reporting groups
    Reporting group title
    FS VH S/D 500 s-apr
    Reporting group description
    Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), sprayed onto the oozing resection surface of the liver, not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

    Reporting group title
    Manual Compression
    Reporting group description
    A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

    Primary: Percentage of participants with intraoperative hemostasis at 4 minutes after application of the randomized treatment

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    End point title
    Percentage of participants with intraoperative hemostasis at 4 minutes after application of the randomized treatment
    End point description
    Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: - No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the “time to hemostasis” was used; a time window of +5 seconds was acceptable for showing a success) - Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required - Reapplication of FS VH S/D 500 s-apr after 4 minutes - Intraoperative rebleeding after the first 4 minutes of the observation period
    End point type
    Primary
    End point timeframe
    4 minutes post start of treatment application
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: percentage of participants
        number (confidence interval 95%)
    82.9 (68.3 to 92.8)
    37.1 (22.5 to 53.6)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    likelihood-ratio chi square test
    Confidence interval

    Secondary: Percentage of participants with intraoperative hemostasis at 6 minutes after application of the randomized treatment

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    End point title
    Percentage of participants with intraoperative hemostasis at 6 minutes after application of the randomized treatment
    End point description
    Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
    End point type
    Secondary
    End point timeframe
    6 minutes after start of treatment application
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: percentage of participants
        number (confidence interval 95%)
    91.4 (79.3 to 97.8)
    57.1 (40.7 to 72.6)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    likelihood ratio chi-square test
    Confidence interval

    Secondary: Percentage of participants with intraoperative hemostasis at 8 minutes after application of the randomized treatment

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    End point title
    Percentage of participants with intraoperative hemostasis at 8 minutes after application of the randomized treatment
    End point description
    Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
    End point type
    Secondary
    End point timeframe
    8 minutes after start of treatment application
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: percentage of participants
        number (confidence interval 95%)
    91.4 (79.3 to 97.8)
    71.4 (55.3 to 84.5)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.028
    Method
    likelihood ratio chi-square test
    Confidence interval

    Secondary: Percentage of participants with intraoperative hemostasis at 10 minutes after application of the randomized treatment

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    End point title
    Percentage of participants with intraoperative hemostasis at 10 minutes after application of the randomized treatment
    End point description
    Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
    End point type
    Secondary
    End point timeframe
    10 minutes after start of treatment application
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: percentage of participants
        number (confidence interval 95%)
    94.3 (83.4 to 99.0)
    74.3 (58.4 to 86.7)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.017
    Method
    likelihood ratio chi-square test
    Confidence interval

    Secondary: Percentage of participants with intraoperative rebleeding after occurrence of hemostasis

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    End point title
    Percentage of participants with intraoperative rebleeding after occurrence of hemostasis
    End point description
    Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.
    End point type
    Secondary
    End point timeframe
    Intraoperative day 0
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: percentage of participants
        number (confidence interval 95%)
    2.9 (0.2 to 12.0)
    8.6 (2.2 to 20.7)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.293
    Method
    likelihood ratio chi-square test
    Confidence interval

    Secondary: Percentage of participants with postoperative rebleeding

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    End point title
    Percentage of participants with postoperative rebleeding
    End point description
    Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration
    End point type
    Secondary
    End point timeframe
    Day 0 Postoperative until discharged from surgical ward (within 48 hours after end of surgery or longer)
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: Percentage of participants
        number (confidence interval 95%)
    2.9 (0.1 to 14.9)
    0.0 (0.0 to 10.0)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.237
    Method
    likelihood ratio chi-square test
    Confidence interval

    Secondary: Percentage of participants with transfusion requirements until discharged from surgical ward

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    End point title
    Percentage of participants with transfusion requirements until discharged from surgical ward
    End point description
    Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.
    End point type
    Secondary
    End point timeframe
    Day ) Intra- and Postoperative until discharged from surgical ward (within 48 hours after end of surgery or longer)
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    35
    35
    Units: percentage of participants
        number (confidence interval 95%)
    40.0 (24.9 to 56.5)
    42.9 (27.4 to 59.3)
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    FS VH S/D 500 s-apr v Manual Compression
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.808
    Method
    likelihood ratio chi-square test
    Confidence interval

    Secondary: Median total volume of postoperative drainage fluid within 48 hours after surgery

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    End point title
    Median total volume of postoperative drainage fluid within 48 hours after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Within 48 hours after surgery
    End point values
    FS VH S/D 500 s-apr Manual Compression
    Number of subjects analysed
    32
    31
    Units: mL
        median (full range (min-max))
    415.0 (70 to 10800)
    410.0 (0 to 3690)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening (within 21 days prior to surgery) through end of study (20-40 days after surgery)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    unspecific
    Reporting groups
    Reporting group title
    FS VH S/D 500 s-apr
    Reporting group description
    -

    Reporting group title
    Manual Compression
    Reporting group description
    -

    Serious adverse events
    FS VH S/D 500 s-apr Manual Compression
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 35 (25.71%)
    11 / 35 (31.43%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    4 / 35 (11.43%)
    3 / 35 (8.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small-for-size liver syndrome
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (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
    Aspiration
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (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
    Multi-organ failure
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Portal vein thrombosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Liver abscess
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 35 (8.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdiaphragmatic abscess
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (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: 5%
    Non-serious adverse events
    FS VH S/D 500 s-apr Manual Compression
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 35 (62.86%)
    23 / 35 (65.71%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 35 (5.71%)
         occurrences all number
    3
    2
    Hypotension
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Chemical peritonitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Operative Haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 35 (8.57%)
         occurrences all number
    1
    3
    Pneumothorax traumatic
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Post procedural haematoma
         subjects affected / exposed
    4 / 35 (11.43%)
    2 / 35 (5.71%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    7 / 35 (20.00%)
    9 / 35 (25.71%)
         occurrences all number
    9
    14
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 35 (8.57%)
         occurrences all number
    1
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 35 (8.57%)
         occurrences all number
    1
    3
    Pyrexia
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 35 (11.43%)
         occurrences all number
    1
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    5 / 35 (14.29%)
    2 / 35 (5.71%)
         occurrences all number
    5
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    5 / 35 (14.29%)
         occurrences all number
    1
    5
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 35 (11.43%)
         occurrences all number
    2
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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