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    Clinical Trial Results:
    A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant(FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis.

    Summary
    EudraCT number
    2005-000889-39
    Trial protocol
    GB  
    Global end of trial date
    29 Mar 2006

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Aug 2016
    First version publication date
    05 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    400-05-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00154141
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ethicon Inc., a Johnson & Johnson Co.
    Sponsor organisation address
    Route 22 West, Somerville, United States,
    Public contact
    Jonathan Batiller, Ethicon Inc., a Johnson & Johnson Co., 1 9082182492, jbatill2@its.jnj.com
    Scientific contact
    Jonathan Batiller, Ethicon Inc., a Johnson & Johnson Co., 1 9082182492, jbatill2@its.jnj.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
    11 Apr 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate whether the fibrin sealant (FS2) reduces time to haemostasis during vascular surgical procedure on an end-to-side femoral or upper extremity arterial anastomosis utilising uncoated or heparin-coated polytetrafluoroethylene (PTFE) compared to manual compression (MC). Success rate of the FS2 group will be compared to success rate of the Manual Compression group. Success will be defined as the absence of bleeding at 4 minutes following randomisation.
    Protection of trial subjects
    The protocol and consent form were provided to the appropriate Ethics Committee for approval.
    Background therapy
    Not applicable
    Evidence for comparator
    Manual compression was used as a comparator. Traditionally suture hole bleeding was managed by compression with surgical swabs and reversal of heparin.
    Actual start date of recruitment
    09 Jun 2005
    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
    United States: 102
    Country: Number of subjects enrolled
    United Kingdom: 45
    Worldwide total number of subjects
    147
    EEA total number of subjects
    45
    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)
    58
    From 65 to 84 years
    86
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    The first subject was randomized 09-Jun-2005 and the last subject completed 29-Mar-2006. Patients were recruited from UK and US sites.

    Pre-assignment
    Screening details
    Prospective subjects were screened within 21 days prior to surgery. Prior to any study-related procedures being undertaken subjects were fully informed of all aspects of the study including the benefits, risks and constraints of the study and asked to sign a consent form.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    No blinding

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    FS2 product
    Arm description
    FS2
    Arm type
    Experimental

    Investigational medicinal product name
    FS2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sealant
    Routes of administration
    Topical use
    Dosage and administration details
    One FS2 kit contained the two components in separate vials (2 x 2 ml). The two components were: • Biological Active Component 2 (BAC2), comprising human fibrinogen 55-85 mg/ml • Thrombin comprising human thrombin 800-1200 IU/ml and calcium chloride 5.6-6.2 mg/ml. For each patient, one kit of FS2 (2 ml each of BAC2 and Thrombin [total 4 ml]) was pre-prepared for administration prior to randomisation and was administered by dripping onto the study anastomotic site (SAS).

    Arm title
    Manual compression
    Arm description
    Manual compression
    Arm type
    Manual compression

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    FS2 product Manual compression
    Started
    75
    72
    Completed
    73
    69
    Not completed
    2
    3
         Adverse event, serious fatal
    1
    1
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FS2 product
    Reporting group description
    FS2

    Reporting group title
    Manual compression
    Reporting group description
    Manual compression

    Reporting group values
    FS2 product Manual compression Total
    Number of subjects
    75 72 147
    Age categorical
    Units: Subjects
        < 50 years
    5 13 18
        50-64 years
    27 13 40
        65-74 years
    26 27 53
        >=75 years
    17 19 36
    Gender categorical
    Units: Subjects
        Female
    34 36 70
        Male
    41 36 77

    End points

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    End points reporting groups
    Reporting group title
    FS2 product
    Reporting group description
    FS2

    Reporting group title
    Manual compression
    Reporting group description
    Manual compression

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) comprised all randomised subjects (equivalent to the intent-to-treat (ITT) set).

    Primary: Absence of bleeding at SAS 4 minutes following randomisation

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    End point title
    Absence of bleeding at SAS 4 minutes following randomisation
    End point description
    Absence of bleeding at SAS 4 minutes following randomisation
    End point type
    Primary
    End point timeframe
    4 minutes following randomisation
    End point values
    FS2 product Manual compression Full Analysis Set (FAS)
    Number of subjects analysed
    75
    72
    147
    Units: Absence of bleeding
    64
    28
    147
    Statistical analysis title
    Primary efficacy endpoint
    Comparison groups
    Manual compression v FS2 product
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.001
    Method
    logistic model
    Parameter type
    Odds ratio (OR)
    Point estimate
    11.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.7
         upper limit
    27.5

    Secondary: Absence of bleeding at SAS 7 minutes following randomisation

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    End point title
    Absence of bleeding at SAS 7 minutes following randomisation
    End point description
    Absence of bleeding at SAS 7 minutes following randomisation
    End point type
    Secondary
    End point timeframe
    7 minutes following randomisation
    End point values
    FS2 product Manual compression
    Number of subjects analysed
    75
    72
    Units: Absence of bleeding
    68
    43
    Statistical analysis title
    secondary endpoint analysis
    Comparison groups
    FS2 product v Manual compression
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.001
    Method
    logistics model
    Parameter type
    Log odds ratio
    Point estimate
    7.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.8
         upper limit
    21.9

    Secondary: Absence of bleeding at SAS 10 minutes following randomisation

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    End point title
    Absence of bleeding at SAS 10 minutes following randomisation
    End point description
    Absence of bleeding at SAS 10 minutes following randomisation
    End point type
    Secondary
    End point timeframe
    10 minutes following randomisation
    End point values
    FS2 product Manual compression
    Number of subjects analysed
    75
    72
    Units: Absence of bleeding
    72
    50
    Statistical analysis title
    Secondary Endpoint Analysis
    Comparison groups
    FS2 product v Manual compression
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.001
    Method
    logistic model
    Parameter type
    Log odds ratio
    Point estimate
    18.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.7
         upper limit
    91.8

    Secondary: Incidence of potential bleeding related complications

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    End point title
    Incidence of potential bleeding related complications
    End point description
    Incidence of potential bleeding related complications
    End point type
    Secondary
    End point timeframe
    5 weeks post surgery (+/- 7 days
    End point values
    FS2 product Manual compression
    Number of subjects analysed
    75
    72
    Units: bleeding related complications
    12
    15
    Statistical analysis title
    Secondary endpoint
    Statistical analysis description
    Potential bleeding related complications
    Comparison groups
    FS2 product v Manual compression
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.426
    Method
    Logistic model
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    3.7

    Secondary: Incidence of treatment failure.

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    End point title
    Incidence of treatment failure.
    End point description
    Incidence of treatment failure.
    End point type
    Secondary
    End point timeframe
    5 weeks post surgery (+/- 7 days)
    End point values
    FS2 product Manual compression
    Number of subjects analysed
    75
    72
    Units: treatment failure
    6
    23
    Statistical analysis title
    Secondary endpoint
    Statistical analysis description
    Incidence of treatment failure
    Comparison groups
    FS2 product v Manual compression
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.001
    Method
    Logistic model
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE's were collected from the start of the Baseline Visit throughout the hospital admission for the procedure and until completion of the 5-week Follow-up Visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    FS2 product
    Reporting group description
    FS2

    Reporting group title
    Manual compression
    Reporting group description
    Manual compression

    Serious adverse events
    FS2 product Manual compression
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 75 (30.67%)
    21 / 72 (29.17%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium tremens
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Vascular graft occlusion
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 75 (0.00%)
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         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
    Respiratory failure
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure chronic
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Localised infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (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
    1 / 75 (1.33%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Graft infection
         subjects affected / exposed
    3 / 75 (4.00%)
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (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
    FS2 product Manual compression
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 75 (64.00%)
    51 / 72 (70.83%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 75 (1.33%)
    5 / 72 (6.94%)
         occurrences all number
    1
    5
    Injury, poisoning and procedural complications
    Vascular graft occlusion
         subjects affected / exposed
    2 / 75 (2.67%)
    5 / 72 (6.94%)
         occurrences all number
    2
    5
    Graft thrombosis
         subjects affected / exposed
    5 / 75 (6.67%)
    0 / 72 (0.00%)
         occurrences all number
    6
    0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 75 (0.00%)
    5 / 72 (6.94%)
         occurrences all number
    0
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    5 / 72 (6.94%)
         occurrences all number
    0
    5
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    5 / 75 (6.67%)
    2 / 72 (2.78%)
         occurrences all number
    5
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 75 (2.67%)
    6 / 72 (8.33%)
         occurrences all number
    2
    6
    Constipation
         subjects affected / exposed
    2 / 75 (2.67%)
    5 / 72 (6.94%)
         occurrences all number
    2
    6
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    4 / 72 (5.56%)
         occurrences all number
    1
    4
    Graft infection
         subjects affected / exposed
    4 / 75 (5.33%)
    5 / 72 (6.94%)
         occurrences all number
    4
    5

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2005
    Amendment 2- Following an investigator meeting clarification was provided on exclusion criterion one, measuring of intra-operative blood loss at the SAS was removed, a smaller dose of heparin was required for subjects undergoing an upper extremity procedure and clarification was added regarding prohibiting the use of any other fibrin sealant.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 Sep 2005
    Recruitment into the study was temporarily suspended between Monday 26th September 2005 and Monday 10th October 2005 for reasons related to the CE-marked application device that is used to apply the Investigational Product. The company realized that there were two different productions of the vial connector of the application device . One production had two moulding holes and the other production did not. After a comprehensive analysis of the two vial connectors, the company concluded that there was no clinical or safety impact from the variation.
    10 Oct 2005

    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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