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    Clinical Trial Results:
    Prevention of bleeding and edema in bi-maxillary orthognathic surgery; the effectiveness of tranexamic acid on intraoperative bleeding in orthognathic surgery

    Summary
    EudraCT number
    		 2013-005473-52
    Trial protocol
    		 DK  
    Global end of trial date
    24 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Sep 2021
    First version publication date
    23 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    40964
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospital of South West Jutland
    Sponsor organisation address
    Finsensgade 35, Esbjerg, Denmark, 6700
    Public contact
    Kæbekirurgisk afd., Hospital of South West Jutland, +45 40269517, jesperjaredolsen@gmail.com
    Scientific contact
    Kæbekirurgisk afd., Hospital of South West Jutland, +45 40269517, jesperjaredolsen@gmail.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
    14 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is primarily to evaluate the effectiveness of tranexamic acid (TXA) on intraoperative blood loss - and secondarily postoperative swelling, in patients subjected to bi-maxillary orthognathic surgery. These surgical procedures are performed in anatomic areas rich in vessels, and intraoperative bleeding may pose a significant clinical problem. Tranexamic acid has been shown to significantly reduce intraoperative bleeding across the surgical fields, however within maxillofacial surgery few studies exist, and these are somewhat lacking in consistency and scope. Thus, the effect of TXA on intraoperative bleeding in patients subjected to simultaneous mandibular and maxillary osteotomy is uncertain and a carefully conducted, double-blinded, placebo controlled clinical study is needed.
    Protection of trial subjects
    A risk assessment of the potential study subjects was secured by Sponsor and appointed clinical staff prior to trial start through the application of the predetermined selection criteria. The trial was performed according to- and approved by the local Data Monitoring, Ethics Committee as well as the Good Clinical Practice unit in order to monitor and guide the overall progress while protecting the rights and safety of trial patients.As many blood samples as possible were obtained with the trial subjects in full anesthesia, in order to minimize the pain from the needle prick from the collection of venous blood.
    Background therapy
    		 All the study subjects recieved bi-maxillary corrective jaw surgery.
    Evidence for comparator
    		 Tranexamic acid has been shown to significantly reduce intraoperative bleeding across the surgical fields, however within maxillofacial surgery relatively few studies exist, and these are somewhat lacking in consistency and scope. Thus, the effect of TXA on intraoperative bleeding in patients subjected to simultaneous mandibular and maxillary osteotomy is uncertain and a carefully conducted, double-blinded, placebo controlled clinical study is needed.
    Actual start date of recruitment
    10 Mar 2014
    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
    Denmark: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    104
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This double-blinded placebo-controlled trial recruited patients eligible for orthognathic surgery of upper and lower jaw at the Hospital of South West Denmark (Esbjerg, Denmark) from August 2014 through October 2016.

    Pre-assignment
    Screening details
    		 One hundred and fifteen patients were screened for eligibility of which 104 were included of which 96 completed the trial according to protocol.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    The regional hospital pharmacy is responsible for the production of the randomization code and labels for test agents under GCP guidance prior to the start of the trial. During the trial the local hospital pharmacy is responsible for the preparation of the active drug and the placebo including marking the agent with the correct label according to the randomization code document.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 OS patients recieving the active drug consisting of 1 gram bolus intravenous administered tranexamic acid after the induction of general anesthesia
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tranexamic acid
    Investigational medicinal product code
    Other name
    TXA
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 gram bolus intravenous administered tranexamic acid

    Arm title
    		 Placebo
    Arm description
    		 OS patients recieving inactive placebo agent consisting of 1 gram bolus intravenous administered sterile saline after the induction of anesthesia
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiological saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    10 ml of physiologic, sterile saline were administered a single, slow i.v. bolus injection as the placebo treatment.

    Number of subjects in period 1
    		Intervention Placebo
    Started
    52
    52
    Completed
    51
    45
    Not completed
    1
    7
         Consent withdrawn by subject
    -
    1
         Protocol deviation
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 OS patients recieving the active drug consisting of 1 gram bolus intravenous administered tranexamic acid after the induction of general anesthesia

    Reporting group title
    Placebo
    Reporting group description
    		 OS patients recieving inactive placebo agent consisting of 1 gram bolus intravenous administered sterile saline after the induction of anesthesia

    Reporting group values
    		 Intervention Placebo Total
    Number of subjects
    		 52 52 104
    Age categorical
    Patients were aged between 18 and 53
    Units: Subjects
        Adults (18-64 years)
    		 52 52 104
    Gender categorical
    Units: Subjects
        Female
    		 25 26 51
        Male
    		 27 26 53

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 OS patients recieving the active drug consisting of 1 gram bolus intravenous administered tranexamic acid after the induction of general anesthesia

    Reporting group title
    Placebo
    Reporting group description
    		 OS patients recieving inactive placebo agent consisting of 1 gram bolus intravenous administered sterile saline after the induction of anesthesia

    Subject analysis set title
    3D facial scans
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    During the trial an amendment was added in order to measure the postoperative facial swelling in both groups. All other ananlyses incl. blood samples were the same as before the amendment. This results in to populations within the same study - a larger group which analyses the effect of tranexamic acid on bleeding, and a smaller group which concerns both bleeding ad swelling. Thus the 50 participants who are included with scans as well as bleeding measurements are contained in the larger population which pertains to "bleeding only" data. The active arm consisted of 16 males and 13 females and the placebo group consisted of 12males and 9 females. All of these were within same age category as the rest of the study subjects.

    Primary: Intraoperative bleeding

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    End point title
    		 Intraoperative bleeding
    End point description
    The primary outcome was intraoperative bleeding determined by milliliters of blood in the suction canister and gauzes deducted from the volume of saline used intraoperatively.
    End point type
    Primary
    End point timeframe
    Duration of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: millilitre(s)
        median (inter-quartile range (Q1-Q3))
    275 (143 to 408)
    403 (215 to 609)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Platelet count t5 according to intervention group

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    End point title
    		 Platelet count t5 according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    Measured five hours from start of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: Blood platelets/microlitre(s) of blood
        median (confidence interval 95%)
    206 (174 to 252)
    198 (169 to 265)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Hemoglobin at t5 according to intervention group

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    End point title
    		 Hemoglobin at t5 according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    Five hours after start of surgery.
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: gram(s)/millilitre
        arithmetic mean (confidence interval 95%)
    8.0 (7.4 to 8.8)
    7.9 (7.3 to 8.6)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.27
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Hematocrit at t5 according to intervention group

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    End point title
    		 Hematocrit at t5 according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    Five hours after start of surgery.
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: litre(s)/litre(s)
        median (inter-quartile range (Q1-Q3))
    0.39 (0.35 to 0.41)
    0.37 (0.35 to 0.4)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Postoperative swelling according to intervention group

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    End point title
    		 Postoperative swelling according to intervention group
    End point description
    Subjects were scanned in the DAVID-SLS-2 scanner (SLS-2) [DAVID Vision Systems GmbH, Koblenz, Germany] at 48 hours (t48h) and 4 months (t4 months) postoperatively. At 48 hours the POS was assumed to peak and at four months the majority of POS was expected to have subsided2 serving as the baseline measure for POS. As a consequence, POS is in the current work defined in terms of the difference t48h - t4 months. Subjects were seated with their heads slightly tilted back supported by a headrest, and with teeth in maximal intercuspidal position. No splints were used postoperatively. Three scans (A, B, C) were needed for a full-face scan consisting of A) a frontal scan perpendicular to the facial midline and B, C) bilateral scans spaced approximately 45-55° measured from the facial midline.
    End point type
    Secondary
    End point timeframe
    1st scanning is performed 48 hours postoperatively along with the 3rd blood sample. 2nd scanning is performed 4 months postoperatively along with the 4th blood sample.
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    29
    21
    Units: millimeter(s)
    arithmetic mean (standard deviation)
        1: Neck
    2.45 ( 4.14 )
    2.44 ( 3.07 )
        2: Chin
    1.67 ( 2.64 )
    1.92 ( 2.00 )
        3: Mouth
    2.76 ( 1.86 )
    3.27 ( 1.26 )
        4: Nose
    0.28 ( 0.76 )
    0.21 ( 0.46 )
        5: Eyes
    0.05 ( 0.49 )
    0.12 ( 0.54 )
        6: Forehead
    -0.13 ( 0.26 )
    -0.03 ( 0.18 )
        7: Cheek
    3.03 ( 1.39 )
    3.53 ( 1.29 )
    Attachments
    		 Untitled (Filename: Facial scans.pdf)
    Statistical analysis title
    		 Point wise Students t-test
    Statistical analysis description
    Values represent spatial differences obtained in the region indicated
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - Values equal to or lower than 0.05 are considered significant. P-values according to facial region: Neck: 0.99 Chin: 0.72 Mouth: 0.29 Nose:0.72 Eyes: 0.63 Forehead: 0.15 Cheek: 0.20

    Secondary: Hemoglobin at t0 according to intervention group

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    End point title
    		 Hemoglobin at t0 according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    At the start of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    41
    Units: gram(s)/millilitre
        arithmetic mean (confidence interval 95%)
    8.3 (7.7 to 8.8)
    8.3 (7.5 to 8.9)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.55 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [2] - Non significant correlation

    Secondary: Hematocrit t0 according to intervention group

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    End point title
    		 Hematocrit t0 according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    At the start of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: litre(s)/litre(s)
        arithmetic mean (confidence interval 95%)
    0.39 (0.37 to 0.42)
    0.39 (0.36 to 0.41)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. The Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Variability estimate
    Standard deviation

    Secondary: Platelet count t0 according to intervention group

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    End point title
    		 Platelet count t0 according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    At the start of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    41
    Units: Blood platelets/microlitre(s) of blood
        arithmetic mean (confidence interval 95%)
    216 (174 to 250)
    208 (170 to 258)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. The Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Placebo v Intervention
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.72
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Age of study subjects according to intervention group

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    End point title
    		 Age of study subjects according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    Date of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    41
    Units: Years of age
        arithmetic mean (confidence interval 95%)
    21 (19.0 to 28.8)
    22 (20.0 to 27.5)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. The Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Procedure length according to intervention group

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    End point title
    		 Procedure length according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: Minutes
        arithmetic mean (confidence interval 95%)
    240 (219 to 272)
    254 (218 to 270)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. The Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Weigth of study subjects according to intervention group

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    End point title
    		 Weigth of study subjects according to intervention group
    End point description
    End point type
    Secondary
    End point timeframe
    On the date of surgery
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    51
    45
    Units: Kg(s)
        arithmetic mean (confidence interval 95%)
    75 (65.5 to 82.8)
    73.5 (61.0 to 83.0)
    Statistical analysis title
    		 Mann-Whitney U test
    Statistical analysis description
    The Mann-Whitney U test was applied to compare differences between TXA and placebo. The Kolmogorov-Smirnov test was used for the initial evaluation of distribution of data.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.78
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of surgery and 48 hours after the first 3D scan
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 OS patients recieving the active drug consisting of 1 gram bolus intravenous administered tranexamic acid after the induction of general anesthesia

    Reporting group title
    Placebo
    Reporting group description
    		 OS patients recieving inactive placebo agent consisting of 1 gram bolus intravenous administered sterile saline

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 96 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 96 (0.00%)
    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: Only one event occured, which evidently was a consequence from the maxillofaxial surgical procedure. This has been cleared by the local GCP representative. Thus no adverse or serious adverse events are declared.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2014
    It was decided to include patients recieving oral contraceptives. This was previously a cause for exclusion. The reason for the inclusion of oral contraceptive users was that the effect of these drugs on the hemostatic response to the surgery was thought to be negligible and by excluding this group a large proportion of the female study population would not represented in the final material.
    03 Nov 2014
    3D facial scans was added as a secondary outcome variable. This was done in order to quantify the degree of postoperative facial swelling and identify the possible effect of the active and placebo drug.
    17 Feb 2015
    The timing of the facial 3D scans were changed such that the preoperative scan, which initially was thought of as the "baseline" scan was moved to 4 months postoperative. The reason for this was that the movement of the jaw bones during surgery was identified as majo source of error due the concomitant shift in the overlying soft tissues. By scanning postoperatively a unifofm maxillofacial basis was secured and any changes in the surface structure more likely to stem from postoperative swelling alone. The reason for the four month mark was based on the clinical observation, that the majority of the facial edema has subsided at this point in time.

    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/29232560
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