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    Clinical Trial Results:
    Thromboprophylaxis in Oesophageal Cancer Patients – A Randomized, Controlled Trial

    Summary
    EudraCT number
    		 2021-001335-24
    Trial protocol
    		 DK  
    Global end of trial date
    01 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2025
    First version publication date
    31 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    141190
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Department of Clinical Biochemistry, Aarhus University Hospital, 0045 78455252, biokemi@auh.rm.dk
    Scientific contact
    Department of Clinical Biochemistry, Aarhus University Hospital, 0045 78455252, biokemi@auh.rm.dk
    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
    01 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.
    Protection of trial subjects
    Monitoring of side effects to study drug
    Background therapy
    		 All patients underwent intended curative surgery for oesophageal cancer.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 94
    Worldwide total number of subjects
    94
    EEA total number of subjects
    94
    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)
    35
    From 65 to 84 years
    59
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included between September 2021 and April 2024. Adult patients with esophageal adenocarcinomas or squamous cell carcinomas referred for intended curative esophagectomy at Aarhus University Hospital, Denmark, were included.

    Pre-assignment
    Screening details
    		 152 patients screened and of this 58 were not eligible due to: Cancelled surgery (n=6), logistics (n=12), ongoing anticoagulant treatment (n=28), declined to participate (n=9), not oesophageal cancer (n=2), inherited bleeding disorder (n=1)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard treatment
    Arm description
    		 The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Intervention arm
    Arm description
    		 The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fragmin®
    Investigational medicinal product code
    00069-0196-01
    Other name
    Dalteparin
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Solution for injection
    Dosage and administration details
    5,000 IU solution for injection in prefilled syringes

    Number of subjects in period 1
    		Standard treatment Intervention arm
    Started
    48
    46
    Completed
    39
    40
    Not completed
    9
    6
         Physician decision
    4
    3
         Protocol deviation
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard treatment
    Reporting group description
    		 The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care.

    Reporting group title
    Intervention arm
    Reporting group description
    		 The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days.

    Reporting group values
    		 Standard treatment Intervention arm Total
    Number of subjects
    		 48 46 94
    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
        median (inter-quartile range (Q1-Q3))
    		 66 (56 to 77) 68 (53 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 13 12 25
        Male
    		 35 34 69

    End points

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    End points reporting groups
    Reporting group title
    Standard treatment
    Reporting group description
    		 The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care.

    Reporting group title
    Intervention arm
    Reporting group description
    		 The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days.

    Primary: Levels of prothrombin fragment 1+2

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    End point title
    		 Levels of prothrombin fragment 1+2
    End point description
    End point type
    Primary
    End point timeframe
    Measured one month after surgery
    End point values
    		 Standard treatment Intervention arm
    Number of subjects analysed
    39
    40
    Units: pmol/L
        median (inter-quartile range (Q1-Q3))
    246 (182 to 262)
    232 (173 to 356)
    Statistical analysis title
    		 Primary endpoint analysis
    Statistical analysis description
    Difference in prothrombin fragment 1 + 2 levels in the 2 groups 1 month after surgery as an intention-to-treat analysis
    Comparison groups
    Standard treatment v Intervention arm
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion to one month after surgery.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2025-03-31
    Reporting groups
    Reporting group title
    Standard treatment
    Reporting group description
    		 The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care.

    Reporting group title
    Intervention arm
    Reporting group description
    		 The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days.

    Serious adverse events
    		 Standard treatment Intervention arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 39 (23.08%)
    7 / 40 (17.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Anastomosis leakage or fistula
         subjects affected / exposed
    4 / 39 (10.26%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Displaced intestine
    Additional description: Requiring reoperation
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
    Additional description: Following discharge requiring readmission
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardiac arrest with non-fatal outcome
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting and nausea
    Additional description: Vomiting, nausea and problems eating following discharge, of a degree requiring readmission
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    Additional description: Postoperative pneumonia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard treatment Intervention arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 40 (5.00%)
    Surgical and medical procedures
    Broken nasogastric tube
    Additional description: Requiring gastrocopy
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Reoperation
    Additional description: Due to displaced intestine
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Vasopressor requirement
    Additional description: Requiring readmission to ICU
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Generalized seizure
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1

    More information

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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.
    Risk of type II error due to low accrual

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39242497
    http://www.ncbi.nlm.nih.gov/pubmed/39842514
    http://www.ncbi.nlm.nih.gov/pubmed/40095681
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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