Last updated: 11/07/2018 05:00:46

Special Drug Use Investigation for ARIXTRA (fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

GSK study ID
112721
See study documents
Clinicaltrials.gov ID
NCT01390883
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Special Drug Use Investigation for ARIXTRA (fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
Trial description: The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of adverse events in Japanese patients treated with fondaparinux

Timeframe: 4 months at maximum

Presence or absence of venous thromboembolism after treatment of fondaparinux

Timeframe: 4 months at maximum

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fondaparinux Sodium
    • Enrollment:
    475
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Hiroharu Abe, Takeshi Ebihara, Terufumi Hara, Pasccal Yoshida.Special Drug Use Investigation of Arixtra® Injection (fondaparinux sodium) in Subjects with High Risk for VTE Undergoing Abdominal Surgery in Urology, Obstetrics and Gynecology.J Clin Therapeut Med.31(6):629-643
    Medical condition
    Cardiovascular Disease
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    December 2008 to October 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments
    • Patients with a history of hypersensitivity to the ingredients of fondaparinux
    • Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments
    Exclusion criteria:
    • Patients with a history of hypersensitivity to the ingredients of fondaparinux
    • Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
    • Patients with acute bacterial endocarditis
    • Patients with severe renal impairment

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-11-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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