Last updated: 11/07/2018 05:14:14

Special Drug Use Investigation for ARIXTRA (fondaparinux) Abdominal General Surgery

GSK study ID
112797
See study documents
Clinicaltrials.gov ID
NCT01390896
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 General Surgery
Trial description: The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing 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 subjects undergoing general surgery of the lower limb treated with fondaparinux

Timeframe: 1 month

Presence of absence of venous thromboembolism after treatment of fondaparinux

Timeframe: 1 month

Occurrence of adverse events of bleeding

Timeframe: 1 month

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fondaparinux Sodium
    • Enrollment:
    329
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Hiroharu Abe, Takeshi Ebihara, Terufumi Hara, Pascal Yoshida.Special Drug Use Investigation of Arixtra® Injection (Fondaparinux Sodium) in Patients Undergoing General Abdominal Surgery.J Clin Therapeut Med.2014;30(11):943-955
    Medical condition
    Cardiovascular Disease
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to January 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
    • 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 general surgery of the lower limb at high risk for venous thromboembolism
    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
    2013-31-01

    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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