Last updated: 11/07/2018 05:00:46
Special Drug Use Investigation for ARIXTRA (fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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