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Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01390883
First received: July 7, 2011
Last updated: March 26, 2015
Last verified: March 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Cardiovascular Disease | Drug: Fondaparinux Sodium |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- The number of adverse events in Japanese patients treated with fondaparinux [ Time Frame: 4 months at maximum ]
- Presence or absence of venous thromboembolism after treatment of fondaparinux [ Time Frame: 4 months at maximum ]
| Enrollment: | 475 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients prescribed fondaparinux
Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period
|
Drug: Fondaparinux Sodium |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Japanese patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390883
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390883
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01390883 History of Changes |
| Other Study ID Numbers: |
112721 |
| Study First Received: | July 7, 2011 |
| Last Updated: | March 26, 2015 |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Fondaparinux PENTA Anticoagulants |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 16, 2017