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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390896
• Other study ID #: 112797
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: July 24, 2014
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Fondaparinux Sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux		1 month	Yes
Primary	Presence of absence of venous thromboembolism after treatment of fondaparinux		1 month	Yes
Primary	Occurrence of adverse events of bleeding		1 month	Yes