Cardiovascular DiseaseNCT01390896
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
An observational study of Cardiovascular Disease, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Fondaparinux Sodium
- How many people
- 329 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
Who may be able to join
- Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
Who cannot join
- 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
About this study
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Fondaparinux Sodium
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux SodiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients prescribed fondaparinux | Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism Receives: Drug: Fondaparinux Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux
Measured: 1 month
Presence of absence of venous thromboembolism after treatment of fondaparinux
Measured: 1 month
Occurrence of adverse events of bleeding
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390896
- Sponsor's protocol ID
- 112797
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2011
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
- ClinicalTrials.gov ID
- NCT01390896
- Acronym / sponsor ID
- 112797
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed fondaparinux | – | Drug: Fondaparinux SodiumPatients undergoing general surgery of the lower limb at high risk for venous thromboembolism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
Key inclusion criteria (1 listed)
- Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fondaparinux Sodium | Drug | Patients prescribed fondaparinux |
Primary outcome
The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux
Time frame: 1 month
Presence of absence of venous thromboembolism after treatment of fondaparinux
Time frame: 1 month
Occurrence of adverse events of bleeding
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.