Last updated: 11/03/2018 09:50:24
Prevention of venous thromboembolic events with ARIXTRA® 2,5 mg for medical ill patients.ARCHIMED HOSP
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: ArchiMed Hospital : Prevention of venous thromboembolic events with ARIXTRA® 2,5 mg for medical ill patients.
Trial description: The main objective is to describe patients in hospital practice with ARIXTRA® 2,5 mg in thromboprophylaxy: patients' profile and use of treatment.This study is epidemiological, prospective, observational, national and multicentric in two parts :-Constitution of a registry that will collect data on prescriptions of ARIXTRA® 2.5 mg in thromboprophylaxy indication for medical ill patients during one month -Collection of specific data on the 15 first medical ill patients receiving ARIXTRA® 2.5 mg in thromboprophylaxy indicationThe target population is represented by patients in hospital with an initiation of ARIXTRA® 2,5 mg as thromboprophylaxy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The primary study endpoint will be the observed mean duration of ARIXTRA® 2.5 mg treatment
Timeframe: approximatively 23 month
Secondary outcomes:
To describe the population treated by ARIXTRA 2.5mg in real life
Timeframe: approximatively 23 month
Interventions:
Other: Fondaparinux
Enrollment:
650
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Thromboembolism
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
March 2009 to March 2012
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Patients aged at least 18 years
- Hospitalised in one of the centre care departments (excluding surgery),
- Patient receiving ARIXTRA® 2.5 mg within the scope of another treatment indication (prevention of venous thromboembolic events in patients undergoing major orthopaedic surgery of the lower limb or abdominal surgery; treatment of deep vein thrombosis (DVT) and acute pulmonary embolism (PE)).
- Patient with coronary syndrome
Inclusion and exclusion criteria
Inclusion criteria:
- Patients aged at least 18 years Hospitalised in one of the centre care departments (excluding surgery), In whom ARIXTRA® 2.5 mg treatment is initiated in the hospital for medical thromboprophylaxis (excluding surgery), for the prevention of venous thromboembolic events, in patients deemed at high-risk, confined to bed for an acute medical disorder).
Exclusion criteria:
- Patient receiving ARIXTRA® 2.5 mg within the scope of another treatment indication (prevention of venous thromboembolic events in patients undergoing major orthopaedic surgery of the lower limb or abdominal surgery; treatment of deep vein thrombosis (DVT) and acute pulmonary embolism (PE)). Patient with coronary syndrome Patient who has already received treatment by ARIXTRA® 2.5 mg (during the previous 15 days) Patient receiving ARIXTRA® 5, 7.5, or 10 mg Patient who had had a surgery during the last 2 months Patient participating in a clinical trial Patient refusing to take part in the study
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
2012-20-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website