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
Study complete
Study complete
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:
Enrollment:
650
Primary completion date:
Not applicable
Observational study model:
Cohort
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)
This study does not involve prospective enrollment of participants.
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
Study complete
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
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