Last updated: 03/10/2020 14:20:08
A prospective cohort of adults’ patients with an acute symptomatic spontaneous SVT of lowers members, without DVP and followed during 3 months by vascular specialists after the diagnosis.PERSEUS
GSK study ID
116298
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
Trial overview
Official title: A prospective cohort of adults’ patients with an acute symptomatic spontaneous SVT of lowers members, without DVP and followed during 3 months by vascular specialists after the diagnosis.
Trial description: The main objective of this observational study is to describe the characteristics of adults patients treated for an acute symptomatic spontaneous SVT of lower members, without DVP, in terms of the therapeutic strategies.Study designAn observatory: physician will enter the first 20 patients with a diagnosis of SVT,A Cohort : all patients who present a SVT without a DVP and presenting with eligibility criteria as described in the protocol joined.Inclusion period : 6 monthsFollow-up period for patient included into the cohort : 3 months
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Describe the characteristics of patients treated for SVT, by therapeutic strategy
Timeframe: Inclusion
Secondary outcomes:
Evaluate the impact of the therapeutic strategy used in terms of health care consumption
Timeframe: throughout
Composite endpoint : number of VTE, death or major haemorrhages
Timeframe: throughout
Describe of the VTE : SVT extension, SVT recurrence, DVT, PE
Timeframe: Inclusion
Major haemorrhages events
Timeframe: throughout the study
describe the current clinic practice to treat SVT,
Timeframe: Inclusion
Interventions:
Other: Treatment with antithrombotic
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Thrombosis
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
May 2015 to September 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Observatory inclusion:
- 1/ Patient with acute symptomatic spontaneous SVT of lower members
- Observatory : no exlusion criteria
- Cohort
Inclusion and exclusion criteria
Inclusion criteria:
- Observatory inclusion: 1/ Patient with acute symptomatic spontaneous SVT of lower members Cohort Inclusion: 1/ an acute symptomatic spontaneous SVT of lower members, confirmed by an echo-Doppler, 2/ patient ≥ 18 years old, 3/ patient who signed an inform consent sheet
Exclusion criteria:
- Observatory : no exlusion criteria Cohort 1/ SVT secondary to sclerotherapy or a venous catheter, 2/ SVT associated to DVP or EP, 3/ patient treated by an anticoagulant therapy for any other reason than its SVT, 4/ patient not agreed to participate, 5/ patient that can not be followed during 3 months, 6/ participation in any study using an investigational drug.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Cancelled
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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