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
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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 design
An 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 months
Follow-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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    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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