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A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).

Sponsor
University College, London (Other)
Overall Status
Unknown status
CT.gov ID
NCT02219035
Collaborator
(none)
200
Enrollment
1
Location

Study Details

Study Description

Brief Summary

In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13 levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global haemostasis will be assessed using thrombin generation and the relation between increase thrombin generation and VWF explored. Thrombin generation will be performed pre and post filtration for the presence of procoagulant microparticles. These parameters will be investigated acutely, at presentation and in convalescence; in addition, the effect on these parameters of treatment such as thrombolysis may be informative. Correlation between measured parameters and adverse clinical outcome would be used to identify markers of severity and progression of ischaemic stroke and identification of potential novel approaches to therapy that might improve outcome.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).
    Study Start Date :
    Dec 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    stroke-ischaemic

    no interventions
    stroke -haemorrhagic

    no intervention
    stroke: not confirmed

    no intervention

    Outcome Measures

    Primary Outcome Measures

    1. Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged >18 years of age presenting within 9 hours of onset of symptoms will be recruited from the hyperacute stroke unit at UCLH.

    • Patients in whom stroke has been excluded or in whom intracerebral haemorrhage has been diagnosed are to be included as 'controls'. The definitive diagnosis will not be immediately obvious at presentation.

    • Written consent will be obtained from patients or their nearest relative, particularly in patients with aphasia/dysphasia.

    Exclusion Criteria:

    • Patients <18 years old

    • Patients with systemic vasculitis or active malignancy will be excluded.

    • Patients not wishing to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLH London United Kingdom

    Sponsors and Collaborators

    • University College, London

    Investigators

    • Principal Investigator: Marie Scully, UCLH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT02219035
    Other Study ID Numbers:
    • 14/0088
    First Posted:
    Aug 18, 2014
    Last Update Posted:
    Aug 18, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by University College, London
    presentation with
    Additional relevant MeSH terms:
    Stroke
    Brain Injuries

    Study Results

    No Results Posted as of Aug 18, 2014