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

NCT ID: NCT02219035

Last Updated: 2014-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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stroke-ischaemic

no interventions

No interventions assigned to this group

stroke -haemorrhagic

no intervention

No interventions assigned to this group

stroke: not confirmed

no intervention

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Scully

Role: PRINCIPAL_INVESTIGATOR

UCLH

Locations

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UCLH

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Marie Scully, PI

Role: CONTACT

07834322302

Debra Ellis

Role: CONTACT

Facility Contacts

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Marie SCULLY

Role: primary

Other Identifiers

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14/0088

Identifier Type: -

Identifier Source: org_study_id

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