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

NCT02219035 | Unknown DMC

• 1 other identifier: 14/0088
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

presentation with

Outcome Measures

Primary Outcomes (1)

• Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity.

  2 years

Study Arms (3)

stroke-ischaemic

no interventions

stroke -haemorrhagic

no intervention

stroke: not confirmed

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all acute admissions presenting with ? stroke

You may qualify if:

• 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.

You may not qualify if:

• Patients \<18 years old
• Patients with systemic vasculitis or active malignancy will be excluded.
• Patients not wishing to participate

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCLH

London, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marie Scully

  UCLH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Scully, PI

CONTACT

07834322302; m.scully@ucl.ac.uk

Debra Ellis

CONTACT

debra.ellis@uclh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 18, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

GB (1)