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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02219035
• Other study ID #: 14/0088
• Status: Not yet recruiting
• Phase: Phase 1
• First received: August 15, 2014
• Last updated: August 15, 2014
• Start date: December 2014

Study information

• Verified date: August 2014
• Source: University College, London
• Contact: Marie Scully, PI
• Phone: 07834322302
• Email: m.scully[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: MREC
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Stroke

Locations

Country	Name	City	State
United Kingdom	UCLH	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity.		2 years	No