- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219035
A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).
August 15, 2014 updated by: University College, London
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie Scully, PI
- Phone Number: 07834322302
- Email: m.scully@ucl.ac.uk
Study Contact Backup
- Name: Debra Ellis
- Email: debra.ellis@uclh.nhs.uk
Study Locations
-
-
-
London, United Kingdom
- UCLH
-
Contact:
- Marie SCULLY
- Email: m.scully@ucl.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all acute admissions presenting with ?
stroke
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
stroke-ischaemic
no interventions
|
stroke -haemorrhagic
no intervention
|
stroke: not confirmed
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Scully, UCLH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
August 15, 2014
First Submitted That Met QC Criteria
August 15, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
August 18, 2014
Last Update Submitted That Met QC Criteria
August 15, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/0088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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