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Trial record 1 of 1 for:    ADAMTS13 | stroke
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A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).

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ClinicalTrials.gov Identifier: NCT02219035
Recruitment Status : Unknown
Verified August 2014 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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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
Stroke

Study Design
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Study Type : Observational
Estimated 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 : December 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
stroke-ischaemic
no interventions
stroke -haemorrhagic
no intervention
stroke: not confirmed
no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all acute admissions presenting with ? stroke
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219035


Contacts
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Contact: Marie Scully, PI 07834322302 m.scully@ucl.ac.uk
Contact: Debra Ellis debra.ellis@uclh.nhs.uk

Locations
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United Kingdom
UCLH
London, United Kingdom
Contact: Marie SCULLY       m.scully@ucl.ac.uk   
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Marie Scully UCLH
More Information
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02219035    
Other Study ID Numbers: 14/0088
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by University College, London:
presentation with
Additional relevant MeSH terms:
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Stroke
Brain Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries