Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ADAMTS13 | stroke
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

Layout table for study information
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

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



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

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
Layout table for location contacts
Contact: Marie Scully, PI 07834322302 m.scully@ucl.ac.uk
Contact: Debra Ellis debra.ellis@uclh.nhs.uk

Locations
Layout table for location information
United Kingdom
UCLH Not yet recruiting
London, United Kingdom
Contact: Marie SCULLY       m.scully@ucl.ac.uk   
Sponsors and Collaborators
University College, London
Investigators
Layout table for investigator information
Principal Investigator: Marie Scully UCLH

Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02219035     History of Changes
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:
Layout table for MeSH terms
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