- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01167218
Study to Assess Platelet Dysfunction With Verify Now Assay
February 4, 2019 updated by: NYU Langone Health
"In-vitro Characterization of Platelet Dysfunction in Common Hematological Disorders Using the Verify Now Assay"
The purpose of this study is to conduct a Verify now assay to detect platelet aggregation defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura (ITP) and myeloproliferative disorders (MPD).
Study Overview
Status
Completed
Conditions
Detailed Description
Verify Now is a rapid, simple, point-of service assay to measure platelet aggregation.
The verify now assay is designed to assess platelet function based on the ability of activated platelets to bind fibrinogen.
It is hoped that this study will detect the subtle platelet functional abnormalities in patients with hematological disorders.
Study Type
Observational
Enrollment (Actual)
79
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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Mineola, New York, United States, 11501
- Winthrop University Hospital Oncology/Hematology Division
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with platelet defects
Description
Inclusion Criteria
- Patients with common blood disorders such as immune thrombocytopenia purpura(ITP) myelodysplastic syndrome MDS)and myeloproliferative disorders (MPV)
Exclusion Criteria
- Patients with normal platelet counts
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 |
|---|
|
verify now assay
subjects who have Myelodysplastic syndrome, immune thrombocytopenia, and myeloproliferative disorders with platelet disorders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
platelet aggregation defects
Time Frame: one year
|
to assess platelet aggregation defects
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nina D'abreo, MD, Winthrop University Hospital
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, 2009
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 21, 2010
First Posted (Estimate)
July 22, 2010
Study Record Updates
Last Update Posted (Actual)
February 6, 2019
Last Update Submitted That Met QC Criteria
February 4, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 09318
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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