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Study to Assess Platelet Dysfunction With Verify Now Assay

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167218
First Posted: July 22, 2010
Last Update Posted: August 10, 2012
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.
Information provided by (Responsible Party):
Nina D'Abreo, MD, Winthrop University Hospital
  Purpose
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).

Condition
Platelet Aggregation Defects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: "In-vitro Characterization of Platelet Dysfunction in Common Hematological Disorders Using the Verify Now Assay"

Resource links provided by NLM:


Further study details as provided by Nina D'Abreo, MD, Winthrop University Hospital:

Primary Outcome Measures:
  • platelet aggregation defects [ Time Frame: one year ]
    to assess platelet aggregation defects


Enrollment: 79
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
verify now assay
subjects who have Myelodysplastic syndrome, immune thrombocytopenia, and myeloproliferative disorders with platelet disorders

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with platelet defects
Criteria

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

  Contacts and Locations
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): NCT01167218


Locations
United States, New York
Winthrop University Hospital Oncology/Hematology Division
Mineola, New York, United States, 11501
Sponsors and Collaborators
Nina D'Abreo, MD
Investigators
Principal Investigator: Nina D'abreo, MD Winthrop University Hospital
  More Information

Responsible Party: Nina D'Abreo, MD, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01167218     History of Changes
Other Study ID Numbers: 09318
First Submitted: July 19, 2010
First Posted: July 22, 2010
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Nina D'Abreo, MD, Winthrop University Hospital:
verify now assay for hematological disorders

Additional relevant MeSH terms:
Hematologic Diseases