Study to Assess Platelet Dysfunction With Verify Now Assay

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina D'Abreo, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01167218
First received: July 19, 2010
Last updated: August 8, 2012
Last verified: August 2012
  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 Winthrop University Hospital:

Primary Outcome Measures:
  • platelet aggregation defects [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nina D'Abreo, MD, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01167218     History of Changes
Other Study ID Numbers: 09318
Study First Received: July 19, 2010
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
verify now assay for hematological disorders

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014