Study to Assess Platelet Dysfunction With Verify Now Assay
| Tracking Information | |||||
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| First Received Date ICMJE | July 19, 2010 | ||||
| Last Updated Date | August 8, 2012 | ||||
| Start Date ICMJE | December 2009 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
platelet aggregation defects [ Time Frame: one year ] [ Designated as safety issue: No ] to assess platelet aggregation defects |
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| Original Primary Outcome Measures ICMJE |
to assess coronary plaque level [ Time Frame: 5 years after radiation tx ] [ Designated as safety issue: No ] to compare plaque burden in coronary arteries in patietns who received radiotherapy for left versus right breast cancer |
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| Change History | Complete list of historical versions of study NCT01167218 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Assess Platelet Dysfunction With Verify Now Assay | ||||
| Official Title ICMJE | "In-vitro Characterization of Platelet Dysfunction in Common Hematological Disorders Using the Verify Now Assay" | ||||
| Brief Summary | 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | patients with platelet defects |
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| Condition ICMJE | Platelet Aggregation Defects | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | verify now assay
subjects who have Myelodysplastic syndrome, immune thrombocytopenia, and myeloproliferative disorders with platelet disorders |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 79 | ||||
| Completion Date | February 2012 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01167218 | ||||
| Other Study ID Numbers ICMJE | 09318 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nina D'Abreo, MD, Winthrop University Hospital | ||||
| Study Sponsor ICMJE | Nina D'Abreo, MD | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Winthrop University Hospital | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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