Study of Blood Platelets in Sickle Cell Disease | NCT00226083

Studies
Study of Blood Platelets in Sickle Cell Disease

NCT00226083

Sponsor

Rockefeller University

Status

Withdrawn

Last Update Posted

Jun 9, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Sickle Cell Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI returned to India

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Sep 2007Estimated

Completion Date

Sep 2007Estimated

First Submitted Date

Sep 22, 2005

First Submission Date that Met QC Criteria

Sep 22, 2005

First Posted Date

Sep 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2015

Last Update Posted Date

Jun 9, 2015Estimated

Name	Class
Icahn School of Medicine at Mount Sinai	OTHER
Schneider Children's Hospital of North Shore	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease.

Detailed Description

Research volunteers are seen in the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. The research volunteer's previous medical records will be requested. Upto 5 additional blood samples may be obtained in a subgroup of patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults and children > 7 years of age with sickle cell disease (Hb SS) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy.

Exclusion Criteria:

Current hydroxyurea therapy or,
Hydroxyurea use within the past 3 months
Blood transfusion or exchange transfusion within the past 3 months
Current treatment with aspirin or clopidogrel

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adults and children with sickle cell disease (Hb SS)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arun Shet, MD	Rockefeller University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rockefeller University Hospital		New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided