Neutrophil Extracellular Traps and Sickle Cell Disease | NCT02004808

Studies
Neutrophil Extracellular Traps and Sickle Cell Disease

NCT02004808

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 9, 2013Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Sickle Cell Anemia

Interventions

Not provided

Countries

Not provided

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Oct 15, 2013

First Submission Date that Met QC Criteria

Dec 3, 2013

First Posted Date

Dec 9, 2013Estimated

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

Dec 3, 2013

Last Update Posted Date

Dec 9, 2013Estimated

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

NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea treatment.The study hypothesis is that NETs formation by neutrophils has a role in the induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte count in children with sickle cell anemia is a bad prognostic sign due to NETs formation supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil count and inhibiting NETs formation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measurements of neutrophil function		at first admition (day 1)

Secondary Outcomes

Measure	Description	Time Frame
measurements of neutrophil function		at sickle cell crisis while hospitalized

Other Outcomes

Measure	Description	Time Frame
measurements of neutrophil function		before and during treatment with hydroxyurea

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children who suffer from sickle cell disease and/or children with sickle cell disease treated with hydroxyurea

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Infants and children who suffer from sickle cell disease and/or Infants and children with sickle cell disease treated with hydroxyurea at the pediatric hemato-oncology department

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ronit Elhasid, MD	Contact	972524266464		ronite@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Ronit Elhasid, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Not provided

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

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Browse Branches

Not provided