Neutrophil Extracellular Traps and Sickle Cell Disease

NCT02004808 | Unknown

• 1 other identifier: Tasmc-12-RE-0247-CTIL
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (1)

• measurements of neutrophil function

  at first admition (day 1)

Secondary Outcomes (1)

• measurements of neutrophil function

  at sickle cell crisis while hospitalized

Other Outcomes (1)

• measurements of neutrophil function

  before and during treatment with hydroxyurea

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

10CC of peripheral venous blood will be collected from each patient at several time points: at diagnosis ,during pain crisis , at Hydroxyurea treatment.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ronit Elhasid, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Elhasid, MD

CONTACT

972524266464; ronite@tasmc.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 9, 2013

Record last verified: 2012-07