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Neutrophil Extracellular Traps and Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02004808
Recruitment Status : Not yet recruiting
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease
Sickle Cell Anemia

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia




Primary Outcome Measures :
  1. measurements of neutrophil function [ Time Frame: at first admition (day 1) ]

Secondary Outcome Measures :
  1. measurements of neutrophil function [ Time Frame: at sickle cell crisis while hospitalized ]

Other Outcome Measures:
  1. measurements of neutrophil function [ Time Frame: before and during treatment with hydroxyurea ]

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.


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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004808


Contacts
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Contact: Ronit Elhasid, MD 972524266464 ronite@tasmc.health.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Ronit Elhasid, MD Tel-Aviv Sourasky Medical Center

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02004808     History of Changes
Other Study ID Numbers: Tasmc-12-RE-0247-CTIL
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: July 2012

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn