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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02004808
Other study ID # Tasmc-12-RE-0247-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 15, 2013
Last updated December 3, 2013
Start date February 2014
Est. completion date December 2019

Study information

Verified date July 2012
Source Tel-Aviv Sourasky Medical Center
Contact Ronit Elhasid, MD
Phone 972524266464
Email ronite@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type Measure Description Time frame Safety issue
Other measurements of neutrophil function before and during treatment with hydroxyurea No
Primary measurements of neutrophil function at first admition (day 1) No
Secondary measurements of neutrophil function at sickle cell crisis while hospitalized No
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