Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT04134299 - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease N/A
Completed NCT04581356 - Voxelotor Sickle Cell Exercise Study Phase 4
Completed NCT02712346 - The Role of Endothelin-1 in Sickle Cell Disease Phase 1
Completed NCT01976416 - Novel Use Of Hydroxyurea in an African Region With Malaria Phase 3
Withdrawn NCT02162225 - Study of Beet Juice for Patients With Sickle Cell Anemia Phase 2
Completed NCT01137721 - State Of The Art Functional Imaging In Sickle Cell Disease
Terminated NCT01350232 - Treatment of Sickle Cell Anemia With Stem Cell Transplant N/A
Withdrawn NCT00937144 - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil Phase 4
Completed NCT00512564 - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00512226 - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00004143 - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes Phase 2
Completed NCT00004412 - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers Phase 2
Withdrawn NCT01925001 - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis Phase 2
Completed NCT01848691 - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis N/A
Completed NCT01783990 - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed NCT01000155 - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease Phase 2
Completed NCT00874172 - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy N/A
Completed NCT00236093 - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain Phase 2
Completed NCT00399074 - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia Phase 3
Completed NCT00004492 - Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia Phase 1/Phase 2