The Implementation of the Automated Erythrocytapheresis in Egyptian Sickle Cell Disease Center

NCT03903289 | Unknown DMC

• 1 other identifier: FMASU M D 94/ 2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Improvements of health infrastructure, preventive care and clinical treatment have reduced the morbidity and mortality of sickle cell disease (SCD). However, SCD is still an increasing national health problem, with increase longevity the chronic effect of sustained hemolysis and episodic vaso-occlusive events and the recurrent episodes of ischemic reperfusion injury drive the development of progressive end organ complications and cardiovascular, pulmonary, neurological and renal systems are most commonly affected. Today there is hope for a cure using hematopoietic stem cell transplantation (HSCT). However, at present; the procedure is infrequently performed and very expensive. In this research we will assess the effect of implementation of the automated erythrocytapheresis in the outcome of sickle cell disease in single Egyptian center.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• The change of health related quality of life (HRQoL) is being assessed

  The medical Outcome Study (MOS) short form (SF-36) is a 36- item tool for measuring health status and outcome from the patients' perceptions

  assessed at enrollment and after one year of intervention

Study Arms (3)

Automated red cell exchange

EXPERIMENTAL

Automated red cell exchange

Procedure: Automated red cell exchange

Manual red cell exchange

ACTIVE COMPARATOR

Manual red cell exchange

Procedure: Manual red cell exchange

Simple red cell transfusion

SHAM COMPARATOR

Simple red cell transfusion

Procedure: Simple red cell transfusion

Interventions

Automated red cell exchange PROCEDURE

Erythrocytapheresis is an automated red cell exchange procedure that removes blood that contains HbS from the patient while simultaneously replacing that same volume with packed red cells free of HbS.

Also known as: Erythrocytapheresis

Automated red cell exchange

Manual red cell exchange PROCEDURE

Active Comparator: Manual red cell exchange

Manual red cell exchange

Simple red cell transfusion PROCEDURE

Active Comparator: Simple red cell transfusion

Simple red cell transfusion

Eligibility Criteria

• Age: 2 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient with sickle cell disease (HbS with other variant hemoglobin)
• Age from 2-30y old

You may not qualify if:

• Patients with other hemoglobinopathy Patients younger than two years

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Non-US, 11556, Egypt

RECRUITING

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

• Fatma Solima SE Ebeid, MD

  Faculty of Medicine, Ain Shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma SE Ebeid, MD

CONTACT

01095569596; dr.fatma_ebeid@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: April 4, 2019
• Study Start: August 16, 2017
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

EG (1)