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

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ClinicalTrials.gov Identifier: NCT03903289
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Fatma Soliman Elsayed Ebeid, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Procedure: Automated red cell exchange Procedure: Manual red cell exchange Procedure: Simple red cell transfusion Not Applicable

Detailed Description:

There is a wide scoop for treatment of SCD ranging from medical treatment with hydroxyurea, simple transfusion with chelation therapy, exchange transfusion either manual or automated and stem cell transplantation which need highly equipped institutes.

The goals of treatment of SCD are symptom control with early detection and management of disease complications. Although several pharmacological agents have been studied for the treatment of SCD, the only drug currently approved by the US Food and Drug Administration (FDA) for the treatment of SCD is hydroxyurea. Allogeneic bone marrow transplantation (BMT) can cure SCD, but it is difficult to decide which patients should be offered BMT. Many risks are associated with BMT, and the risk-to-benefit ratio must be assessed carefully. The lack of availability of a matched donor may limit the utility of BMT. Transfusions are not needed for the usual anemia or episodes of pain associated with SCD. Urgent replacement of blood is often required for sudden severe anemia and regular blood transfusions are used for primary and secondary stroke prevention in children with SCD. With continued transfusion, iron overload inevitably develops and can result in heart and liver failure, and multiple other complications necessitate the use of chelation therapy.

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. Transfusion usually consists of sickle-negative, leuco-reduced, and phenotypically matched blood for red cell antigens. Erythrocytapheresis thus has the advantage of controlling iron accumulation in patients with SCD who undergo long-term transfusion, as well as the ability to allow rapid reduction of HbS concentrations to less than 30% without significantly increasing total hemoglobin concentration post transfusion. This precision is achieved because, before the start of the transfusion, the computer in the pheresis machine calculates the expected amount of packed RBCs required to obtain a specific post-transfusion hemoglobin level, using various physiologic parameters (eg, height, weight, Hb level). Further, erythrocytapheresis requires less time than simple transfusion of similar blood volumes. Although erythrocytapheresis is more expensive than simple transfusion, the additional costs associated with simple transfusions (ie, those of chelation and organ damage due to iron overload) make erythrocytapheresis more cost-effective than simple transfusion programs. Central venous access devices can safely be used for long-term erythrocytapheresis in patients with SCD with a low rate of complications.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Implementation of the Automated Erythrocytapheresis in the Outcome of Egyptian Sickle Cell Disease Patients: Single Center Experience
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : August 16, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Automated red cell exchange
Automated red cell exchange
Procedure: Automated red cell exchange
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.
Other Name: Erythrocytapheresis

Active Comparator: Manual red cell exchange
Manual red cell exchange
Procedure: Manual red cell exchange
Active Comparator: Manual red cell exchange

Sham Comparator: Simple red cell transfusion
Simple red cell transfusion
Procedure: Simple red cell transfusion
Active Comparator: Simple red cell transfusion




Primary Outcome Measures :
  1. The change of health related quality of life (HRQoL) is being assessed [ Time Frame: assessed at enrollment and after one year of intervention ]
    The medical Outcome Study (MOS) short form (SF-36) is a 36- item tool for measuring health status and outcome from the patients' perceptions



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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with other hemoglobinopathy Patients younger than two years


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): NCT03903289


Contacts
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Contact: Fatma SE Ebeid, MD 01095569596 dr.fatma_ebeid@yahoo.com

Locations
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Egypt
Faculty of Medicine, Ain Shams University Recruiting
Cairo, Non-US, Egypt, 11556
Contact: Fatma SE Ebeid, MD    01095569596    dr.fatma_ebeid@yahoo.com   
Principal Investigator: Fatma SE Ebeid, MD         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Fatma Solima SE Ebeid, MD Faculty of Medicine, Ain Shams university

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Responsible Party: Fatma Soliman Elsayed Ebeid, Assistant Professor of Pediatric, Ain Shams University
ClinicalTrials.gov Identifier: NCT03903289     History of Changes
Other Study ID Numbers: FMASU M D 94/ 2018
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn