Status:
COMPLETED
Red Blood Cell - IMProving trAnsfusions for Chronically Transfused Recipients
Lead Sponsor:
Westat
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Sickle Cell Disease
Thalassemia
Eligibility:
All Genders
Brief Summary
Red Blood Cell - IMProving trAnsfusions for Chronically Transfused recipients (RBC-IMPACT) is an observational cohort study to assess donor, component, and recipient factors that contribute to RBC eff...
Detailed Description
Sickle cell disease (SCD) and thalassemia are genetic disorders inducing anemia of differing pathophysiology. A primary therapy for preventing certain SCD complications (e.g., stroke) and for thalasse...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Aim #1):
- Well-characterized transfusion-dependent form of SCD or thalassemia (including Hemoglobin E-thalassemia and sickle-beta thalassemia) on chronic simple transfusion therapy or partial manual exchange
- On a regular simple RBC transfusion schedule, including partial manual exchange (i.e., 1-3 units scheduled every 2-6 weeks and on a minimum 6-month chronic transfusion trial; for partial manual exchange, the phlebotomy must be completed before the transfusion is started without a back and forth between rounds of phlebotomy and transfusion)
- Seen at any participating domestic hub hospital (i.e., Columbia University Irving Medical Center/Morgan Stanley Children's Hospital of New York, Weill Cornell Medical Center/Komansky Children's Hospital, Boston Children's Hospital, Froedtert \& Medical College of Wisconsin/Children's Wisconsin, University of California San Francisco, Benioff Children's Hospital Oakland) or enrolled in the Brazil REDS-IV-P sickle cell disease cohort and seen at any participating Brazil hemocenter (i.e., Childrens Institute and Adult Clinics at Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP, HEMOAM - Amazonas, HEMOMINAS - Minas Gerais, HEMOPE -Pernambuco, and HEMORIO - Rio de Janeiro)
- Exclusion Criteria (Aim #1):
- Institutionalization or imprisonment
- Foster care
- Weight \<11 kg
- Inclusion criteria (Aim #2):
- Either included in Aim #1 (consented patient with SCD or thalassemia) or patient with pediatric oncologic diagnosis under care in a pediatric hematology/oncology service with anemia due to chemotherapy or primary/secondary hypo-proliferative bone marrow requiring a RBC transfusion (including HSCT)
- \[In domestic study only\] Age ≤21 years old (many pediatric services include care of patients up to age 21, therefore the protocol will not limit by age but instead on whether they are seen in a pediatric service)
- Planned transfusion of RBC from an aliquot or unit from a single donor
- Seen at any participating domestic hub hospital (i.e., Columbia University Irving Medical Center/Morgan Stanley Children's Hospital of New York, Weill Cornell Medical Center/Komansky Children's Hospital, Boston Children's Hospital, Froedtert \& Medical College of Wisconsin/Children's Wisconsin, University of California San Francisco, Benioff Children's Hospital Oakland) or at any REDS-IV-P participating Brazil hemocenter (i.e., Childrens Institute and Adult Clinics at Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP, HEMOAM - Amazonas, HEMOMINAS - Minas Gerais, HEMOPE -Pernambuco, and HEMORIO - Rio de Janeiro).
- Exclusion criteria (Aim #2):
- Institutionalization or imprisonment
- Foster care
- Current active auto-immune hemolytic anemia based on positive direct antiglobulin test (DAT) with laboratory evidence of hemolysis and increased transfusion requirement
- \[In domestic study only\] Microangiopathic hemolytic anemia
- Weight \<18 kg
Exclusion
Key Trial Info
Start Date :
March 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT05255445
Start Date
March 16 2022
End Date
March 31 2024
Last Update
May 17 2024
Active Locations (14)
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1
UCSF Benioff Children's Hospital
Oakland, California, United States, 94609
2
Vitalant Research Institute
San Francisco, California, United States, 94118
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Weill Cornell Medical Collection (WCMC)/New York Presbyterian Hospital (NYPH)
New York, New York, United States, 10021