NCT05255445Completed
Red Blood Cell - IMProving trAnsfusions for Chronically Transfused Recipients
Red Blood Cell - IMProving trAnsfusions for Chronically Transfused Recipients (RBC-IMPACT)
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
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 efficacy in chronically and episodically transfused patients. The objective of the study is to determine how specific genetic and non-genetic factors in donors and recipients may impact RBC survival after transfusion - in short, what factors on both the donor and recipient side may improve the efficacy of the transfusion.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 157 (actual)
- First submitted
- 10 Feb 2022
- Start date
- 16 Mar 2022
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Westat
- Diseases
- Sickle cell disease, Thalassaemia, Childhood cancers
- NCT number
- NCT05255445
What you commit to
- Study type: Observational
- Participants enrolled: 157
- From 16 Mar 2022 to the primary completion date, 31 Mar 2024
- 14 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Current active auto-immune hemolytic anemia based on positive direct antiglobulin test (DAT) with laboratory evidence of hemolysis and increased transfusion requirement
Other
- Institutionalization or imprisonment
- Foster care
- Weight \<11 kg
- Institutionalization or imprisonment
- Foster care
- \[In domestic study only\] Microangiopathic hemolytic anemia
- Weight \<18 kg
Who the study is looking for
- 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)
- 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).
Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HEMOMINAS - Minas Gerais Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| HEMOAM - Amazonas Coordinator of this site? Confirm its status | Manaus | Brazil | Unknown status |
| HEMOPE - Pernambuco Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| HEMORIO - Rio De Janeiro Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Childrens Institute and Adult Clinics at Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Froedtert Hospital Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Versiti Wisconsin, Inc. Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Children's Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Weill Cornell Medical Collection (WCMC)/New York Presbyterian Hospital (NYPH) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Irving Medical Center/New York Presbyterian Hospital (NYPH) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York Blood Center (NYBC) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UCSF Benioff Children s Hospital Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Vitalant Research Institute Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.