Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
HEMOMINAS - Minas Gerais
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
HEMOAM - Amazonas
Coordinator of this site? Confirm its status
ManausBrazilUnknown status
HEMOPE - Pernambuco
Coordinator of this site? Confirm its status
RecifeBrazilUnknown status
HEMORIO - Rio De Janeiro
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown 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 PauloBrazilUnknown status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Froedtert Hospital
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Versiti Wisconsin, Inc.
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Children's Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Weill Cornell Medical Collection (WCMC)/New York Presbyterian Hospital (NYPH)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Columbia University Irving Medical Center/New York Presbyterian Hospital (NYPH)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
New York Blood Center (NYBC)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
UCSF Benioff Children s Hospital
Coordinator of this site? Confirm its status
OaklandUnited StatesUnknown status
Vitalant Research Institute
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.