Multisite Protocols

TIPI: Transfusion in Preterm Infants – A REDS-IV-P & Vermont Oxford Network (VON) Collaboration

Logo of REDS-IV-P & Vermont Oxford Network (VON) Collaboration

Robust clinical data from the outcomes-oriented Vermont Oxford Network (VON) will be combined with data from very low birth weight (VLBW) infants in the REDS-IV-P Vein-to-Vein (Donor, Component, and Recipient) Database, to provide a thorough evaluation of transfusion practices and neonatal outcomes using rigorously ascertained diagnoses with standardized and well-accepted definitions.  Temporality of relevant clinical events in relation to transfusion will be evaluated by local onsite chart review.

Hypothesis:  Modifiable variation in transfusion practice, transfused products, and donor characteristics will be associated with serious adverse outcomes in VLBW infants.

The study will focus on recipient outcomes including necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), moderate/severe bronchopulmonary dysplasia (BPD), late onset sepsis, intraventricular hemorrhage (IVH), and death.  The primary (composite) outcome will be survival without morbidity until hospital discharge, and the secondary outcome will be individual components of the primary outcome.

Predictor variables of interest include:

  • Recipient pre-transfusion hemoglobin or platelet count
  • Blood donor characteristics (e.g., ABO type)
  • Blood components and modifications (e.g. storage solution, irradiation)

RBC-IMPACT: Red Blood Cell – IMProving trAnsfusions for Chronically Transfused recipients

This multi-site study in the United States and Brazil assesses how donor, component and recipient factors contribute to red blood cell (RBC) survival in chronically and episodically transfused patients – specifically, patients with sickle cell disease (SCD), thalassemia, and pediatric patients with chemotherapy-induced aplasia. The goal is to learn more about how to select the best units to optimize RBC transfusions in these heavily transfused populations. The overarching hypothesis is that there are specific donor genetic and non-genetic factors, as well as component and recipient factors, that will influence the effectiveness of RBC transfusions, and that specific donor genotypes will lead to worse outcomes in some patients.  The study will assess markers of RBC survival in recipients on simple transfusion therapy using data obtained from a low cost single nucleotide polymorphism (SNP) array, laboratory measures of RBC quality, and clinical care data. RBC survival will primarily be defined and measured by change in hemoglobin per day between visits. The study will collect donor blood samples for the genetic SNP array testing, as well as pre- and post-transfusion samples from enrolled participants and residual blood from the transfused unit (transfusate), some of which will be biobanked for future analyses. Statistical analyses of the linked data, using a variety of univariable associations and multivariable linear mixed effects modeling, will examine the effects of donor, component, and recipient factors on RBC survival. Outcomes of these analyses will help define factors that may lengthen the interval between transfusions in these chronically transfused populations and ultimately reduce a patient’s transfusion burden and iron overload.