MedTrace Logo

Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

NCT05612919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-01-28

No results posted yet for this study

Summary

This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.

Conditions

  • Infant, Extremely Premature
  • Erythrocyte Transfusion
  • Umbilical Cord Issue

Interventions

OTHER

Red blood cell from umbilical cord blood

Patients will receive a volume of 15-20 ml/kg of red blood cell from umbilical cord blood (UCB-RBC). The transfusion will be prescribed and administered with all the routine safety measures carried out by the nurses to ensure compatibility between the administered RBC and the patient. The UCB-RBC bags will contain a minimum volume of 20 mL of RBC, with a haematocrit of about 60% and an acceptable residual leucocyte content of \<106/mm3. Product validation is currently under development.

OTHER

Red blood cell from adult donor

Patients will receive a volume of 15-20 ml/kg of red blood cell from adult donor according to standard guidelines. The transfusion will be prescribed and administered with all the routine safety measures carried out by the nurses to ensure compatibility between the administered RBC and the patient. Blood samples are irradiated according to standard practise.

Sponsors & Collaborators

  • Banc de Sang i Teixits

    collaborator OTHER

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Miguel María Alsina Casanova, MD · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2025-07-12
Completion
2025-07-12

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612919 on ClinicalTrials.gov