Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

NCT05612919 | Completed DMC

• 1 other identifier: BST-TSCU-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Erythrocyte Transfusion; Umbilical Cord Issue; Infant, Extremely Premature

Keywords

Anaemia of prematurity; Extremely preterm infants; Umbilical cord blood; Blood bank; Fetal hemoglobin

Outcome Measures

Primary Outcomes (5)

• Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion

  The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in extremely preterm infants (EPI)

  24 hours after the procedure

• Number of participants with abnormal vital signs after UCB-RBC transfusion

  The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  24 hours after the procedure

• Number of participants with altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion

  The number of participants with Altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  24 hours after the procedure

• Number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion

  The number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  24 hours after the procedure

• Number of participants with morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion

  The number of participants with Morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI

  24 hours after the procedure

Secondary Outcomes (8)

• Feasibility of UCB-RBC in EPI

  within 6 hours of the request

• Total volumen of RBC transfused in transfused patients

  An average of 3 month (when patients are 36 weeks of postmenstrual age)

• Number of RBC tranfusions in transfused patients

  An average of 3 month (when patients are 36 weeks of postmenstrual age)

• The number of days between two consecutive RBC transfusion in transfused patients

  An average of 3 month (when patients are 36 weeks of postmenstrual age)

• Total hemoglobin value (g/dl) in transfused patients

  Before transfusion, 24 hours, 1 week, 1 month after transfusion

Other Outcomes (3)

• Marrow regeneration

  1 month

• Ferritin value in transfused and non-transfused patients

  1 month

• Transferrin saturation index (%) in transfused and non-transfused patients

  1 month

Study Arms (3)

Patients exclusively transfused with UCB-RBC

EXPERIMENTAL

Interventional group infants arm will receive UCB-RBC bag when RBC transfusion is indicated as per standard practice, and when UCB-RBC is available within the first 6 hours of the request.

Other: Red blood cell from umbilical cord blood

Patients exclusively transfused with AB-RBC

ACTIVE COMPARATOR

Standard treatment group infants arm will receive AB-RBC when RBC transfusion is indicated as per standard practice, and compatible UCB-RBC bag is not available.

Other: Red blood cell from adult donor

Non transfused patients

NO INTERVENTION

Patients with no indications for RBC transfusion. Their clinical management will be the usual in our neonatal unit.

Interventions

Red blood cell from adult donor OTHER

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.

Patients exclusively transfused with AB-RBC

Red blood cell from umbilical cord blood OTHER

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.

Patients exclusively transfused with UCB-RBC

Eligibility Criteria

• Age: Up to 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent from parents or legal guardians
• Preterm infants born earlier than 28 weeks of gestational age.
• Admission to the neonatal intensive care unit of the participating hospital (Hospital Clínic of Barcelona)

You may not qualify if:

• Previous transfusion
• Isoimmunization
• Hydrops fetalis
• Major congenital malformations
• Congenital infections
• Hemoglobinopathies
• Extreme urgency of blood availability (hypovolemic shock, disseminated intravascular coagulopathy...)
• Be part of another clinical trial that may interfere with the results

Sponsors & Collaborators

• Banc de Sang i Teixits: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, Barcelona, 08028, Spain

Location

Related Publications (10)

• Widness JA. Pathophysiology of Anemia During the Neonatal Period, Including Anemia of Prematurity. Neoreviews. 2008 Nov 1;9(11):e520. doi: 10.1542/neo.9-11-e520.

  PMID: 20463861 BACKGROUND

• Jiramongkolchai K, Repka MX, Tian J, Aucott SW, Shepard J, Collins M, Kraus C, Clemens J, Feller M, Burd I, Roizenblatt M, Goldberg MF, Arevalo JF, Gehlbach P, Handa JT. Lower foetal haemoglobin levels at 31- and 34-weeks post menstrual age is associated with the development of retinopathy of prematurity : PacIFiHER Report No. 1 PacIFiHER Study Group (Preterm Infants and Fetal Haemoglobin in ROP). Eye (Lond). 2021 Feb;35(2):659-664. doi: 10.1038/s41433-020-0938-5. Epub 2020 May 14.

  PMID: 32409707 BACKGROUND

• Hellstrom W, Martinsson T, Hellstrom A, Morsing E, Ley D. Fetal haemoglobin and bronchopulmonary dysplasia in neonates: an observational study. Arch Dis Child Fetal Neonatal Ed. 2021 Jan;106(1):88-92. doi: 10.1136/archdischild-2020-319181. Epub 2020 Aug 26.

  PMID: 32847833 BACKGROUND

• Teofili L, Papacci P, Orlando N, Bianchi M, Molisso A, Purcaro V, Valentini CG, Giannantonio C, Serrao F, Chiusolo P, Nicolotti N, Pellegrino C, Carducci B, Vento G, De Stefano V. Allogeneic cord blood transfusions prevent fetal haemoglobin depletion in preterm neonates. Results of the CB-TrIP study. Br J Haematol. 2020 Oct;191(2):263-268. doi: 10.1111/bjh.16851. Epub 2020 Jun 8.

  PMID: 32510635 BACKGROUND

• Mohamed A, Shah PS. Transfusion associated necrotizing enterocolitis: a meta-analysis of observational data. Pediatrics. 2012 Mar;129(3):529-40. doi: 10.1542/peds.2011-2872. Epub 2012 Feb 20.

  PMID: 22351894 BACKGROUND

• Bianchi M, Giannantonio C, Spartano S, Fioretti M, Landini A, Molisso A, Tesfagabir GM, Tornesello A, Barbagallo O, Valentini CG, Vento G, Zini G, Romagnoli C, Papacci P, Teofili L. Allogeneic umbilical cord blood red cell concentrates: an innovative blood product for transfusion therapy of preterm infants. Neonatology. 2015;107(2):81-6. doi: 10.1159/000368296. Epub 2014 Nov 15.

  PMID: 25401961 BACKGROUND

• Gonzalez EG, Casanova MA, Samarkanova D, Aldecoa-Bilbao V, Teresa-Palacio M, Busquets EF, Figueras-Aloy J, Salvia-Roiges M, Querol S. Feasibility of umbilical cord blood as a source of red blood cell transfusion in preterm infants. Blood Transfus. 2021 Nov;19(6):510-517. doi: 10.2450/2020.0169-20. Epub 2020 Dec 18.

  PMID: 33370228 BACKGROUND

• Bianchi M, Orlando N, Barbagallo O, Sparnacci S, Valentini CG, Carducci B, Teofili L. Allogeneic cord blood red blood cells: assessing cord blood unit fractionation and validation. Blood Transfus. 2021 Sep;19(5):435-444. doi: 10.2450/2020.0138-20. Epub 2020 Nov 3.

  PMID: 33196415 BACKGROUND

• Kotowski M, Litwinska Z, Klos P, Pius-Sadowska E, Zagrodnik-Ulan E, Ustianowski P, Rudnicki J, Machalinski B. Autologous cord blood transfusion in preterm infants - could its humoral effect be the kez to control prematurity-related complications? A preliminary study. J Physiol Pharmacol. 2017 Dec;68(6):921-927.

  PMID: 29550804 BACKGROUND

• Strauss RG, Widness JA. Is there a role for autologous/placental red blood cell transfusions in the anemia of prematurity? Transfus Med Rev. 2010 Apr;24(2):125-9. doi: 10.1016/j.tmrv.2009.11.003.

  PMID: 20303035 BACKGROUND

MeSH Terms

Conditions

Anemia; beta-Thalassemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Miguel María Alsina Casanova, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot, open, non-randomized, single-center clinical study, whose main objective is to evaluate the safety, feasibility and efficacy of red blood cell from umbilical cord blood (UCB-RBC) transfusion in extremely preterm infants (EPI). When infants fit criteria for red blood cells transfusion the blood bank of reference will be contacted and availability of compatible UCB-RBC bags within those 6 hours will be checked. When it is possible (available compatible UCB-RBC bag within 6 hours), UCB-RBC will be transfused, otherwise patient will receive RBC from adult donor. Patients who initially received RBC from adult donor will remain in this group if repeated transfusions are needed. In patients who initially received UCB-RBC transfusion, availability of compatible UCB-RBC bags will have to be reviewed again. Only when it is not possible to transfuse UCB-RBC at this repeated occasion, the patient will receive RBC from adult blood donor.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: November 10, 2022
• Study Start: September 13, 2023
• Primary Completion: July 12, 2025
• Study Completion: July 12, 2025
• Last Updated: January 28, 2026

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)