Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants
NCT ID: NCT05612919
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2023-09-13
2025-07-12
Brief Summary
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Detailed Description
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RBC from umbilical cord blood (UCB-RBC) might be a better alternative as it does not change the hemoglobin profile and consequently might decrease the oxygen toxicity.
Several studies have evaluated the safety of UCB-RBC transfusions in preterm infants without finding a higher risk of complications compared with AB-RBC transfusions.
A pilot study has been designed to evaluate the safety of UCB-RBC for transfusion in EPI and to determine the feasibility and efficacy of UCB-RBC for transfusion in this group of patients.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Patients exclusively transfused with UCB-RBC
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.
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.
Patients exclusively transfused with AB-RBC
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.
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.
Non transfused patients
Patients with no indications for RBC transfusion. Their clinical management will be the usual in our neonatal unit.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
12 Weeks
ALL
No
Sponsors
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Banc de Sang i Teixits
OTHER
Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Principal Investigators
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Miguel María Alsina Casanova, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic of Barcelona
Barcelona, Barcelona, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BST-TSCU-01
Identifier Type: -
Identifier Source: org_study_id
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