Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

November 8, 2022 updated by: Hospital Clinic of Barcelona

Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Prematurity is an important maternal and child health problem due to its incidence and associated complications. Anaemia is a frequent problem in extremely preterm infants (EPI) whose treatment often requires red blood cell (RBC) transfusion. This product is currently obtained from adult blood (AB) donor. The incidence of some prematurity complications have been demonstrated to increase with AB-RBC tranfusions mainly because of the higher oxygen tissue release, such as retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and necrotizing enterocolitis (NEC). In addition, AB-RBC could contain small amounts of heavy metals that could be toxic for EPI.

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miguel María Alsina Casanova, MD
  • Phone Number: 7503 0034 93 227 56 00
  • Email: mmalsina@clinic.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.
No Intervention: Non transfused patients
Patients with no indications for RBC transfusion. Their clinical management will be the usual in our neonatal unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion
Time Frame: 24 hours after the procedure
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
Time Frame: 24 hours after the procedure
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
Time Frame: 24 hours after the procedure
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
Time Frame: 24 hours after the procedure
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
Time Frame: 24 hours after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of UCB-RBC in EPI
Time Frame: within 6 hours of the request
Feasibility will be considered proven if UCB-RBC is available in >50% of patients
within 6 hours of the request
Total volumen of RBC transfused in transfused patients
Time Frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
Total volumen of RBC transfused measured in milliliters will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)
An average of 3 month (when patients are 36 weeks of postmenstrual age)
Number of RBC tranfusions in transfused patients
Time Frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
The total number of RBC transfusions will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)
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
Time Frame: An average of 3 month (when patients are 36 weeks of postmenstrual age)
The number of days between two consecutive RBC transfusion in each transfused patient will be evaluated to assess the efficacy of UCB-RBC in EPI according to the treatment group (only UCB-RBC, only AB-RBC, both)
An average of 3 month (when patients are 36 weeks of postmenstrual age)
Total hemoglobin value (g/dl) in transfused patients
Time Frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Total hemoglobin (g/dl) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) An increment in total hemoglobin by 4 ± 2 g / dL 24 hours after the transfusion will be considered significative. Samples will be analysed by microhematocrit method ("Rapidpoint 5000 system, Siemens").
Before transfusion, 24 hours, 1 week, 1 month after transfusion
Hematocrit value (%) in transfused patients
Time Frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Hematocrit (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) An increment in hematocrit by 12 ± 5 points 24 hours after the transfusion will be considered significative. Samples will be analysed by microhematocrit method ("Rapidpoint 5000 system, Siemens").
Before transfusion, 24 hours, 1 week, 1 month after transfusion
Fetal haemoglobin value (%) in transfused patients
Time Frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Fetal haemoglobin (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC) A variation of fetal haemoglobin percentage between values before and after the transfusion will be considered significative. It will be analysed by capillary electrophoresis ("Capillary neonatal Hb" kit).
Before transfusion, 24 hours, 1 week, 1 month after transfusion
Regional cerebral and somatic oxygen saturation (%) value
Time Frame: Before transfusion, 24 hours, 1 week, 1 month after transfusion
Regional cerebral and somatic oxygen saturation (%) in transfused patients will be evaluated to assess the efficacy of UCB-RBC in EPI according to the type of transfusion (UCB-RBC vs AB-RBC). Measurements will be taken by near-infrared spectroscopy
Before transfusion, 24 hours, 1 week, 1 month after transfusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marrow regeneration
Time Frame: 1 month
Comparison of reticulocyte counts between transfused and non-transfused patients.
1 month
Ferritin value in transfused and non-transfused patients
Time Frame: 1 month
Ferritin value will be assessed to comparison iron metabolism in transfused and non-transfused patients
1 month
Transferrin saturation index (%) in transfused and non-transfused patients
Time Frame: 1 month
Transferrin saturation index (%) will be assessed to comparison iron metabolism in transfused and non-transfused patients
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Institut d'Investigacions Biomèdiques August Pi i Sunyer
Banc de Sang i Teixits

Investigators

  • Principal Investigator: Miguel María Alsina Casanova, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BST-TSCU-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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