Primary objective: To assess the feasibility of donor screening, collection, production and storage of sufficient CB-RBC products to potentially meet the transfusion need in extremely preterm neonates.
ID
Source
Brief title
Condition
- Red blood cell disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the number of CB-RBC products produced from CB
donations that meet the quality requirements and release specifications
according to the Dutch Guideline for Blood Products. In order to correlate the
number of collected CB-RBCs to the neonatal transfusion need, the number of RBC
transfusions required for neonates admitted to the EMC and LUMC Neonatal
Intensive Care Unit (NICU) will be recorded as well.
Secondary outcome
Not applicable
Background summary
Anemia occurs in almost all extremely preterm neonates born before 28 weeks of
gestation age (GA) and in neonates with extremely low birth weight <1000 gram.
These neonates receive on average of 2-4 red blood cell concentrate (RBC)
transfusions (1). Currently, RBCs are derived from blood, donated by adults.
This contains adult hemoglobin (HbA), whereas neonates have a predominance of
fetal hemoglobin (HbF). As a result, transfusion of adult-RBCs leads to a
marked decrease in HbF-levels in preterm neonates (2). As HbA has a different
oxygen-dissociation curve this negatively impacts the premature vascular
environment and still-developing organs by an increase in oxygen release
leading to inflammation and oxidative stress. In recent studies both RBC
transfusions as well as a steep decline in HbF levels are associated with
increased morbidity due to a higher incidence of prematurity-associated
diseases affecting eyes, lungs and gut (1, 4, 5). In order to prevent the
transfusion-provoked HbF decline, adult-RBCs should be replaced by transfusions
that are processed from a fetal or neonatal donor source, such as placenta or
cord blood (CB) from healthy, term neonates. A reservoir of blood that is
usually discarded. This new blood product must meet the European blood bank
standards as well as Dutch law and regulations. Therefore the Erasmus Medical
Center (EMC) and Leiden University Medical Center (LUMC) have cooperated with
Sanquin Blood Supply Foundation (Sanquin) since 2022 to develop a CB-derived
red blood cell concentrate transfusion product (CB-RBC) containing HbF, which
meets the standards to be transfused. In order to produce enough CB-RBC
product, the entire supply chain must function, including donor screening,
collection, production and storage.
Study objective
Primary objective: To assess the feasibility of donor screening, collection,
production and storage of sufficient CB-RBC products to potentially meet the
transfusion need in extremely preterm neonates.
Study design
Prospective multicenter cohort study in the EMC, LUMC and Maasstad Hospital.
Intervention:
1. Collection of residual CB of healthy, term neonates after the delivery of
the neonate and after delayed cord clamping is performed.
2. Collection of 10 mL blood in EDTA from the mother during hospital admission
for labour by venipuncture to perform donor screening according to guidelines.
Study burden and risks
Minimal burden, a single blood draw of 10 ml, collected in EDTA, from mother is
taken during admission by venipuncture (prior to delivery). Collection burden
of CB does not exist as CB is residual material.
The general common risks of venipuncture are apprehension, pain, discomfort,
extravasation of blood into the tissue causing a bruising or haematoma, and
presyncope, including pallor, light headedness, dizziness, nausea, diaphoresis.
Other less common and rare side effects are fainting, nerve irritation,
infection, arterial puncture, allergy (skin), neuropathic pain, phlebitis, and
deep vein thrombosis. Added discomfort associated with participation is
unlikely as there are no further interventions in routine care. There is no
direct benefit to the study participant. Real benefits are altruistic in
nature: participants joining in this study will assist in gathering important
information for safety and performance of CB for the collection, processing and
storage of CB-RBC products.
Dr. Molewaterplein 40 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40 40
Rotterdam 3015GD
NL
Listed location countries
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: pregnant women admitted to the department of
obstetrics in participating hospitals with a healthy term neonate, defined as a
GA >=37 weeks can be screened for donation in one of the participating
hospitals: EMC, LUMC and Maasstad Hospital. Donation criteria are based on the
regular blood donor selection criteria for whole blood donation (Dutch
Guideline for Donor Criteria: Richtlijn Donorkeuring, Sanquin ). Additional
criteria have been made by a working party of our consortium, taking the
particular situation into account involving both the pregnant woman as donor
and the preterm recipient. Additional standards are formulated for screening
for blood-borne infectious diseases and bacterial contamination as well as
medication use that can cross the placentas barrier. Informed consent and donor
screening is performed in the weeks leading up to birth by midwives,
gynaecologists, research nurses and researchers at the obstetrics department.
Transfusion requirements will be monitored of all extremely preterm neonates
admitted to EMC and LUMC NICU of which the parents have given consent for use
of clinical data for research purposes.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Unable to understand or refusing to sign an informed consent;
• Do not pass donation criteria.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL88831.078.25 |