Determination of non-inferiority of volume-reduced platelet concentrates compared to plasma platelet concentrate in terms of recovery. To assess safety (bleeding and thrombotic complications, and adverse transfusion reactions) and transfusion…
ID
Source
Brief title
Condition
- Platelet disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess recovery, estimated by platelet transfusion increment at 1 hour and
24 hour.
Secondary outcome
1. To assess the safety (bleeding / thrombotic complications / adverse
transfusion reactions).
2. To assess the transfusion interval, estimated as interval to next
transfusion.
3. To assess the donor exposure.
Background summary
Platelet concentrates are used to prevent and treat bleeding complications. For
neonates, the standard platelet transfusion product is transfused at a dose of
10 (-20) ml per kg body weight. Volume overload caused by the need for
intravenous medication, blood products and parenteral nutrition, however, is a
serious clinical problem in neonates treated on the Neonatal Intensive Care
Unit (NICU). In these patients, the clinical transfusion requirements compete
with the risks associated with the volume overload. We hypothesize that by
using volume reduced platelet concentrates we can safely achieve comparable
platelet transfusion increments as with the standard platelet concentrate.
Study objective
Determination of non-inferiority of volume-reduced platelet concentrates
compared to plasma platelet concentrate in terms of recovery. To assess safety
(bleeding and thrombotic complications, and adverse transfusion reactions) and
transfusion requirement.
Study design
Randomized clinical trial.
Intervention
Randomization of patients between platelet transfusion support with standard
plasma aphaeresis platelet concentrate: 10 * 10 9 platelets/kg body weight in a
volume of 10 mL/kg body weight (Arm A), or volume-reduced aphaeresis platelet
concentrates: 20 * 10 9 platelets/kg body weight in a volume of 2 mL/kg body
weight (Arm B).
Study burden and risks
Burden: The monitoring of platelet count increments 1 hour and 24 hour after
platelet transfusion is part of regular patient care. Before and after
transfusion ultrasounds of the venous catheters to detect any new thrombosis
will be made.
Risk: The volume-reduced product is the standard platelet concentrate for
transfusion in neonates in the NICU of the LUMC, Leiden. A recent retrospective
study comparing the platelet transfusion practices between both centres did not
show any risk associated with the volume-reduced blood product.
Group relatedness: Circulatory overload is a common clinical problem on the
NICU.
Dr Molewaterplein 60
3015GJ Rotterdam
NL
Dr Molewaterplein 60
3015GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Neonates, <28 days postnatal age, admitted to the neonatal or pediatric intensive care (NICU/PICU) with thrombocytopenia that require a platelet transfusion according to the clinical guidelines.
- Written informed consent by parent(s) or caregiver(s).
Exclusion criteria
- Neonatal allo-immune thrombocytopenia (NIATP)
- Maternal ITP
- Therapeutic platelet transfusion during surgery
- Platelet transfusion during red blood cell exchange.
- Platelet transfusion during extracorporal membrane oxygenation (ECMO).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37198.078.11 |