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Platelet transfusions in neonates

Platelet transfusions in neonates - PLANET study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36168
Enrollment
76
Registered
2011-09-16
Start date
2012-03-19
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thrombocytopenia

Interventions

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), o

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Neonates,

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
To assess recovery, estimated by platelet transfusion increment at 1 hour and 24 hour.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)