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Platelet transfusions in neonates.

Platelet transfusions in neonates.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28543
Enrollment
76
Registered
2012-07-05
Start date
2012-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

neonatal thrombocytenia platelet transfusion

Interventions

Randomization of patients between platelet trasnfusion support with standard plasma aphaeresis platelet concentrate: 10 * 109 platelets/ kg body weight in a volume of 10 mL/ kg body weight (Arm A), o

Sponsors

ErasmusMC - Sophia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates, <28 days corrected age, admitted to the neonatal or pediatric intensive care (NICU/PICU) with thrombocytopenia that require a platelet transfusion according to the clinical guidelines; 2. Written informed consent by parent(s) or caregiver(s).

Exclusion criteria

Exclusion criteria: 1. Neonatal allo-immune thrombocytopenia (NIATP); 2. Maternal ITP; 3. Therapeutic platelet transfusion during surgery; 4. Platelet transfusion during red blood cell exchange; 5. Platelet transfusion during extracorporal membrane oxygenation (ECMO).

Design outcomes

Primary

MeasureTime frame
1 hour platelet transfusion increment.

Secondary

MeasureTime frame
1. 24 hour platelet transfusion increment; 2. Bleeding grade &#8805; 2; 3. Thrombosis grade &#8805;2; 4. Adverse transfusion reactions; 5. Transfusion requirement and interval to the next platelet transfusion; 6. Donor exposure.

Contacts

Public ContactA.J. Willemze

Erasmus MC - Sophia Childrens Hospital Dept. of Oncology/Hematology Dr. Molewaterplein 60

A.Willemze@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)