search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Platelet transfusions in neonates.


- candidate number13100
- NTR NumberNTR3507
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jul-2012
- Secondary IDs2011-254 / NL37198.078.11; MEC / CCMO
- Public TitlePlatelet transfusions in neonates.
- Scientific TitlePlatelet transfusions in neonates.
- ACRONYMPLANET
- hypothesisBy using the volume reduced platelet concentrates we can safely achieve comparable platelet transfusion increments in sick neonates than with the standard platelet concentrate.
- Healt Condition(s) or Problem(s) studiedNeonatal thrombocytopenia, Platelet transfusion
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate15-nov-2013
- Target number of participants76
- InterventionsRandomization 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), or volume-reduced aphaeresis platelet concentrates:20 * 109 platelets/ kg body weight in a volume of 2 mL/ kg body weight.
- Primary outcome1 hour platelet transfusion increment.
- Secondary outcome1. 24 hour platelet transfusion increment;
2. Bleeding grade ≥ 2;
3. Thrombosis grade ≥2;
4. Adverse transfusion reactions;
5. Transfusion requirement and interval to the next platelet transfusion;
6. Donor exposure.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A.J. Willemze
- CONTACT for SCIENTIFIC QUERIESDr. A.J. Willemze
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsN/A
- Brief summaryPlatelet 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/kg body weight. Volume overload caused by th need for intravenous medication, blood products and parenteral nutrition, however, is a serious clinical problem in neonates treated on the Neonatal Intensive Care (NICU). In these patients, the clinical transfusion requirements compete with the risks associated with 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.
- Main changes (audit trail)
- RECORD5-jul-2012 - 28-aug-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl