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Thrombopoietin Levels and Platelet Transfusion in Neonates

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00549484
Enrollment
20
Registered
2007-10-25
Start date
2003-05-31
Completion date
2004-09-30
Last updated
2008-01-18

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

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia, Thrombopoietin, Platelet Transfusion, Platelet Factor 4

Brief summary

Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.

Detailed description

Thrombocytopenia, defined as a platelet count \< 150,000/mm3, is a very common hematologic problem in the neonatal period. Multiple etiologies are known to be associated with thrombocytopenia in neonates. Thrombopoietin (TPO) is known to be the central regulator of megakaryocyte and platelet production in adults and infants. However, the role of TPO in neonatal platelet regulation is not well understood. TPO levels have been shown to be higher in neonates with thrombocytopenia, with a decrease in TPO after resolution of the thrombocytopenia. The response of TPO levels in neonates after platelet transfusion has never been studied. In addition, the optimal volume of platelet transfusions has never been studied in neonates. This study will evaluate the response to 2 different volumes of platelet transfusion. We hypothesize that a decrease in plasma TPO levels will be seen following a platelet transfusion in a population of neonates with thrombocytopenia. We also hypothesize that a platelet transfusion of 15 mL/kg will result in a greater rise in platelet count than a transfusion pf 10 mL/kg of platelets.

Interventions

None listed

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes

Inclusion criteria

* Preterm infants with thrombocytopenia * Decision made by medical team to transfuse with platelets

Exclusion criteria

* Infants with major congenital malformations

Design outcomes

Primary

MeasureTime frame
Reduction in TPO levels following platelet transfusionWithin 36 hours of transfusion

Secondary

MeasureTime frame
Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.Within 36 hours after platelet transfusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026