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CompletedNCT00549484

Thrombopoietin Levels and Platelet Transfusion in Neonates

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Christiana Care Health Services · Academic / Other
Sex
All
Age
6 Months
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2003-05-01
Primary completion
2004-09-01
Completion
2004-09-01
First posted
2007-10-25
Last updated
2008-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00549484. Inclusion in this directory is not an endorsement.

Thrombopoietin Levels and Platelet Transfusion in Neonates (NCT00549484) · Clinical Trials Directory