Thrombopoietin Levels and Platelet Transfusion in Neonates

Completed

• Conditions: Thrombocytopenia

• Registration Number: NCT00549484
• Lead Sponsor: Christiana Care Health Services

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.

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-25
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-16
• Last Update Posted: 2008-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Infants with major congenital malformations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in TPO levels following platelet transfusion	Within 36 hours of transfusion

Secondary Outcome Measures

Name	Time	Method
Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.	Within 36 hours after platelet transfusion

Trial Locations

Locations (1)

Christiana Hospital; 🇺🇸 Newark, Delaware, United States