Skip to main content
Clinical Trials/NCT00549484
NCT00549484
Completed
Not Applicable

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Christiana Care Health Services1 site in 1 country20 target enrollmentMay 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombocytopenia
Sponsor
Christiana Care Health Services
Enrollment
20
Locations
1
Primary Endpoint
Reduction in TPO levels following platelet transfusion
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2003
End Date
September 2004
Last Updated
18 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Infants with major congenital malformations

Outcomes

Primary Outcomes

Reduction in TPO levels following platelet transfusion

Time Frame: Within 36 hours of transfusion

Secondary Outcomes

  • Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.(Within 36 hours after platelet transfusion)

Study Sites (1)

Loading locations...

Similar Trials