Thrombopoietin Levels and Platelet Transfusion in Neonates

Thrombocytopenia Clinical Trial

Official title:

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549484
• Other study ID #: CCC#23049
• Status: Completed
• Phase: N/A
• First received: October 24, 2007
• Last updated: January 16, 2008
• Start date: May 2003
• Est. completion date: September 2004

Study information

• Verified date: January 2008
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Preterm infants with thrombocytopenia

• Decision made by medical team to transfuse with platelets

Exclusion Criteria:

• Infants with major congenital malformations

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in TPO levels following platelet transfusion		Within 36 hours of transfusion	No
Secondary	Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.		Within 36 hours after platelet transfusion	No