Thrombopoietin Levels and Platelet Transfusion in Neonates

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

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.

Study Overview

• Status: Completed
• Conditions: Thrombocytopenia

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants who require platelet transfusion

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Infants with major congenital malformations

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; 10 mL/kg platelet transfusion
2; 15 mL / kg platelet transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in TPO levels following platelet transfusion	Within 36 hours of transfusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.	Within 36 hours after platelet transfusion

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Principal Investigator: David A. Paul, MD, Christiana Hospital; Principal Investigator: Alex Kline, MD, Christiana Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 24, 2007
• First Posted (Estimate): October 25, 2007

Study Record Updates

• Last Update Posted (Estimate): January 18, 2008
• Last Update Submitted That Met QC Criteria: January 16, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Thrombocytopenia; Thrombopoietin; Platelet Transfusion; Platelet Factor 4
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: CCC#23049