Thrombopoietin Levels and Platelet Transfusion in Neonates

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00549484
First received: October 24, 2007
Last updated: January 16, 2008
Last verified: January 2008
  Purpose

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.


Condition
Thrombocytopenia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Reduction in TPO levels following platelet transfusion [ Time Frame: Within 36 hours of transfusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg. [ Time Frame: Within 36 hours after platelet transfusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples were collected pre and post platelet transfusion. Samples included platelet count, thrombopoietin, and platelet factor 4.


Enrollment: 20
Study Start Date: May 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
10 mL/kg platelet transfusion
2
15 mL / kg platelet transfusion

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Infants who require platelet transfusion

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with major congenital malformations
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00549484

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Alex Kline, MD Christiana Hospital
Principal Investigator: David A. Paul, MD Christiana Hospital
  More Information

No publications provided

Responsible Party: T. Alex Kline, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00549484     History of Changes
Other Study ID Numbers: CCC#23049
Study First Received: October 24, 2007
Last Updated: January 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Thrombocytopenia
Thrombopoietin
Platelet Transfusion
Platelet Factor 4

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on August 25, 2014