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Thrombopoietin Levels and Platelet Transfusion in Neonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549484
First Posted: October 25, 2007
Last Update Posted: January 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Christiana Care Health Services
  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 ]

Secondary Outcome Measures:
  • Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg. [ Time Frame: Within 36 hours after platelet transfusion ]

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

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: T. Alex Kline, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00549484     History of Changes
Other Study ID Numbers: CCC#23049
First Submitted: October 24, 2007
First Posted: October 25, 2007
Last Update Posted: January 18, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases