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Completed

NCT Number: NCT00549484

Thrombopoietin Levels and Platelet Transfusion in Neonates

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.

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Key information

Conditions

Thrombocytopenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Jacobs syndrome

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Hospital

Newark, Delaware, 19718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Infants with major congenital malformations

Treatment and study plan

Primary outcomes

  1. Reduction in TPO levels following platelet transfusion

    Time frame: Within 36 hours of transfusion

Secondary outcomes

  1. Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.

    Time frame: Within 36 hours after platelet transfusion

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 25, 2007
Registry last updated
Jan 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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