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CompletedNCT00549484Updated Jan 18, 2008

Thrombopoietin Levels and Platelet Transfusion in Neonates

An observational study in Thrombocytopenia, sponsored by Christiana Care Health Services. Completed at 1 site in United States. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-18.

Sponsored by Christiana Care Health Services · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
20
Ages
Up to 6 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thrombocytopenia

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Keywords

  • Thrombocytopenia
  • Thrombopoietin
  • Platelet Transfusion
  • Platelet Factor 4
03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Infants who require platelet transfusion

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Infants with major congenital malformations
05

Study design

Time perspective
Prospective
Enrollment
20 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    10 mL/kg platelet transfusion

  • 2

    15 mL / kg platelet transfusion

06

What researchers measure

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

07

Study locations

1 site
  • Christiana Hospital
    Newark, Delaware 19718, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00549484
Lead sponsor
Christiana Care Health Services
First posted
Oct 25, 2007
Start date
May 2003
Primary completion
Sep 2004
Completion
Sep 2004
Last update
Jan 18, 2008

Study contacts

Alex Kline, MD
principal investigator · Christiana Hospital
David A. Paul, MD
principal investigator · Christiana Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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