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Completed

NCT Number: NCT00948792

Study of the Effect of Differing Platelet Transfusion Times in Neonates

To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.

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Key information

Conditions

Thrombocytopenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

About this study

  • It is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion.
  • We also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants with significant thrombocytopenia requiring a transfusion of platelets.

Exclusion criteria

  • Infants requiring extracorporeal membranous oxygenation.
  • Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus).
  • Babies diagnosed with neonatal alloimmune thrombocytopenia.

Treatment and study plan

Short platelet transfusion

Procedure

15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes

Long platelet transfusion

Procedure

15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.

Primary outcomes

  1. Change in Post-transfusion Platelet Counts

    Time frame: Baseline-30 minutes after transfusion

    The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.

  2. Change in Post-transfusion Platelet Counts

    Time frame: Baseline - 6 hours after transfusion

    The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.

  3. 30 Minute-6 Hour Difference in Platelet Counts

    Time frame: 30 minutes - 6 hours after transfusion

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2009
Registry last updated
Jul 12, 2011

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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