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Study of the Effect of Differing Platelet Transfusion Times in Neonates

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00948792
First received: July 27, 2009
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Thrombocytopenia
 Procedure: Short platelet transfusion
Procedure: Long platelet transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Change in Post-transfusion Platelet Counts [ Time Frame: Baseline-30 minutes after transfusion ] [ Designated as safety issue: No ]
    The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.

  • Change in Post-transfusion Platelet Counts [ Time Frame: Baseline - 6 hours after transfusion ] [ Designated as safety issue: No ]
    The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.

  • 30 Minute-6 Hour Difference in Platelet Counts [ Time Frame: 30 minutes - 6 hours after transfusion ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Long transfusion group
This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
 Procedure: Long platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.
Experimental: Short transfusion group
This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
 Procedure: Short platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes

Detailed Description:
  1. 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.
  2. 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948792

Locations
United States, Oklahoma
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Douglas Dannaway, M.D. University of Oklahoma
  More Information

Publications:

Responsible Party: Doug Dannaway / Assistant Professor of Pediatrics, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00948792     History of Changes
Other Study ID Numbers: 14626
Study First Received: July 27, 2009
Results First Received: February 21, 2011
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
platelets
transfusion
thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013