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Study of the Effect of Differing Platelet Transfusion Times in Neonates

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ClinicalTrials.gov Identifier: NCT00948792
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : July 12, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
University of Oklahoma

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

Condition or disease Intervention/treatment Phase
Thrombocytopenia Procedure: Short platelet transfusion Procedure: Long platelet transfusion Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns
Study Start Date : May 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

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): 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

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
First Posted: July 29, 2009    Key Record Dates
Results First Posted: July 12, 2011
Last Update Posted: July 12, 2011
Last Verified: June 2011

Keywords provided by University of Oklahoma:
platelets
transfusion
thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases