Study of the Effect of Differing Platelet Transfusion Times in Neonates

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

Detailed Description
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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.

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

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Procedure: Short platelet transfusion
* Procedure: Long platelet transfusion


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long transfusion group<br>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<br>* 15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.<br>|
| Experimental: Short transfusion group<br>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<br>* 15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-transfusion Platelet Counts | The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion. | Baseline-30 minutes after transfusion | 
| Change in Post-transfusion Platelet Counts | The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion. | Baseline - 6 hours after transfusion | 
| 30 Minute-6 Hour Difference in Platelet Counts |  | 30 minutes - 6 hours after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelets, transfusion, thrombocytopenia