Study of the Effect of Differing Platelet Transfusion Times in Neonates

Not Applicable

Completed

• Conditions: Thrombocytopenia
• Interventions: Procedure: Long platelet transfusion; Procedure: Short platelet transfusion

• Registration Number: NCT00948792
• Lead Sponsor: University of Oklahoma

Brief Summary

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

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-02-21
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-13
• Last Update Submitted: 2011-06-13
• Results First Posted: 2011-07-12
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long transfusion group	Long platelet transfusion	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.
Short transfusion group	Short platelet transfusion	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.

Primary Outcome Measures

Name	Time	Method
Change in Post-transfusion Platelet Counts	Baseline - 6 hours after transfusion	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	30 minutes - 6 hours after transfusion

Trial Locations

Locations (1)

Children's Hospital of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States