Study of the Effect of Differing Platelet Transfusion Times in Neonates

University of Oklahoma (OU)

Status: Completed

Conditions: Thrombocytopenia

Treatments: Procedure: Short platelet transfusion; Procedure: Long platelet transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00948792

14626

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Long transfusion group

Active Comparator group

Description:

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.

Treatment:

Procedure: Long platelet transfusion

Short transfusion group

Experimental group

Description:

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.

Treatment:

Procedure: Short platelet transfusion