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临床试验/NCT00948792
NCT00948792已完成不适用

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

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Change in Post-transfusion Platelet Counts

研究概览

简要总结

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

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Infants with significant thrombocytopenia requiring a transfusion of platelets.

排除标准

  • •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.

研究组 & 干预措施

Long transfusion group

Active Comparator

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.

干预措施: Long platelet transfusion (Procedure)

Short transfusion group

Experimental

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.

干预措施: Short platelet transfusion (Procedure)

结局指标

主要结局

Change in Post-transfusion Platelet Counts

时间窗: 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

时间窗: 30 minutes - 6 hours after transfusion

Change in Post-transfusion Platelet Counts

时间窗: Baseline-30 minutes after transfusion

The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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