Transfusing Neonates Based on Platelet Mass

Completed

• Conditions: Thrombocytopenia

• Registration Number: NCT00759980
• Lead Sponsor: Christiana Care Health Services

Brief Summary

Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed.

This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules.

The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number.

The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Study Start: 2008-10
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Thrombocytopenic infants

Exclusion Criteria

• Major congenital anomalies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of transfusions	During NICU hospitalization

Secondary Outcome Measures

Name	Time	Method
Compliance with transfusion guidelines	During NICU hospitalization
Bleeding outcomes	While the infant is thrombocytopenic

Trial Locations

Locations (4)

A.I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States