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Transfusing Neonates Based on Platelet Mass

Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00759980
Enrollment
50
Registered
2008-09-25
Start date
2008-10-31
Completion date
2011-03-31
Last updated
2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia, Platelet transfusion

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.

Interventions

None listed

Sponsors

Alfred I. duPont Hospital for Children
CollaboratorOTHER
Thomas Jefferson University
CollaboratorOTHER
Abington Memorial Hospital
CollaboratorOTHER
Christiana Care Health Services
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

Inclusion criteria

* Thrombocytopenic infants

Exclusion criteria

* Major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Total number of transfusionsDuring NICU hospitalization

Secondary

MeasureTime frame
Bleeding outcomesWhile the infant is thrombocytopenic
Compliance with transfusion guidelinesDuring NICU hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026