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Clinical Trials/NCT00759980
NCT00759980
Completed
Not Applicable

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

Christiana Care Health Services4 sites in 1 country50 target enrollmentOctober 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombocytopenia
Sponsor
Christiana Care Health Services
Enrollment
50
Locations
4
Primary Endpoint
Total number of transfusions
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
March 2011
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Thrombocytopenic infants

Exclusion Criteria

  • Major congenital anomalies

Outcomes

Primary Outcomes

Total number of transfusions

Time Frame: During NICU hospitalization

Secondary Outcomes

  • Compliance with transfusion guidelines(During NICU hospitalization)
  • Bleeding outcomes(While the infant is thrombocytopenic)

Study Sites (4)

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