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OpenTrials
Completed

NCT Number: NCT00759980

Transfusing Neonates Based on Platelet Mass

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.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health System, Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thrombocytopenic infants

Exclusion criteria

  • Major congenital anomalies

Treatment and study plan

Primary outcomes

  1. Total number of transfusions

    Time frame: During NICU hospitalization

Secondary outcomes

  1. Bleeding outcomes

    Time frame: While the infant is thrombocytopenic

  2. Compliance with transfusion guidelines

    Time frame: During NICU hospitalization

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Abington Memorial Hospital
  • Alfred I. duPont Hospital for Children
  • Thomas Jefferson University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2008
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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