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Transfusing Neonates Based on Platelet Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759980
First Posted: September 25, 2008
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Alfred I. duPont Hospital for Children
Thomas Jefferson University
Abington Memorial Hospital
Information provided by:
Christiana Care Health Services
  Purpose

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.


Condition
Thrombocytopenia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Total number of transfusions [ Time Frame: During NICU hospitalization ]

Secondary Outcome Measures:
  • Bleeding outcomes [ Time Frame: While the infant is thrombocytopenic ]
  • Compliance with transfusion guidelines [ Time Frame: During NICU hospitalization ]

Estimated Enrollment: 50
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Platelet Number
Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to the total number of platelets
Platelet Mass
Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to a combination of platelet number and platelet size (mass)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants who are thrombocytopenic and hospitalized in the NICU
Criteria

Inclusion Criteria:

  • Thrombocytopenic infants

Exclusion Criteria:

  • Major congenital anomalies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759980


Locations
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19711
A.I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Thomas Jefferson University
Abington Memorial Hospital
Investigators
Principal Investigator: Jody L Zisk, DO Christiana Care Health Services
Principal Investigator: David A Paul, MD Christiana Care Health Systems
  More Information

Responsible Party: Jody L. Zisk, DO, Christiana Care Health Systems
ClinicalTrials.gov Identifier: NCT00759980     History of Changes
Other Study ID Numbers: 28156
First Submitted: September 24, 2008
First Posted: September 25, 2008
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Christiana Care Health Services:
Thrombocytopenia
Platelet transfusion

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases