Transfusing Neonates Based on Platelet Mass

NCT00759980 | Completed

• 1 other identifier: 28156
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia; Platelet transfusion

Outcome Measures

Primary Outcomes (1)

• Total number of transfusions

  During NICU hospitalization

Secondary Outcomes (2)

• Bleeding outcomes

  While the infant is thrombocytopenic

• Compliance with transfusion guidelines

  During NICU hospitalization

Study Arms (2)

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 Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants who are thrombocytopenic and hospitalized in the NICU

You may qualify if:

• Thrombocytopenic infants

You may not qualify if:

• Major congenital anomalies

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Alfred I. duPont Hospital for Children: collaborator
• Thomas Jefferson University: collaborator
• Abington Memorial Hospital: collaborator

Study Sites (4)

Christiana Care Health System

Newark, Delaware, 19711, United States

Location

A.I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Jody L Zisk, DO

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

• David A Paul, MD

  Christiana Care Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 23, 2011

Record last verified: 2011-03

Locations

US (4)