Transfusing Neonates Based on Platelet Mass

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759980
• Other study ID #: 28156
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: March 22, 2011
• Start date: October 2008
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Thrombocytopenic infants

Exclusion Criteria:

• Major congenital anomalies

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Christiana Care Health System	Newark	Delaware
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	A.I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
Christiana Care Health Services	Abington Memorial Hospital, Alfred I. duPont Hospital for Children, Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of transfusions		During NICU hospitalization	Yes
Secondary	Bleeding outcomes		While the infant is thrombocytopenic	Yes
Secondary	Compliance with transfusion guidelines		During NICU hospitalization	Yes