Ignite Creation Date:
2025-12-17 @ 9:10 PM
Ignite Modification Date:
2025-12-23 @ 10:14 PM
Study NCT ID:
NCT00759980
Status:
None
Last Update Posted:
2011-03-23 00:00:00
First Post:
2008-09-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transfusing Neonates Based on Platelet Mass
Sponsor:
None
Organization:
Study Overview
Official Title:
Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study
Status:
None
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: