Transfusing Neonates Based on Platelet Mass
|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.|
|ClinicalTrials.gov Identifier: NCT00759980|
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : March 23, 2011
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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to the total number of platelets
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)
- Total number of transfusions [ Time Frame: During NICU hospitalization ]
- Bleeding outcomes [ Time Frame: While the infant is thrombocytopenic ]
- Compliance with transfusion guidelines [ Time Frame: During NICU hospitalization ]
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
|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|
|Principal Investigator:||Jody L Zisk, DO||Christiana Care Health Services|
|Principal Investigator:||David A Paul, MD||Christiana Care Health Systems|