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Study of the Effect of Differing Platelet Transfusion Times in Neonates

Primary Purpose

Thrombocytopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short platelet transfusion
Long platelet transfusion
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring platelets, transfusion, thrombocytopenia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants with significant thrombocytopenia requiring a transfusion of platelets.

Exclusion Criteria:

  • Infants requiring extracorporeal membranous oxygenation.
  • Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus).
  • Babies diagnosed with neonatal alloimmune thrombocytopenia.

Sites / Locations

  • Children's Hospital of Oklahoma

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Long transfusion group

Short transfusion group

Arm Description

This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.

This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.

Outcomes

Primary Outcome Measures

Change in Post-transfusion Platelet Counts
The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.
Change in Post-transfusion Platelet Counts
The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.
30 Minute-6 Hour Difference in Platelet Counts

Secondary Outcome Measures

Full Information

First Posted
July 27, 2009
Last Updated
June 13, 2011
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00948792
Brief Title
Study of the Effect of Differing Platelet Transfusion Times in Neonates
Official Title
The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.
Detailed Description
It is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion. We also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
platelets, transfusion, thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long transfusion group
Arm Type
Active Comparator
Arm Description
This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
Arm Title
Short transfusion group
Arm Type
Experimental
Arm Description
This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
Intervention Type
Procedure
Intervention Name(s)
Short platelet transfusion
Intervention Description
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes
Intervention Type
Procedure
Intervention Name(s)
Long platelet transfusion
Intervention Description
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.
Primary Outcome Measure Information:
Title
Change in Post-transfusion Platelet Counts
Description
The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.
Time Frame
Baseline-30 minutes after transfusion
Title
Change in Post-transfusion Platelet Counts
Description
The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.
Time Frame
Baseline - 6 hours after transfusion
Title
30 Minute-6 Hour Difference in Platelet Counts
Time Frame
30 minutes - 6 hours after transfusion

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants with significant thrombocytopenia requiring a transfusion of platelets. Exclusion Criteria: Infants requiring extracorporeal membranous oxygenation. Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus). Babies diagnosed with neonatal alloimmune thrombocytopenia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Dannaway, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12823341
Citation
British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of platelet transfusions. Br J Haematol. 2003 Jul;122(1):10-23. doi: 10.1046/j.1365-2141.2003.04468.x. No abstract available.
Results Reference
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PubMed Identifier
19117893
Citation
Josephson CD, Su LL, Christensen RD, Hillyer CD, Castillejo MI, Emory MR, Lin Y, Hume H, Easley K, Poterjoy B, Sola-Visner M. Platelet transfusion practices among neonatologists in the United States and Canada: results of a survey. Pediatrics. 2009 Jan;123(1):278-85. doi: 10.1542/peds.2007-2850.
Results Reference
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PubMed Identifier
14977890
Citation
Murray NA, Roberts IA. Neonatal transfusion practice. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F101-7. doi: 10.1136/adc.2002.019760.
Results Reference
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PubMed Identifier
12937037
Citation
Roberts I, Murray NA. Neonatal thrombocytopenia: causes and management. Arch Dis Child Fetal Neonatal Ed. 2003 Sep;88(5):F359-64. doi: 10.1136/fn.88.5.f359.
Results Reference
background
PubMed Identifier
18684573
Citation
Sola-Visner M, Saxonhouse MA, Brown RE. Neonatal thrombocytopenia: what we do and don't know. Early Hum Dev. 2008 Aug;84(8):499-506. doi: 10.1016/j.earlhumdev.2008.06.004. Epub 2008 Aug 5.
Results Reference
background
PubMed Identifier
18194380
Citation
Strauss RG. How I transfuse red blood cells and platelets to infants with the anemia and thrombocytopenia of prematurity. Transfusion. 2008 Feb;48(2):209-17. doi: 10.1111/j.1537-2995.2007.01592.x. Epub 2008 Jan 7.
Results Reference
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Study of the Effect of Differing Platelet Transfusion Times in Neonates

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