Study of the Effect of Differing Platelet Transfusion Times in Neonates

June 13, 2011 updated by: University of Oklahoma

The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns

To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Children's Hospital of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Long transfusion group
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.
Procedure: Long platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.
Experimental: Short transfusion group
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.
Procedure: Short platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Post-transfusion Platelet Counts
Time Frame: Baseline-30 minutes after transfusion
The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.
Baseline-30 minutes after transfusion
Change in Post-transfusion Platelet Counts
Time Frame: Baseline - 6 hours after transfusion
The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.
Baseline - 6 hours after transfusion
30 Minute-6 Hour Difference in Platelet Counts
Time Frame: 30 minutes - 6 hours after transfusion
30 minutes - 6 hours after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Douglas Dannaway, M.D., University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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