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Platelet Function During ECMO (Extra Corporeal Membrane Oxygenation)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748878
First Posted: September 9, 2008
Last Update Posted: October 16, 2013
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.
Information provided by:
University of Utah
  Purpose
Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane. Platelet transfusions carry risks such as infections with bacteria or yeast, and development or worsening of pulmonary hypertension. It is likely that if fewer platelet transfusions can be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and patient outcomes improve. In order to better understand platelet function during ECMO, the investigators plan to serially determine the circulating platelet mass, plasma platelet factor 4 concentration, megakaryocyte mass (estimated by plasma thrombopoietin concentration), and platelet function as quantified by PFA100. Any patient on ECMO will be eligible for this pilot study of 5 patients. By understanding changes in platelet function, we hope to design a future study that may modify the frequency or need for platelet transfusions during ECMO.

Condition
Platelet Function Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Function During ECMO

Further study details as provided by University of Utah:

Enrollment: 5
Study Start Date: June 2008
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment.1 In general, a platelet transfusion is ordered for a patient on ECMO if the platelet count falls below 100,000/uL in order to prevent generalized hemorrhaging.1,2 The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane,3 but other mechanisms are also likely to be involved.4 Platelet transfusions carry risks as well as benefits.5 Infections with bacteria or yeast are the most commonly reported complications of platelet transfusions,6,7 but with multiple platelet transfusions the development or worsening of pulmonary hypertension may be another common adverse effect.8,9 Pulmonary hypertension can be the result of administering biologically active pro-inflammatory proteins (known to be present in platelet transfusions) into the venous circulation. Of note, the first capillary bed encountered will be within the pulmonary circulation.

It is likely that if fewer platelet transfusions could safely be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and thereby patient outcomes might improve.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient on ECMO will be eligible for study.
Criteria

Inclusion Criteria:

  • Any patient on ECMO will be eligible for study.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00748878


Locations
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Donald .Null, M.D. University of Utah
  More Information

Responsible Party: Donald Null M.D., University of Utah / Primary Childrens Medical Center
ClinicalTrials.gov Identifier: NCT00748878     History of Changes
Other Study ID Numbers: 28645
First Submitted: September 8, 2008
First Posted: September 9, 2008
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by University of Utah:
To better understand platelet function during ECMO

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases