NCT02966080|WithdrawnDMC
Study Stopped
No participants enrolled, study will not be conducted.
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Sponsor study identifier
interventional
0
1 country
1
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 15, 2016
Actual (reported)November 17, 2016
Actual (reported)December 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
significant bleeding complications
requires surgery, \>1 unit packed blood cell transfusion or is intracranial, pulmonary or retroperitoneal
intraoperative
Oxygenator failure
intraoperative
cerebral vascular event (stroke)
intraoperative
Patients in this arm of the study will receive intravenous unfractionated heparin at a dose adjusted to achieve an activated clotting time of 180-200 seconds.
Patients in this arm of the study will receive intravenous unfractionated heparin at 500 units/hour without activated clotting time monitoring.
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Esper SA, Levy JH, Waters JH, Welsby IJ. Extracorporeal membrane oxygenation in the adult: a review of anticoagulation monitoring and transfusion. Anesth Analg. 2014 Apr;118(4):731-43. doi: 10.1213/ANE.0000000000000115.
Poulos EM, Raschke R, Amabile O et al. A Nonrandomized comparison of three different heparin infusion strategies for patients receiving venovenous extracorporeal membrane oxygenation. Am J Respir Crit Care Med 2014;189: A4499.
Robert Raschke, MD
Banner University Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2016
First Posted
November 17, 2016
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
Contact the study team to confirm eligibility.
Primary Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 21, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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