Clinical trial NCT02966080: Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.
Official title: Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Respiratory Failure
Extracorporeal Membrane Oxygenation Complication
Bleeding
Keywords: extracorporeal membrane oxygenation
intravenous heparin
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Intravenous heparin is considered standard therapy to prevent clotting complications in patients on ECMO, however the optimal method of heparin dosing has not yet been determined. International surveys have shown that most ECMO centers use adjusted dose heparin to achieve an activated clotting time of at least 180 seconds. However, heparin may contribute to the most common complication of ECMO - bleeding. Advances in material technology have potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting complications. We intend to perform a randomized controlled trial in adults receiving venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding complications and oxygenator failure due to clotting. A safety committee will monitor the results of the study. Power calculations indicate a sample size of 110 patients is required, which we estimate will take us five years to achieve.

Eligibility criteria: Inclusion Criteria:

* on ECMO for acute respiratory failure, achieving ECMO blood flow rate \>3L/min,
* patient or surrogate able to speak/understand English or Spanish

Exclusion Criteria:

* History of heparin-induced thrombocytopenia, decision by clinicians to run ECMO off heparin due to high bleeding risk,
* pregnancy

Primary outcomes:
measure: significant bleeding complications
timeFrame: intraoperative
Secondary outcomes:
measure: Oxygenator failure
timeFrame: intraoperative
measure: cerebral vascular event (stroke)
timeFrame: intraoperative
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Robert Raschke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.