Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.

Bleeding Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02966080
• Other study ID #: 1609884386
• Status: Withdrawn
• Phase: N/A
• First received: November 15, 2016
• Last updated: August 16, 2017
• Start date: December 2016
• Est. completion date: February 2021

Study information

• Verified date: August 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Bleeding
• Extracorporeal Membrane Oxygenation Complication
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Drug:
• HEP-IV

Locations

Country	Name	City	State
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant bleeding complications	requires surgery, >1 unit packed blood cell transfusion or is intracranial, pulmonary or retroperitoneal	intraoperative
Secondary	Oxygenator failure	Requirement to replace oxygenator due to clotting	intraoperative
Secondary	cerebral vascular event (stroke)		intraoperative

External Links

•   ELSO anticoagulation guideline