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

NCT ID: NCT02966080

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-02-28

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.

Conditions

Acute Respiratory Failure; Extracorporeal Membrane Oxygenation Complication; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Adjusted-dose heparin

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.

Group Type: OTHER

HEP-IV

Intervention Type: DRUG

Fixed low-dose heparin

Patients in this arm of the study will receive intravenous unfractionated heparin at 500 units/hour without activated clotting time monitoring.

Group Type: OTHER

HEP-IV

Intervention Type: DRUG

Interventions

HEP-IV

Intervention Type: DRUG

Other Intervention Names

heparin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Robert Raschke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Raschke, MD

Role: PRINCIPAL_INVESTIGATOR

Banner University Medical Center

Locations

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24651227 (View on PubMed)

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.

Reference Type: BACKGROUND

Related Links

http://www.elso.org

ELSO anticoagulation guideline

Other Identifiers

1609884386

Identifier Type: -

Identifier Source: org_study_id