Anticoagulation-free VV ECMO for Acute Respiratory Failure
A-FREE ECMO
1 other identifier
interventional
40
1 country
1
Brief Summary
Currently international experts recommend therapeutic anticoagulation for veno-venous extracorporeal membrane oxygenation (VV-ECMO). Reports and case series suggest that the absence of therapeutic anticoagulation is safe for VV-ECMO. No randomized control trials have assessed this. The aim of this pilot study is to assess safety and feasibility of an "anticoagulation-free strategy" for veno-venous ECMO (VV-ECMO) in Acute respiratory distress syndrome (ARDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
January 16, 2026
January 1, 2026
4.3 years
February 11, 2020
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ECMO associated thrombotic complications
Composite outcome of: * ECMO membrane oxygenator function assessed by trans-membrane pressure drop (\> 10mmHg/l/min) and a membrane PaO2/FiO2 ratio (\< 200mmHg) * Need to change ECMO circuit due to clotting or dysfunction * Platelets drop \>50% in 24 hours and \<50 /mm3 * Development of a clinically significant thromboembolic event * Clinical deep vein thrombosis, clinically suspected and confirmed by ultrasound * Acute ischemic stroke, clinically suspected and confirmed by head-CT
through ECMO completion, an average of 14 days
Secondary Outcomes (1)
Hemorrhagic complications
through ECMO completion, an average of 14 days
Other Outcomes (4)
Increase in d-dimer levels
through ECMO completion, an average of 14 days
Transfusion of blood and blood-derived products related or not to a bleeding event
through ECMO completion, an average of 14 days
Coagulation parameters on ECMO
through ECMO completion, an average of 14 days
- +1 more other outcomes
Study Arms (2)
No anticoagulation
EXPERIMENTALParticipants in this arm will not receive unfractionated heparin during the course of ECMO. They will receive standard venous thromboembolism prophylaxis with subcutaneous enoxaparin or unfractionated heparin
Anticoagulation, ECMO standard of care
NO INTERVENTIONParticipants in this arm will receive the standard of care anticoagulation with unfractionated heparin during the course of ECMO.
Interventions
The intervention group will receive prophylactic heparin instead of standard of care therapeutic intravenous heparin
Eligibility Criteria
You may qualify if:
- Adult patient with ARDS on VV-ECMO
You may not qualify if:
- Contraindication to anticoagulation with UFH (known heparin-induced thrombocytopenia, active hemorrhage, any surgery precluding the use of anticoagulation),
- Indication for therapeutic anticoagulation (pulmonary embolism or deep vein thrombosis, chronic anticoagulation therapy before ECMO insertion)
- Low-flow (\<2 liters/min) VV-ECMO (ECCO2R)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Damian Ratanolead
- The Physicians' Services Incorporated Foundationcollaborator
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Related Publications (9)
Krueger K, Schmutz A, Zieger B, Kalbhenn J. Venovenous Extracorporeal Membrane Oxygenation With Prophylactic Subcutaneous Anticoagulation Only: An Observational Study in More Than 60 Patients. Artif Organs. 2017 Feb;41(2):186-192. doi: 10.1111/aor.12737. Epub 2016 Jun 3.
PMID: 27256966BACKGROUNDWhittlesey GC, Drucker DE, Salley SO, Smith HG, Kundu SK, Palder SB, Klein MD. ECMO without heparin: laboratory and clinical experience. J Pediatr Surg. 1991 Mar;26(3):320-4; discussion 324-5. doi: 10.1016/0022-3468(91)90510-z.
PMID: 2030479BACKGROUNDWen PH, Chan WH, Chen YC, Chen YL, Chan CP, Lin PY. Non-heparinized ECMO serves a rescue method in a multitrauma patient combining pulmonary contusion and nonoperative internal bleeding: a case report and literature review. World J Emerg Surg. 2015 Mar 12;10:15. doi: 10.1186/s13017-015-0006-9. eCollection 2015.
PMID: 25774211BACKGROUNDDornia C, Philipp A, Bauer S, Stroszczynski C, Schreyer AG, Muller T, Koehl GE, Lehle K. D-dimers Are a Predictor of Clot Volume Inside Membrane Oxygenators During Extracorporeal Membrane Oxygenation. Artif Organs. 2015 Sep;39(9):782-7. doi: 10.1111/aor.12460. Epub 2015 Apr 7.
PMID: 25845704BACKGROUNDLubnow M, Philipp A, Dornia C, Schroll S, Bein T, Creutzenberg M, Diez C, Schmid C, Pfeifer M, Riegger G, Muller T, Lehle K. D-dimers as an early marker for oxygenator exchange in extracorporeal membrane oxygenation. J Crit Care. 2014 Jun;29(3):473.e1-5. doi: 10.1016/j.jcrc.2013.12.008. Epub 2013 Dec 30.
PMID: 24508200BACKGROUNDLehle K, Philipp A, Gleich O, Holzamer A, Muller T, Bein T, Schmid C. Efficiency in extracorporeal membrane oxygenation-cellular deposits on polymethylpentene membranes increase resistance to blood flow and reduce gas exchange capacity. ASAIO J. 2008 Nov-Dec;54(6):612-7. doi: 10.1097/MAT.0b013e318186a807.
PMID: 19033775BACKGROUNDSidebotham D, Allen SJ, McGeorge A, Ibbott N, Willcox T. Venovenous extracorporeal membrane oxygenation in adults: practical aspects of circuits, cannulae, and procedures. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):893-909. doi: 10.1053/j.jvca.2012.02.001. Epub 2012 Apr 13. No abstract available.
PMID: 22503344BACKGROUNDLubnow M, Philipp A, Foltan M, Bull Enger T, Lunz D, Bein T, Haneya A, Schmid C, Riegger G, Muller T, Lehle K. Technical complications during veno-venous extracorporeal membrane oxygenation and their relevance predicting a system-exchange--retrospective analysis of 265 cases. PLoS One. 2014 Dec 2;9(12):e112316. doi: 10.1371/journal.pone.0112316. eCollection 2014.
PMID: 25464516BACKGROUNDPanigada M, E Iapichino G, Brioni M, Panarello G, Protti A, Grasselli G, Occhipinti G, Novembrino C, Consonni D, Arcadipane A, Gattinoni L, Pesenti A. Thromboelastography-based anticoagulation management during extracorporeal membrane oxygenation: a safety and feasibility pilot study. Ann Intensive Care. 2018 Jan 16;8(1):7. doi: 10.1186/s13613-017-0352-8.
PMID: 29340875BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damian Ratano, MD
University Health Network, Toronto
- PRINCIPAL INVESTIGATOR
Eddy Fan, MD, PhD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 18, 2020
Study Start
September 1, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share