Anticoagulation-free VV ECMO for Acute Respiratory Failure
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDamian Ratano
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient with ARDS on VV-ECMO
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Subcutaneous Heparin
DrugThe intervention group will receive prophylactic heparin instead of standard of care therapeutic intravenous heparin
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: No anticoagulationExperimental treatment 1 intervention
Group B: Anticoagulation, ECMO standard of careNo intervention 0 interventions
Trial outcomes
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
Time frame
through ECMO completion, an average of 14 daysSecondary outcomes
1
Hemorrhagic complications
Hemorrhagic complications assessed and adapted as per Bleeding Academic Research Consortium (BARC) * Type 0: No bleeding * Type 1: Bleeding requiring transfusion of packed red blood cells (PRBC) or reduction of UFH * Type 2: Bleeding requiring transfusion of PRBC and reduction of UFH * Type 3: Life-threatening bleeding requiring, transfusion of PRBC, surgical intervention or discontinuation of ECMO * Type 4: Any fatal bleeding
Time frame
through ECMO completion, an average of 14 daysOther outcomes
1
Increase in d-dimer levels
D-dimers level (\>5000ng/ml or \>50% increase in 24 h) * Need for transfusion of blood and blood-derived products related or not to a bleeding event * Coagulation parameters during the ECMO period * Amount of clot and fibrin visualized in the pre- and post-membrane side of the oxygenator daily (visual assessment) and after ECMO removal (assessed by a photographic quantification method).
Time frame
through ECMO completion, an average of 14 days2
Transfusion of blood and blood-derived products related or not to a bleeding event
Amount of blood products transfused to patients in each groups during the course of ECMO
Time frame
through ECMO completion, an average of 14 days3
Coagulation parameters on ECMO
Evaluation of fibrinogen (g/l), activated partial thromboplastin time (aPTT, seconds), prothrombin time (PT, seconds), thromboelastogram (if available), activated clotting time (ACT, seconds; if available)
Time frame
through ECMO completion, an average of 14 days4
Amount of clot and fibrin visualized in the pre- and post-membrane side
Pragmatic quantification of clot visualized on both sides of the oxygenator by direct evaluation and by a photographic quantification method
Time frame
through ECMO completion, an average of 14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Damian Ratano
Lead sponsor
University Health Network, Toronto
Sponsor institution
The Physicians' Services Incorporated Foundation
Collaborator
Source ClinicalTrials.gov