Strategies for Anticoagulation During Venovenous ECMO (SAFE-ECMO)
Acute Hypoxemic Respiratory Failure, Anticoagulant-induced Bleeding, Thromboembolism
About this trial
This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring ARDS, Hypoxemic respiratory failure, Extracorporeal Membrane Oxygenation
Eligibility Criteria
Inclusion Criteria:
- Patient receiving V-V ECMO
- Patient is located in a participating unit of the Vanderbilt University Medical Center (VUMC) adult hospital.
Exclusion Criteria:
- Patient is pregnant
- Patient is a prisoner
- Patient is < 18 years old
- Patient underwent ECMO cannulation greater than 24 hours prior to screening
Presence of an indication for systemic anticoagulation:
- Ongoing receipt of systemic anticoagulation
- Planned administration of anticoagulation for an indication other than ECMO
- Presence of or plan to insert an arterial ECMO cannula
Presence of a contraindication to anticoagulation:
- Active bleeding determined by treating clinicians to make anticoagulation unsafe
- Major surgery or trauma less than 72 hours prior to randomization
- Known history of a bleeding diathesis
- Ongoing severe thrombocytopenia (platelet count < 30,000)
- History of heparin-induced thrombocytopenia (HIT)
- Heparin allergy
- Positive SARS-CoV-2 test within prior 21 days or high clinical suspicion for COVID-19
- The treating clinician determines that the patient's risks of thromboembolism or bleeding necessitate a specific approach to anticoagulation management during V-V ECMO
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Low Intensity Anticoagulation
Moderate Intensity Anticoagulation
For patients assigned to the low intensity anticoagulation strategy, clinical teams will be instructed to initiate low intensity anticoagulation at doses and frequencies commonly used for deep vein thrombosis (DVT) prophylaxis. The choice of anticoagulant, dose, and frequency of administration will be deferred to treating clinicians.
For patients assigned to the moderate intensity anticoagulation group, clinical teams will be instructed to initiate a continuous infusion of moderate intensity anticoagulation targeting either a partial thromboplastin time (PTT) of 40-60 seconds or an Anti-Xa level of 0.2 to 0.3 IU/mL. The choice of anticoagulant and approach to dosing will be deferred to treating clinicians.