©2022 Stanford Medicine
Strategies for Anticoagulation During Venovenous ECMO
Recruiting
Trial ID: NCT04997265
Purpose
Moderate intensity titrated dose anticoagulation has been used in patients receiving
extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic
mechanical complications. As technology has improved, however, the incidence of
thromboembolic events has decreased, leading to re-evaluation of the risks of
anticoagulation, particularly during venovenous (V-V) ECMO. Recent data suggest that bleeding
complications during V-V ECMO may be more strongly associated with mortality than
thromboembolic complications, and case series have suggested that V-V ECMO can be safely
performed without moderate or high intensity anticoagulation. At present, there is
significant variability between institutions in the approach to anticoagulation during V-V
ECMO. A definitive randomized controlled trial is needed to compare the effects of a low
intensity fixed dose anticoagulation (low intensity) versus moderate intensity titrated dose
anticoagulation (moderate intensity) on clinical outcomes during V-V ECMO. Before such a
trial can be conducted, however, additional data are needed to inform the feasibility of the
future trial.
Official Title
Strategies for Anticoagulation During Venovenous ECMO: The SAFE-ECMO Pilot Trial
Stanford Investigator(s)
Vikram Fielding-Singh
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine
Eligibility
Inclusion Criteria:
1. Patient receiving V-V ECMO
2. Patient is located in a participating unit of the Vanderbilt University Medical Center
(VUMC) adult hospital.
Exclusion Criteria:
1. Patient is pregnant
2. Patient is a prisoner
3. Patient is < 18 years old
4. Patient underwent ECMO cannulation greater than 24 hours prior to screening
5. Presence of an indication for systemic anticoagulation:
1. Ongoing receipt of systemic anticoagulation
2. Planned administration of anticoagulation for an indication other than ECMO
3. Presence of or plan to insert an arterial ECMO cannula
6. Presence of a contraindication to anticoagulation:
1. Active bleeding determined by treating clinicians to make anticoagulation unsafe
2. Major surgery or trauma less than 72 hours prior to randomization
3. Known history of a bleeding diathesis
4. Ongoing severe thrombocytopenia (platelet count < 30,000)
5. History of heparin-induced thrombocytopenia (HIT)
6. Heparin allergy
7. Positive SARS-CoV-2 test within prior 21 days or high clinical suspicion for COVID-19
8. The treating clinician determines that the patient's risks of thromboembolism or
bleeding necessitate a specific approach to anticoagulation management during V-V ECMO
Intervention(s):
other: Low intensity anticoagulation
other: Moderate Intensity Anticoagulation
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305