Low-Intensity vs Moderate-Intensity Anticoagulation for Venovenous Extracorporeal Membrane Oxygenation: The Strategies for Anticoagulation During Venovenous Extracorporeal Membrane Oxygenation Pilot Trial.
Summary
In this multicenter pilot RCT (n=26), low-intensity vs moderate-intensity anticoagulation during vvECMO was feasible with complete protocol adherence. Major bleeding was less frequent with low-intensity anticoagulation (8.3% vs 28.6%), with similar thromboembolic events, supporting the feasibility of a larger efficacy trial.
Key Findings
- Feasibility established: all 26 randomized patients received the assigned anticoagulation intensity across 3 centers.
- Major bleeding was lower with low-intensity anticoagulation (8.3%) vs moderate-intensity (28.6%); P=0.33 (underpowered).
- Thromboembolic events were rare and similar (1 vs 0), and in-hospital mortality was 0% vs 14.3% (both deaths after major bleeding) in low vs moderate intensity.
Clinical Implications
Pending confirmatory trials, centers may consider evaluating lower-intensity anticoagulation protocols to balance bleeding and thrombosis risks during vvECMO.
Why It Matters
Addresses a critical management question for ARDS patients on vvECMO, with a signal that lower-intensity anticoagulation may reduce bleeding without clear increase in thrombosis.
Limitations
- Small pilot sample, underpowered for clinical endpoints
- Open-label design and limited generalizability across ECMO practices
Future Directions
Conduct a large, adequately powered multicenter RCT to test clinical outcomes, including bleeding, thrombosis, circuit complications, and mortality, and to define anticoagulation targets.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled pilot trial across multiple centers
- Study Design
- OTHER