N/A
N=26
Strategies for Anticoagulation During Venovenous ECMO
Acute Hypoxemic Respiratory Failure · Anticoagulant-induced Bleeding · Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT04997265 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Number of Participants With Major Bleeding Events — 1; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low intensity anticoagulation (Other); Moderate Intensity Anticoagulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Bleeding Events |
1; 4 | — |
| PRIMARY Number of Participants With Thromboembolic Events |
0; 1 | — |
| SECONDARY Number of Participants With Cannula-associated Deep Vein Thrombosis |
7; 5 | <0.05 sig |
| SECONDARY Number of Circuit or Circuit Component Exchanges |
2; 1 | — |
| SECONDARY New Heparin Induced Thrombocytopenia Diagnosis |
0; 0 | — |
| SECONDARY Lowest Platelet Count |
88; 130 | — |
| SECONDARY Highest Total Bilirubin Values |
1.2; 0.9 | — |
| SECONDARY Highest Lactate Dehydrogenase Value |
492; 711 | — |
| SECONDARY Death Attributable to a Major Bleeding Event |
0; 0 | — |
| SECONDARY Death Attributable to a Thromboembolic Event |
0; 0 | — |
| SECONDARY Ventilator-free Days |
54; 47 | — |
| SECONDARY ICU Length of Stay |
11; 15 | — |
| SECONDARY Hospital Length of Stay |
19; 23 | — |
| SECONDARY In-hospital Mortality |
2; 0 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT04997265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.