18 and older, any sex, with Acute Hypoxemic Respiratory Failure or Anticoagulant-induced Bleeding. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Major Bleeding EventsPrimary· From randomization to the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days.
Major bleeding event, according to the International Society on Thrombosis and Hemostasis, defined as:
1. Fatal bleeding
2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome
3. Clinically overt bleeding associated with either a drop in hemoglobin level by at least 2.0 grams/dL or leading to transfusion of two or more units of packed red blood cells
Group
Value
95% CI
Low Intensity Anticoagulation
1
Moderate Intensity Anticoagulation
4
Number of Participants With Thromboembolic EventsPrimary· From randomization to the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days.
Number of Participants With Cannula-associated Deep Vein ThrombosisSecondary· 24-72 hours after decannulation
Cannula-associated deep vein thrombosis, as measured by four-extremity venous ultrasounds obtained 24-72 hours following decannulation among patients who were decannulation
Group
Value
95% CI
Moderate-intensity Anticoagulation
7
Low-intensity Anticoagulation
5
Number of Circuit or Circuit Component ExchangesSecondary· From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days
Circuit or circuit component exchange during ECMO support
Group
Value
95% CI
Moderate-intensity Anticoagulation
2
Low-intensity Anticoagulation
1
New Heparin Induced Thrombocytopenia DiagnosisSecondary· From randomization to the date of death or decannulation, whichever came first, through study completion, up to 134 days
New diagnosis of Heparin Induced Thrombocytopenia as measured by clinically obtained serotonin release assay
Group
Value
95% CI
Moderate-intensity Anticoagulation
0
Low-intensity Anticoagulation
0
Lowest Platelet CountSecondary· From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days
Lowest clinically obtained platelet count
Group
Value
95% CI
Moderate-intensity Anticoagulation
88
70 – 132
Low-intensity Anticoagulation
130
115 – 170
Highest Total Bilirubin ValuesSecondary· From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days
Highest clinically obtained total bilirubin values
Group
Value
95% CI
Low Intensity Anticoagulation
1.2
0.6 – 1.4
Moderate Intensity Anticoagulation
0.9
0.7 – 2.1
Highest Lactate Dehydrogenase ValueSecondary· From randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, up to 134 days
Highest clinically obtained lactate dehydrogenase value
Group
Value
95% CI
Moderate-intensity Anticoagulation
492
426 – 543
Low-intensity Anticoagulation
711
320 – 941
Death Attributable to a Major Bleeding EventSecondary· From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days
In-hospital mortality attributable to a major bleeding event
Group
Value
95% CI
Moderate-intensity Anticoagulation
0
Low-intensity Anticoagulation
0
Death Attributable to a Thromboembolic EventSecondary· From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days
In-hospital mortality attributable to a thromboembolic event
Group
Value
95% CI
Moderate-intensity Anticoagulation
0
Low-intensity Anticoagulation
0
Ventilator-free DaysSecondary· From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days
Number of days alive and free from mechanical ventilation between randomization and day 28.
Group
Value
95% CI
Moderate-intensity Anticoagulation
54
30 – 57
Low-intensity Anticoagulation
47
39 – 56
ICU Length of StaySecondary· From randomization to the date of death or discharge, whichever came first, through study completion, up to 134 days
Number of days in the ICU following randomization.
Group
Value
95% CI
Moderate-intensity Anticoagulation
11
6 – 20
Low-intensity Anticoagulation
15
7 – 25
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 18 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04997265.