Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation in ICU Patients With COVID-19
INSPIRATION trial design and results
Design
Multicentre randomised clinical trial
Treatment
Intermediate-dose prophylactic anticoagulation
Control
Standard-dose prophylactic anticoagulation
Population
562 analysed patients admitted to intensive care with COVID-19, median age 62, 42.2% women
Follow-up
30 days
Primary endpoint
Composite of adjudicated venous or arterial thrombosis, ECMO treatment, or mortality within 30 days
Result
The primary composite occurred in 126 of 276 (45.7%) on intermediate dose and a similar proportion on standard dose, with no significant difference. Major bleeding occurred in 7 (2.5%) on intermediate-dose versus 4 (1.4%) on standard-dose prophylaxis, and severe thrombocytopenia in 6 versus none (p=0.01).
Secondary endpoints
Major bleeding, severe thrombocytopenia, all-cause mortality
Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19.
The trial authors, in the published abstract
How it has aged
Concordant with REMAP-CAP anticoagulation at the therapeutic end of the dose range. Between them they closed off empirical anticoagulation escalation in critical COVID-19, at every dose above standard prophylaxis.
Publications
Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial
Sadeghipour P, Talasaz AH, Rashidi F, et al. Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial. JAMA 2021 Apr 27;325(16):1620-1630.
No difference in the composite of thrombosis, ECMO or death