Table 3. Adverse Events in a Study of Lower Tidal Volume Facilitated by Extracorporeal Carbon Dioxide Removal in Patients With Acute Hypoxemic Respiratory Failure.
| Adverse event | ECCO2R (n = 202) | Ventilation alone (n = 210) | ||
|---|---|---|---|---|
| No. of events | No. (%) of patients | No. of events | No. (%) of patients | |
| Adverse eventsa | 168 | 106 (52.5) | 61 | 48 (22.9) |
| Related to study interventiona,b | 65 | 51 (25.3) | 0 | 0 |
| Serious adverse eventsc,d | 70 | 62 (30.7) | 20 | 18 (8.6) |
| Related to study interventionb | 22 | 21 (10.4) | 0 | 0 |
| Adverse events of specific interest | ||||
| Bleeding at other site (excluding intracranial hemorrhage) | 18 | 17 (8.4) | 3 | 3 (1.4) |
| Intracranial hemorrhage | 10 | 10 (5.0) | 2 | 2 (1.0) |
| Device failure causing adverse event | 9 | 9 (4.5) | 0 | 0 |
| Bleeding at cannula site | 8 | 8 (4.0) | 0 | 0 |
| Infectious complicationse | 7 | 7 (3.5) | 1 | 1 (0.5) |
| Heparin-induced thrombocytopenia | 4 | 4 (2.0) | 0 | 0 |
| Hemolysis | 3 | 3 (1.5) | 0 | 0 |
| Ischemic stroke | 1 | 1 (0.5) | 3 | 3 (1.4) |
| Serious adverse events of specific interest f | ||||
| Bleeding at other site (excluding intracranial hemorrhage) | 6 | 6 (3.0) | 1 | 1 (0.5) |
| Intracranial hemorrhage | 9 | 9 (4.5) | 0 | 0 |
| Infectious complicationse | 5 | 5 (2.5) | 0 | 0 |
| Device failure causing serious adverse event | 2 | 2 (1.0) | 0 | 0 |
| Heparin-induced thrombocytopenia | 1 | 1 (0.5) | 0 | 0 |
| Ischemic stroke | 1 | 1 (0.5) | 3 | 3 (1.4) |
Abbreviation: ECCO2R, extracorporeal carbon dioxide removal.
Adverse event totals include serious adverse events.
A list of adverse events that were defined as related to the study intervention was provided in the study protocol (Supplement 1). Events that were possibly, probably, or definitely related to the study intervention (or were not assessable) were defined as related.
Serious adverse events defined by the System Organ Class can be found in eTable 7 in Supplement 4.
A serious adverse event was defined as any adverse event that led to death or resulted in a life-threatening illness or injury, permanent impairment of a body structure or a body function, patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or function, fetal distress, fetal death, or a congenital abnormality or birth defect.
Infectious complications were determined by the site investigator.
There were no episodes of hemolysis or bleeding at cannula site reported as serious adverse events.