Table 2 SAE/withdrawal/exclusion
ITT/PP | Allocation [duration] | SAE/withdrawal/exclusion | Outcome |
|---|---|---|---|
ITT | Placebo [0 h] | Recovery with extubation before trial drug administration (incl. criteria not met). Excluded | Death on day 13 (resp. failure) |
ITT | Placebo [14 h] | Thrombosis in the arterial cannula (difficult insertion in Aa. radialis, instead US-guided insertion in a. brachialis). SAE/withdrawal | LMWH treatment (10.000 IE) with good effect. Survivor |
ITT | Placebo [14 h] | Indication for Flolan inhalation (severe respiratory failure). SAE/withdrawal | Death on day 2 (respiratory failure) |
PP | Placebo [completed] | Iatrogenic pneumothorax and intraabdominal bleeding after liver abscess drainage, 28 h after ceasing trial drug. SAE | Death on day 2 (pneumonia) |
ITT | Active [0 h] | Indication for acute abdominal surgery before trial drug administration. Excluded | Survivor |
ITT | Active [21 h] | Indication for therapeutic LMWH (suspicion of type II MI). Cardiac enzymes elevated before inclusion, but increasing. SAE/withdrawal | Death on day 10 (cardiac failure) |
ITT | Active [28 h] | Transferred to other ICU due to overcrowding. Withdrawal | Survivor |
PP | Active [complete] | Severe septic shock (Capnocytophagus carnimorsus) with bradycardia treated with 1 mg adrenalin IV and 2 min CPR. Circulatory stabilised after 2 min. Transferred to tertiary ICU day 4. Necrotomy of the face and leg day 27. Finger amputation (1., 2., 4., 5. finger on the left hand) day 35. Femur amputation day 50. SAE | Survivor |