Table 2 Serious adverse event (SAE) of the TRAIN study
SAE | Definition |
|---|---|
Severe hypertension | Mean arterial pressure (MAP) > 130 mmHg for more than 1 h and needing active therapy, in the absence of vasopressor agents and increased intracranial hypertension |
Severe hypotension | MAP < 65 mmHg for at least > 1 h, not responding to fluid therapy and needing vasopressor therapy, in the absence of active bleeding |
Venous thrombotic events | Deep vein thrombosis (formation of a blood clot within a deep vein in the legs or arms, which may be associated with non-specific signs, such as pain, swelling, redness, warmness, and engorged superficial veins—it can be diagnosed either by echography, venography, or CT imaging); pulmonary embolism (formation of a clot within the pulmonary arterial circulation, diagnosed by contrast pulmonary CT scan or echocardiography) |
Acute myocardial ischemia | Acute myocardial infarction (ST-elevation and non-ST-elevation myocardial infarction) or unstable chest pain diagnosed during current hospital admission, according to specific criteria (i.e., elevated biomarkers of myocardial injury, ischemic signs on ECG, clinical suspicion) and the patient has received specific treatment (reperfusion strategies such as percutaneous coronary intervention [PCI] or thrombolysis) or initiation/increase of antithrombotic drug treatment during current ICU admission |
Intestinal ischemia | Ischemic lesions confirmed by endoscopy and/or open surgery |
Acute peripheral limb ischemia | Clinical signs and the need for open or percutaneous vascular intervention, amputation, or initiation/increased antithrombotic treatment |
Anaphylactic reaction to RBC transfusion | Muco-cutaneous signs (i.e., urticaria, pruritus) and/or hemolytic anemia within 24 h after transfusion |
ARDS | Acute hypoxemia with bilateral infiltrates, according to recent definitions |
TRALI | ARDS occurring within 6 h after RBC transfusion |
TACO | Acute hypoxemia (PaO2/FiO2 < 300 regardless of positive end-expiratory pressure [PEEP]) with bilateral lung infiltrates and occurrence within 6 h after RBC transfusion and increased blood pressure and positive fluid balance |
Sepsis | Presence of an infection and organ failure attributed to it. Septic shock = arterial hypotension (MAP < 65 mmHg) despite adequate fluid resuscitation and necessitating vasopressor therapy |
Infections | According to CDC definitions |
Brain tissue hypoxia | For those patients with PbtO2 monitoring, values of < 20 mmHg for at least 1 h over the last 24 h |