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. 2009 Feb 27;4(2):e4644. doi: 10.1371/journal.pone.0004644

Table 4. Definition of secondary clinical study outcomes to be used if a large multicentre trial is conducted.

Deep vein thrombosis Any clinical suspicion of deep vein thrombosis (lower limb pain OR tenderness OR swelling OR edema) AND objective diagnostic confirmation (positive lower limb venogram with constant intraluminal filling defect seen on ≥2 views OR compression ultrasound demonstrating a noncompressible vein segment)
Pulmonary embolus Any clinical suspicion of pulmonary embolus (chest pain OR shortness of breath) AND objective diagnostic confirmation
1) definite pulmonary embolus = a pulmonary angiogram with a constant intraluminal filling defect OR a spiral computed tomogram with an unenhanced filling defect seen in a central pulmonary artery OR a high-probability ventilation-perfusion scan OR an intermediate ventilation-perfusion scan with venographic evidence of deep vein thrombosis OR autopsy evidence of pulmonary embolus
2) probable pulmonary embolus = an intermediate ventilation-perfusion scan with clinical signs
Transient ischemic attack Any new focal neurological deficit of vascular origin that lasts <24 h with no permanent neurological sequelae
Stroke Any new focal neurological deficit of vascular origin with signs and symptoms lasting ≥24 h
Congestive heart failure Any condition with both clinical (elevated jugular venous pressure OR respiratory rales OR crepitations OR presence of S3) AND radiological (vascular redistribution OR interstitial pulmonary edema OR frank pulmonary edema) evidence consistent with congestive heart failure
Clinically important bradycardia Heart rate <60 bpm requiring temporary pacing, a sympathomimetic agent, or atropine
Clinically important hypotension Systolic blood pressure that is at least 20% lower than the preoperative systolic blood pressure AND requires fluid resuscitation, a vasopressor, or an inotropic agent