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    SARS-CoV-2 infection and venous thromboembolism after surgery: an international prospective cohort study

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    SARS-CoV-2 has been associated with an increased rate of venous thromboembolism in critically ill patients. Since surgical patients are already at higher risk of venous thromboembolism than general populations, this study aimed to determine if patients with peri-operative or prior SARS-CoV-2 were at further increased risk of venous thromboembolism. We conducted a planned sub-study and analysis from an international, multicentre, prospective cohort study of elective and emergency patients undergoing surgery during October 2020. Patients from all surgical specialties were included. The primary outcome measure was venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1-6 weeks before surgery); previous (>= 7 weeks before surgery); or none. Information on prophylaxis regimens or pre-operative anti-coagulation for baseline comorbidities was not available. Postoperative venous thromboembolism rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2. After adjustment for confounding factors, patients with peri-operative (adjusted odds ratio 1.5 (95%CI 1.1-2.0)) and recent SARS-CoV-2 (1.9 (95%CI 1.2-3.3)) remained at higher risk of venous thromboembolism, with a borderline finding in previous SARS-CoV-2 (1.7 (95%CI 0.9-3.0)). Overall, venous thromboembolism was independently associated with 30-day mortality (5.4 (95%CI 4.3-6.7)). In patients with SARS-CoV-2, mortality without venous thromboembolism was 7.4% (319/4342) and with venous thromboembolism was 40.8% (31/76). Patients undergoing surgery with peri-operative or recent SARS-CoV-2 appear to be at increased risk of postoperative venous thromboembolism compared with patients with no history of SARS-CoV-2 infection. Optimal venous thromboembolism prophylaxis and treatment are unknown in this cohort of patients, and these data should be interpreted accordingly

    The SvO2 Study: General design and results of the feasibility phase of a multicenter, randomized trial of three different hemodynamic approaches and two monitoring techniques in the treatment of critically ill patients

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    Although the attainment of normal hemodynamic values has always been assumed to be the therapeutic target for critically ill patients, recent studies reported increased values in oxygen transport variables in survivors of high-risk surgery. It has been supposed that the higher values observed in survivors might indicate a physiological compensation for the increased metabolic requirements due to disease. We designed a randomized, multicentric trial to evaluate the effect of high values of cardiac index (CI) and oxygen delivery (DO2) in critically ill patients. Patients enrolled in the study are randomized to three different hemodynamic targets: normal values of CI (2.5 or = 4.5 L min-1 m-2), and mixed venous oxygen saturation (SvO2) > or = 70% or (Sat a--Sat v) < or = 20%. Two different monitoring systems are used to maintain the target: conventional Swan-Ganz catheter with scheduled samples of mixed venous O2 saturation, and optical catheter with continuous SvO2 evaluation. The aim of the study is to answer three questions regarding the hypothesis reported above: (1) Are results in postoperative patients applicable to other pathological groups? (2) Does continuous monitoring of SvO2 provide advantages over conventional hemodynamic monitoring? (3) Is a normal SvO2 rather than a supranormal CI a good and predictable therapeutic goal? We report herein the protocol of the study and the results of the pilot phase, which was conducted in 98 critically ill patients enrolled by 56 participating centers to evaluate the safety and feasibility of the proposed trial
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