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Essentials Cancer patients receiving anticoagulants for venous thromboembolism have an elevated bleeding risk. This secondary analysis of CATCH assessed characteristics of clinically relevant bleeding (CRB). CRB occurs in 15% of cancer patients with thrombosis using therapeutic doses of anticoagulation. After multivariate analysis, risk factors for CRB were age >75 years and intracranial malignancy. Summary Background Cancer patients with acute venous thromboembolism (VTE) receiving anticoagulant treatment have an increased bleeding risk. Objectives We performed a prespecified secondary analysis of the randomized, open-label, Phase III CATCH trial (NCT01130025) to assess the rate and sites of and the risk factors for clinically relevant bleeding (CRB). Patients/Methods Patients with active cancer and acute, symptomatic VTE received either tinzaparin 175 IU kg-1 once daily or warfarin (target International Normalized Ratio [INR] of 2.0-3.0) for 6 months. Fisher's exact test was used to screen prespecified clinical risk factors; those identified as being significantly associated with an increased risk of CRB then underwent competing risk regression analysis of time to first CRB. Results Among 900 randomized patients, 138 (15.3%) had 180 CRB events. CRB occurred in 60 patients (81 events) in the tinzaparin group and in 78 patients (99 events) in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.45-0.89). Common bleeding sites were gastrointestinal (36.7%; n = 66), genitourinary (22.8%; n = 41), and nasal (10.0%; n = 18). In multivariate analysis, the risk of CRB increased with age > 75 years (HR 1.83, 95% CI 1.14-2.94) and intracranial malignancy (HR 1.97, 95% CI 1.07-3.62). In the warfarin group, 40.4% of CRB events occurred in patients with with an INR of 75 years and intracranial malignancy.

The inflammatory reactions and tissue response after oesophagectomy are leading causes of postoperative morbidity and mortality. We evaluated the effects of intraoperative infusion of prostaglandin E1 (PGE1) on interleukin-6 (IL-6) levels, (A-a) DO2, pulmonary function and complications. This randomised double-blind clinical trial study was performed on patients undergoing transthoracic oesophagectomy due to cancer. Thirty patients were randomly allocated to two groups: the PGE1 group (infusion of PGE1, 20 ng.kg−1.min−1) and a placebo group (infusion of normal saline 0.9%). The infusion was started before induction of anaesthesia and continued until the end of the operation. The groups were comparable in basic characteristics and preoperative pulmonary function. Patients in the PGE1 group were discharged significantly earlier from the intensive care unit (72±9 vs 83±17 hours) and hospital (13±4 vs 18±8 days) (P=0.04 and 0.03, respectively). The (A-a) DO2 was significantly less in the PGE1 group at 12 and 24 hours after the operation (P=0.001, P=0.003, respectively). Postoperatively, IL-6 levels were significantly higher in the placebo group than in the PGE1 group. There were no differences in the forced expiratory volume in the first second or forced vital capacity. The findings indicate that infusion of PGE1 attenuates the increase in serum levels of IL-6 in patients undergoing esophagectomy and improves the (A-a) DO2. Stays in the intensive care unit and hospital were shorter in the PGE1 group. However, there were no differences in pulmonary complications.