ImportanceThere remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA).ObjectiveTo determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA.Design, Setting, and ParticipantsCluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021.InterventionsHospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation.Main Outcomes and MeasuresThe primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group.ResultsEnrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group.Conclusions and RelevanceAmong patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis.Trial RegistrationANZCTR Identifier: ACTRN12618001879257
From the Departments of Surgery and Radiology, Clinical Sciences Building, Leicester Royal Infirmary, Leicester SUMMARY One hundred and two patients with acute pancreatitis had abdominal computed tomography (CT) scans within 72 hours of admission, at one week and at six weeks. Twenty eight attacks were clinically severe, 74 clinically mild. Ninety three (91%) admission scans, 85 (84%) one week scans, and 52 (51%) six week scans were abnormal. The aetiology of the pancreatitis could be inferred from 28 (27%) of admission scans, the CT sign of fatty liver having a sensitivity of 21% and specificity of 100% for alcoholic aetiology. The sensitivity of CT for gall stone aetiology was 34%, specificity 100%. The pancreatic size indices (max anteroposterior measurement of headXmax anteroposterior measurement of body) of those patients with severe attacks were significantly greater than those with mild attacks on admission, at one week and at six weeks (p<0004). Fourteen pseudocysts were detected by CT, five (36%) of which were clinically apparent. The pseudocyst size indices (max anteroposteriorxmax transverse measurement) of the pseudocysts which were clinically apparent were significantly greater than those which were not apparent (p<0O01) and only those pseudocysts with a size index 3 15 cm2 required treatment.Although there have been numerous studies of CT scanning in acute pancreatitis, there have not been any reports of serial CT scanning of the disease. The purpose of this prospective study was to obtain CT scans of patients with acute pancreatitis on admission to hospital, at one week, and at six weeks and to thereby document the natural history of the local disease process. We also wished to study the ability of CT to diagnose acute pancreatitis and its local complications and to compare the serial CT appearances of the pancreata of those patients with mild and severe attacks. pancreatitis was based on a serum amylase of greater than 1000 IU/I (Phadebas Method) in the presence of a compatible clinical picture. Computed tomography scans were done within 72 hours of admission, at one week and at six weeks. All scans were done on a GE 8800 scanner and reported 'blind' by a single consultant radiologist. The admission scan consisted of a plain abdominal scan followed by a contrastenhanced scan taking 10 mm contiguous cuts during an intravenous infusion of 100 ml Niopam 370. The one week and six week scans were not contrast enhanced. Pancreatic enhancement on the admission scan was defined as increased, normal or decreased compared with the enhancement of the liver and spleen. It was noted for all scans whether there was loss of peripancreatic tissue planes and the maximum anteroposterior measurement (in centimetres) of the pancreatic head, body, and tail were recorded. These measurements were taken opposite the right hand border of the lumbar vertebrae, the left hand border of the aorta and the left renal hilum respectively. The measurements from 50 scans were repeated by an independent observer in order to determi...
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