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001-es BibID:BIBFORM056495
Első szerző:Kakkar, Ajay K.
Cím:Preoperative enoxaparin versus postoperative semuloparin thromboprophylaxis in major abdominal surgery : a randomized controlled trial / Ajay K. Kakkar, Giancarlo Agnelli, William Fisher, Daniel George, Michael R. Lassen, Patrick Mismetti, Patrick Mouret, Judith Murphy, Francesca Lawson, Alexander G. G. Turpie, SAVE-ABDO Investigators
Dátum:2014
ISSN:0003-4932
Megjegyzések:OBJECTIVE: To compare efficacy and safety of thromboprophylaxis with semuloparin started postoperatively versus enoxaparin started preoperatively in major abdominal surgery. BACKGROUND: Venous thromboembolism is an important complication following major abdominal surgery. Semuloparin is a novel ultra-low-molecular-weight heparin with high antifactor Xa and minimal antifactor IIa activity. METHODS: In this double-blind noninferiority trial, adult patients undergoing major abdominal or pelvic operation under general anesthesia lasting more than 45 minutes were assigned to either daily enoxaparin 40 mg commenced preoperatively or daily semuloparin 20 mg commenced postoperatively, for 7 to 10 days. Patients underwent bilateral leg venography between 7 and 11 days postsurgery. The primary efficacy end point was the composite of any deep vein thrombosis, nonfatal pulmonary embolism, or all-cause death. The primary safety outcome was bleeding. Both were independently adjudicated. RESULTS: In total, 4413 patients were randomized; 3030 (1499 in the enoxaparin and 1531 in the semuloparin groups) were evaluable for the primary efficacy end point, which occurred in 97 patients (6.3%) in the semuloparin group and 82 patients (5.5%) in the enoxaparin group [odds ratio (OR) = 1.16, 95% confidence interval (CI): 0.84-1.59]. On the basis of a noninferiority margin of 1.25, postoperative semuloparin did not demonstrate noninferiority to preoperative enoxaparin. Major bleeding occurred in 63 of 2175 patients (2.9%) in the semuloparin group and 98 of 2177 patients (4.5%) in the enoxaparin group (OR = 0.63, 95% CI: 0.46-0.87).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Annals of Surgery. - 259 : 6 (2014), p. 1073-1079. -
További szerzők:Agnelli, Giancarlo Fisher, William George, Daniel Lassen, Michael R. Mismetti, Patrick Mouret, Patrick Murphy, Judith Lawson, Francesca Turpie, Alexander G. G. Damjanovich László (1960-) (általános sebész) SAVE-ABDO Investigators
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
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