Cook et al70/2008 (DIRECT)
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Multicenter prospective cohort
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138 Medical-surgical ICU patients with renal insufficiency
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Dalteparin 5,000 International Units SC daily
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Daily bedside clinical assessment using ICU bleeding tool
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Up to 30 d
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Increased INR HR for 0.5-unit difference, 1.68 (95% CI, 1.07-2.66)
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Independent variables: baseline characteristics,a type of dialysis, INR, aPTT, platelet count, and within preceding 3 d: therapeutic heparin treatment, prophylactic dalteparin, detectable trough anti-Xa level, any dose of aspirin
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Arnold et al68/2007 |
Single-center prospective cohort |
100 Consecutive medical-surgical ICU patients |
None. Daily bleeding assessment done in duplicate by blinded, trained assessors |
Fatal bleeding: bleeding causing death. Major bleeding: bleeding causing severe physiologic derangements, occurred at a critical site, or required therapeutic intervention. Minor bleeding: bleeding not meeting criteria for major bleeding |
During ICU stay until discharge, death, or 90 d |
Most major bleeding events were GI; 90% of patients experienced 480 bleeding events; 94.8% minor and 5.2% major. HRs (95% CI) for predictors of major bleeding: prolonged aPTT 1.2 (1.1-1.3) for every 10 s increase, decrease in platelet count 1.7 (1.2-2.3) for every 50 × 109/L decrease |
Risk factors included in the model: admission diagnosis, APACHE II score, platelet count, coagulation parameters, use of prophylactic or therapeutic doses of UFH or LMWH, use of antiplatelet agents, need for dialysis |