Patient safety thromboembolism

Middle Cerebral Artery Occlusion and the PROACT Trial The safety and efficacy of lAT in the anterior circulation have been evaluated in two randomized, multicenter, placebo-controlled trials. In the Prolyse in Acute Cerebral Thromboembolism (PROACT) 1 and 11 trials, patients with proximal MCA (Ml or M2 segment) occlusions within 6 hours of symptom onset were treated with recombinant prourokinase (r-pro-UK) or placebo. ... 

The convenience (and cost-effectiveness) of LMW heparin therapy has resulted in widespread changes in practice. Patients with acute venous thromboembolism can be treated safely and effectively with LMW heparin as outpatients. Large-scale studies have demonstrated that outpatient treatment of acute deep vein thrombosis (DVT) with unmonitored body-weight adjusted LMW heparin is as safe and effective as inpatient treatment with adjusted dose intravenous standard heparin. Further trials have confirmed the safety and efficacy of LMW heparin therapy in acute pulmonary embolism and that 80% of imselected patients with acute thromboembolism can be safely treated as outpatients. ... 

Case-control studies have been used extensively to assess the safety of pharmaceuticals. There are many examples of case-control studies that have identified important associations between drugs and adverse health events vaginal cancer and diethylstilbestrol, Reye s syndrome and aspirin, peptic ulcer disease and nonsteroidal antiinflammatory drugs, and venous thromboembolism and oral contraceptives. Data from case-control studies are used to calculate an odds ratio, which is the ratio of the odds of developing the disease for exposed patients to the odds of developing the disease for unexposed patients. 

The primary study end-point was incidence of DVT and other thromboembolic events assessed clinically and by both locally and centrally assessed ultrasonography. The duplex-ultrasounds of the lower extremities were used to confirm or exclude the occurrence of DVT. These procedures were performed and interpreted by qualified specialists within the same hospi-tal/institution on a real-time basis for the timely and appropriate chnical care of the patient Furthermore, duplex ultrasound studies were videotaped for a subsequent standardized bhnded interpretation by a quahfied, independent laboratory that provided an unbiased evaluation of the incidence of DVT. ThromboemboHc events other than DVT that occurred during the study period were assessed, and the investigator estabhshed the clinical relationship of the event to treatment with rhAT. Secondary end-points were safety, adverse events and immunogenicity. 

Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States. Persons with Afib are at increased risk of blood clots in the heart that in turn may lead to thromboembolic stroke. The medication warfarin is often prescribed as a preventative measure. While the effectiveness of warfarin in the prevention of thromboembolic stroke is well established, its physiological mechanism of action also puts users at higher risk for other adverse events, for example, bleeding, whose health consequences may be just as devastating. Randomized clinical trials of warfarin have reported favorable results in both effectiveness and safety analyses. However, some clinicians have expressed doubt as to whether these results validly represent the situation in the general Afib patient population. The reason is that typical Afib patients tend to have more comorbidities and may not be as healthy as trial participants. 

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