International multicentre trial protocol to assess the efficacy and safety of tenecteplase during cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest: the Thrombolysis in Cardiac Arrest (TROICA) Study.

Prehospital cardiac arrest has been associated with a very poor prognosis. Acute myocardial infarction and massive pulmonary embolism are the underlying causes of out-of-hospital cardiac arrest in 50-70% of patients. Although fibrinolysis is an effective treatment strategy for both myocardial infarction and pulmonary embolism, clinical experience for this therapy performed during resuscitation has been limited owing to the anticipated risk of severe bleeding complications. The TROICA study is planned as one of the largest randomized, double-blind, placebo-controlled trials to assess the efficacy and safety of prehospital thrombolytic therapy in cardiac arrest of presumed cardiac origin. Approximately 1000 patients with cardiac arrest will be randomized at approximately 60 international study centres to receive either a weight-adjusted dose of tenecteplase or placebo after the first dose of a vasopressor. Patients can be included if they are at least 18 years, presenting with a witnessed cardiac arrest of presumed cardiac origin, and if either basic life support had started within 10 min of onset and had been performed up to 10 min or advanced life support is started within 10 min of onset of cardiac arrest. Primary endpoint of the study is the 30-day survival rate, and the coprimary endpoint is hospital admission. Secondary endpoints are the return of spontaneous circulation (ROSC), survival after 24 h, survival to hospital discharge, and neurological performance. Safety endpoints include major bleeding complications and symptomatic intracranial haemorrhage.

Naftidrofuryl can enhance the quality of life in patients with intermittent claudication.

BACKGROUND: Using a disease specific questionnaire, the CLAU-S, we undertook a double blind, placebo controlled study in patients with intermittent claudication to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients' quality of life. PATIENTS AND METHODS: 287 patients, with stable intermittent claudication for at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients know to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared with respect to difference between the initial and final values. RESULTS: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions "daily living", "pain", "disease specific anxiety" and "mood". A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p = 0.004). CONCLUSIONS: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with intermittent claudication.

Trisomy 14: a new entity within acute nonlymphocytic leukemia.

Three cases of acute nonlymphocytic leukemia with trisomy 14 as the sole chromosome abnormality are presented and it is suggested that this type of trisomy, either as an extra chromosome or an isochromosome, is phenotypically equivalent. The findings are presented in relation to other cases previously reported.

Therapy of acute myelocytic leukemia. Daunomycin contrasted with a combination of cytosine arabinoside and 6-thioguanine.

Twenty-three patients with acute myelocytic leukemia (aml) were treated with daunomycin and the results contrasted to those obtained in a subsequent group of 18 patients treated with cytosine arabinoside (ara-c) and 6-thioguanine (tg). The complete remission (cr) rate with daunomycin was 17 percent (mean duration 10.6 months) and the partial remission (pr) rate 26 percent (mean duration 44 days). Corresponding figures in the ara-c and tg group were: cr rate 44 percent (mean duration 5.8 months) and pr rate 17 percent (mean duration 48 days). There were 12 deaths resulting from daunomycin-induced pancytopenia and in ten of the patients who died persistent leukemia infiltrate was found in antemortem marrow specimens or at autopsy. This contrasts with death of six patients from ara-c and tg-induced pancytopenia, in four of whom residual leukemic infiltrate was not evident. Daunomycin alone is deemed not suitable for induction of remission in aml. The results obtained with ara-c and tg are encouraging and may be improved if the number of infectious deaths associated with drug-induced pancytopenia can be reduced.