Introduction: Intracerebral hemhaemorrhage (ICH) is the deadliest form of stroke. HemHaematoma expansion (HE), growth of the hemhaematoma between the baseline computed tomography (CT) scan and a follow-up CT scan at 24±6 hours, predicts long-term disability or death. Recombinant Factor VIIa (rFVIIa) has reduced HE in previous clinical trials with a variable effect on clinical outcomes, with the greatest impact on HE and potential benefit when administered within two hours of symptom onset. Methods: Factor VIIa for HemHaemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST, NCT03496883) is a randomized controlled trial that will enroll 860 patients at ~100 emergency departments and mobile stroke units in five countries. Patients are eligible for enrollment if they have acute ICH within two hours of symptom onset confirmed by CT, a hemhaematoma volume of 2 to 60 mL, no or small volumes of intraventricular hemhaemorrhage, do not take anticoagulant medications or concurrent heparin/heparinoids (antiplatelet medications are permissible), and are not deeply comatose. Enrolled patients will receive rFVIIa 80 mcg/kg or placebo intravenously over 2 minutes. The primary outcome measure is the distribution of the ordinal modified Rankin Scale at 180 days. FASTEST is monitored by a Data Safety Monitoring Board. Safety endpoints include thrombotic events (e.g., myocardial infarction). Human subjects research is monitored by an external Institutional Review Board in participating countries. Discussion: In the US, FASTEST will be first NIH StrokeNet Trial with an Exception from Informed Consent which allows enrollment of non-communicative patients without an immediately identifiable proxy.
Objective
To investigate the relationship between abdominal ultrasound (US) findings and demographic, historical and clinical features in children with CF.
Study design
Children age 3-12 years with CF without known cirrhosis, were enrolled in a prospective, multi-center study of US to predict hepatic fibrosis. Consensus US patterns were assigned by 3 radiologists as normal, heterogeneous, homogeneous, or cirrhosis. Data were derived from direct collection and U.S. or Toronto CF registries. Chi-square or ANOVA were used to compare variables among US groups and between normal and abnormal. Logistic regression was used to study risk factors for having abnormal US.
Results
Findings in 719 subjects were normal (n=590, 82.1%), heterogeneous (64, 8.9%), homogeneous (41, 5.7%), and cirrhosis (24, 3.3%). Cirrhosis (p=0.0004), homogeneous (p<0.0001) and heterogeneous (p=0.03) were older than normal. More males were heterogeneous (p=0.001). More heterogeneous (15.0%, p=0.009) and cirrhosis (25.0%, p=0.005) had CF-related diabetes or impaired glucose tolerance versus normal (5.4%). Early infection with Pseudomonas aeruginosa (<2 years old) was associated with a lower risk (OR 0.42, p=0.0007) of abnormal. Ursodeoxycholic acid use (OR 3.69, p <0.0001) and CF-related diabetes (OR 2.21, p=0.019) were associated with increased risk of abnormal.
Conclusions
Unsuspected cirrhosis is seen in 3.3% of young patients with CF, heterogeneous in 8.9%. abnormal US is associated with CF-related diabetes, and early P aeruginosa is associated with normal US. Prospective assessment of these risk factors may identify potential interventional targets.
In anaesthetized patients, administration of citrated whole blood for 5 min at controlled rates of 50, 100 and 150 ml/70 kg/min resulted in decreases in the calcium ion concentration (Ca2+) of 14, 31 and 41%, respectively. Ca2+ returned rapidly to the control values after termination of the transfusion. Reciprocal changes in serum citrate concentrations occurred, suggesting that the transient hypocalcaemia was a result of redistribution of citrate and hepatic or renal clearance from the vascular space. The total serum calcium concentration did not change significantly during rapid blood administration. Normal saline infusion at 100 ml/70 kg/min caused no change in Ca2+; however, plasma protein administration at this rate resulted in an 18% decrease in Ca2+, presumably as a consequence of the binding of calcium ions to anionic sites on plasma protein. Hypocalcaemia accompanying blood transfusion is a transient phenomenon, dependent on the total dose of citrate administered and the rate of infusion. Rational calcium replacement therapy during massive blood transfusion may now be based on direct Ca+ measurement.
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