Clinical events following cerebral angiography were prospectively evaluated in 1,002 procedures. The ischemic event rate between 0 and 24 hours was 1.3% (0.1% permanent). This incidence was higher (2.5%) in patients investigated for cerebrovascular disease, but the difference was not significant. In addition, 1.8% of the patients suffered ischemia (0.3% permanent) between 24 and 72 hours after angiography. Cerebral ischemic events occurred as a recurrence or worsening of a preexisting condition twice as often as de novo. All permanent ischemia was a worsening of a preexisting phenomenon. There was a significant increase in the incidence of neurologic events between 0 and 24 hours when the procedure lasted longer than 60 minutes and when there was systolic hypertension. Trends toward higher incidence were noted with the use of increased volume of contrast, with increased serum creatinine, when transient ischemic attacks or stroke were the indications, and when 3 or more catheters were used. The incidence of neurologic events between 24 and 72 hours increased significantly with the increase in the amount of contrast used, with age, and with diabetes. The occurrence of nonneurologic events (mostly hematomas) was significantly increased by multiple factors. This study shows that events can and do occur beyond the usual observation period of 24 hours but confirms the low risk of cerebral angiography when performed judiciously. (Stroke 1987;18:997-1004)

One course of intravenous immunoglobulins (IVIg) of 2 g/kg is standard treatment in Guillain-Barré syndrome (GBS) patients unable to walk independently. Despite treatment some patients recover poorly, in part related to rapid consumption of IVIg, indicating that they may benefit from a second course of IVIg. The aim of the study is to determine whether a second course of IVIg, administered 1 week after start of the first course in patients with GBS and predicted poor outcome improves functional outcome on the GBS disability scale after 4 weeks. Secondary outcome measures include adverse events (AEs), Medical Research Council sumscore and GBS disability score after 8, 12, and 26 weeks, length of hospital and ICU admission, mortality, and changes in serum IgG levels. GBS patients of 12 years and older with a poor prognosis, based on the modified Erasmus GBS outcome score (mEGOS) at 1 week after start of the first IVIg course are eligible for randomization in this double-blind, placebo-controlled (IVIg or albumin) clinical trial. This study will determine if a second course of IVIg administered in the acute phase of the disease is safe, feasible, and effective in patients with GBS and a poor prognosis. This Dutch trial is registered prospectively as NTR 2224 in the Netherlands National Trial Register (NTR) which is the Primary Registry in the WHO Registry Network for the Netherlands.

Second intravenous immunoglobulin dose in patients with Guillain-Barre syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial. Lancet Neurology, 20(4), 275-283.

No abstract

5071 Background: The alpha emitter radium-223 is a bone-seeking radionuclide studied as a novel treatment for patients with HRPC and bone metastases. Ra-223 showed minimal toxicity in a phase 1 study (Nilsson S, et al., Clin Cancer Res 2005;11 (12): 4451–59). Here we present outcome data from a randomised phase II study. Methods: Patients with HRPC and bone pain requiring external beam radiotherapy were randomized to treatment with 4 injections of either Ra-223 (50 kBq/kg b.w.) or saline (placebo) every 4 weeks. The primary endpoints were change in bone-alkaline phosphatase (ALP) levels from baseline to 4 weeks after last injection (previously reported (Bruland ØS, et al. Clin Cancer Res 2006;12:6250s-57s), and time to occurrence of Skeletal Related Events (SREs). Secondary endpoints included toxicity, PSA progression and overall survival. Results: 33 patients were randomised to Ra-223 and 31 to placebo. The two groups were well balanced with respect to standard prognostic factors. Mild, transient haematological toxicity was seen after Ra-223. Long term toxicity was not observed. SAEs were observed in 8 patients in the Ra-223 group versus 14 in the placebo group. Based on intention to treat analysis, the median time to PSA progression was 26 versus 8 weeks (p=0.047) for Ra-223 versus placebo, respectively. The median time to first SRE was 28 versus 26 weeks (p= 0.164). The median overall survival was 65.3 weeks versus 46.4 weeks (p = 0.066). The hazard ratio for overall survival, adjusted for baseline PSA, albumin, LDH and performance status was 2.11 (95 % CI: 1.08 - 4.13, p=0.029). At 18 months, 15 (45%) versus 8 (26%) patients patients were still alive. Conclusions: Alpharadin was extremely well tolerated, with minimal myelotoxicity, and with encouraging evidence of efficacy. Larger clinical trials are warranted to study the impact of Alpharadin on the prevention of SREs and on overall survival in HRPC. The bone targeting properties of Alpharadin, may also be applicable to the treatment of skeletal metastasis from other primary cancers. [Table: see text]