Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study.

BACKGROUND AND OBJECTIVES: C.E.R.A., a continuous erythropoietin receptor activator, offers once-monthly dosing without compromising haemoglobin control. This study was undertaken to examine whether monthly C.E.R.A. using pre-filled syringes maintains stable haemoglobin levels when administered according to local clinical judgement. RESEARCH, DESIGN AND METHODS: MIRACEL was a prospective, open-label, single-arm, multicentre study performed at 90 nephrology centres in Germany. After a 2-month screening phase, haemodialysis patients receiving epoetin or darbepoetin were converted to monthly intravenous C.E.R.A., with a 5-month titration phase followed by a 2-month evaluation phase. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT00413894 RESULTS: Of 661 patients screened, 424 (64.1%) started C.E.R.A. therapy (previous treatment: 72.2% epoetin, 27.8% darbepoetin); 416 were eligible for inclusion in the intent-to-treat population. A mean of two C.E.R.A. dose changes were required during the 7-month treatment period. The primary efficacy variable, haemoglobin within 11-12.5 g/dL or 10-13 g/dL during the evaluation phase, was achieved in 109 (30.8%) and 265 (74.9%) of the 354 evaluable patients, respectively, with no differences observed between patients formerly receiving epoetin or darbepoetin or different dosing frequencies. During the screening, titration and evaluation phases, mean haemoglobin was 11.7 +/- 0.7 g/dL, 11.6 +/- 0.9 g/dL and 11.4 +/- 1.0 g/dL, respectively, and 90.6% (377/416), 70.4% (293/416) and 82.9% (345/416) of patients exhibited < or = 1 g/dL change from phase-specific individual means. C.E.R.A. was well-tolerated with a safety profile similar to that reported in phase III studies. CONCLUSIONS: In this single-arm, open-label, multicentre study, conversion of a large population of haemodialysis patients from epoetin or darbepoetin to monthly C.E.R.A. administration using pre-filled syringes was shown to be practical, convenient and offer good control of haemoglobin levels, regardless of the previous type of therapy or dosing frequency.

Atomic force microscopy study of immunosensor surface to scale down the size of ELISA-type sensors.

Here we describe the use of atomic force microscopy (AFM) to study the nanoscale mechanics of the molecular layers of a popular immunosensor, ELISA (enzyme-linked immunosorbent assay) type. We characterize the sensor surface in terms of brush length and grafting density of the molecular layers. The obtained data demonstrated that a reliable reading of the immunosignal (a suggested dimensionless combination of brush length and grafting density) can be attained from an area as small as approximately 3 microm(2). This is approximately 4 million times smaller compared to typical ELISA sensors. The immunosensor described is composed of a molecular mix of two different antigens. Intriguingly, we find that AFM can reliably distinguish between having the immunosignal from either antibody and from both antibodies together. This was impossible to get by using standard optical detection methods.

A review of 300 attempted strangulation cases. Part I: criminal legal issues.

Three hundred strangulation cases, submitted for misdemeanor prosecution to the San Diego City Attorney's Office, were evaluated to determine the signs and symptoms of attempted strangulation that could be used to corroborate the victim's allegation of being "choked" for purposes of prosecution. The study reveals that a lack of training may have caused police and prosecutors to overlook symptoms of strangulation or to rely too heavily on the visible signs of strangulation. Because most victims of strangulation had no visible injuries or their injuries were too minor to photograph, opportunities for higher level criminal prosecution were missed.

A review of 300 attempted strangulation cases Part II: clinical evaluation of the surviving victim.

Medical literature describing victims who survive strangulation is scant. The majority of articles on strangulation are found in the forensic literature, describing the post-mortem findings on autopsy. This article presents a suggested protocol for the evaluation and treatment of the surviving victim of strangulation, based upon a review of the available literature. It also corroborates the findings of Strack et al., in the study by the San Diego City Attorney's Office, described in Part I of this series.

A review of 300 attempted strangulation cases Part III: injuries in fatal cases.

A review of 300 cases of alleged strangulation assault, submitted for misdemeanor prosecution by the San Diego City Attorney's Office, led to a search for medical evidence that would be useful to prosecute these cases (see Strack et al. in this issue of the Journal). The injuries identified in these non-fatal cases are similar to injuries found in fatal domestic violence strangulation assaults. This article reviews the injuries recognizable at autopsy in cases of strangulation in domestic violence victims.

The Demers atrial catheter: experience with a single-lumen silicone catheter as short- and long-term access for hemodialysis.

The Demers catheter is a silicone atrial catheter with a dacron cuff used as short- and long-term access for hemodialysis. It was implanted in 316 patients between January 1, 1987 through May 31, 1991. Data on these implantations were retrospectively analyzed and are reported here. Follow-up and analysis was possible in 404 of 417 Demers catheter implantations. The mean age of patients in this study was 61 years. For short-term use (< 91 days) 153 catheters were implanted in 135 patients, for long-term use (> 90 days) 251 catheters in 181 patients. The median life span of all 404 catheters was 87 days. The median life span for long-term use was 150 days (2-1302) per catheter and 220 days (92-1717) per patient. Catheter malfunction (arterial blood flow < 200 ml) was encountered every 876 days in the running time of the catheter. Twenty percent (n = 80) of the catheters were explanted because of complications. These included 42 cases of catheter malfunction and 22 cases of infection.