Measuring rFIX-Fc with 17 Different Combinations Coagulometers — Reagents: A Single Center Study

Abstract rFIX-Fc is an extended half-life (EHL) recombinant FIX concentrate approved for the prophylaxis and treatment of bleeding events in haemophilia B. A high laboratory and reagent-specific variability is described for rFIX-Fc activity measurements, overall in lower FIX concentrations. The aim of this single-center study was to evaluate the intra-laboratory variability of 17 different combinations coagulometers/reagents including both one stage clotting (OSC) and chromogenic assays with a focus on lower concentrations. Human FIX deficient plasma (FIX<1%, George King Bio-Medical) was spiked with rFIX-Fc at 150%, 100%, 80%, 20%, 5%, 2% and 1% based on label potency. We evaluated the spikes recovery with 3 coagulometers (STAR MAX (Stago), ACL TOP700 (Werfen) and Cs2100 (Siemens)) using for each instrument captive silica based aPTT reagents (PTT automate (Stago) and Pathromtin (Siemens)) and non-silica based (CK Prest (Stago), Synthafax (Werfen) and Actin FS (Siemens)). Two reagents (STA-Cephascreen (Stago) and Synthafax (Werfen)) were evaluated on all coagulometers because they potentially behave one the same way for EHL FIX products. The 2 available chromogenic assays (ROS FIXa (Rossix) and Biophen FIX:C were evaluated on all coagulometer. All experiments were performed by the same staff, in a single room, in triplicates with 3 dilutions. For a given combination, all the concentrations were evaluated on the same calibration curve. The spike recovery were calculated as the (mean of 3 experiments / targeted FIX value) x 100. The range values of 70% - 130% were considered as acceptable for spike recoveries'. The summary of all spikes recoveries' are presented in table 1. We confirmed that kaolin based OSC assays underestimate rFIX-Fc including for low concentrations. Acceptable recoveries were found for PTT automate on Stago coagulometer from 150% to 5% and an underestimation was found for low concentrations (2% and 1 %). Pathromtin and Actin FS performed on Cs2100 display acceptable recoveries on all the range of target values. Synthasil performed on ACL TOP700 have acceptable recoveries from 150% to 20% and an overestimation was found for low concentrations (5% to 1%). STA-Cephascreen performed on the 3 coagulometers has acceptable recoveries, except for low concentrations (5% to 1%) on ACL TOP coagulometer, leading to an overestimation of rFIX-FC measurements. Synthafax performed on the 3 coagulometers has acceptable recoveries with ACL TOP700 coagulometer for all the range of concentrations. This reagent adapted on STAR MAX coagulometer shows an overall overestimation of rFIX-Fc measurements (except for the 150% target concentration) and when adapted on a Cs2100 coagulometer, it displays acceptable recoveries except for low concentrations (5% to 1%) that are overestimated. The two chromogenic assays have acceptable recoveries for rFIX-Fc on all coagulometers from 150% to 50% concentrations. ROS FIXa underestimated rFIX-Fc recovery for the lower concentrations (1% and 2%) on STAR MAX and ACL TOP700 coagulometers. Biophen FIX:C underestimated rFIX-Fc recoveries for concentrations below 50% with all coagulometers. This study provides the pattern of several combinations coagulometers - reagents for rFIX-Fc measurements and confirms a high variability for several reagents for low concentrations. Table. Table. Disclosures Lebreton: Sobi: Consultancy, Research Funding.

Download Full-text

The effects of full weight-bearing mobilization on clinical outcomes and subsidence in cemented and uncemented hemiarthroplasty in osteoporotic patients: A retrospective single-center study

Journal of Back and Musculoskeletal Rehabilitation ◽

10.3233/bmr-210024 ◽

2021 ◽

pp. 1-8

Author(s):

Betül Başar ◽

Hakan Başar

Keyword(s):

Clinical Outcomes ◽

Weight Bearing ◽

Femoral Stem ◽

Harris Hip Score ◽

Full Weight Bearing ◽

Single Center ◽

Single Center Study ◽

Uncemented Hemiarthroplasty ◽

The Mean ◽

Center Study

BACKGROUND: Early full weight-bearing mobilization is controversial in osteoporotic patients who have undergone uncemented hemiarthroplasty (CH). OBJECTIVES: The aim of the study was to compare the results of early full weight-bearing mobilization in CH and uncemented hemiarthroplasty (UCH). The effect of subsidence on the results was also evaluated. METHODS: Fifty-nine patients who underwent CH and UCH were evaluated. The mean age was 79.8 years (10 females, 15 males) for CH and 75.5 years (10 females, 24 males) for UCH. All patients started immediate full weight-bearing mobilization and weight-bearing exercises. RESULTS: There was no difference between the groups according to the Harris Hip Score. Both groups were evaluated in subgroups according to whether there is varus in the femoral stem. There was no difference between subgroups according to the Harris Hip Score. The femoral subsidence was not determined in CH group. In the UCH group, the subsidence was 1.13 ± 1.03 mm in varus femoral stem subgroup and 0.81 ± 0.85 mm in without femoral stem varus subgroup. There was no difference in subsidence between femoral stem with varus and without varus. The subsidence did not affect the Harris Hip Score. CONCLUSION: Full weight-bearing mobilization could be safely preferred in UCH, as in CH. Femoral stem varus below 5 degrees does not affect the results and subsidence.

Download Full-text

Post-Transplant Erythrocytosis in Live Donor Kidney Transplant Recipients: A Retrospective Single Center Study

Journal of Institute of Medicine ◽

10.3126/jiom.v42i3.37585 ◽

2020 ◽

Vol 42 (3) ◽

pp. 62-66

Author(s):

Suresh Maharjan ◽

Santosh Chhetri ◽

Bikash Khatri ◽

Nisha Sapkota ◽

Mahesh R Sigdel

Keyword(s):

Kidney Transplant ◽

Transplant Recipients ◽

Single Center ◽

Kidney Transplant Recipients ◽

Donor Kidney ◽

Live Donor Kidney ◽

Single Center Study ◽

The Mean ◽

Mean Time ◽

Center Study

Introduction Post-transplant erythrocytosis (PTE) is defined as persistently elevated hemoglobin>17 g/dl and/or PCV>51% in kidney transplant recipients. The incidence of PTE varies from 5% to 17%, with occasional life‑threatening thromboembolic complications. We aimed to study the prevalence, risk factors and complications of PTE. MethodsWe conducted a retrospective single center study in 132 kidney transplant recipients who had undergone live donor kidney transplantation at Tribhuvan University Teaching Hospital, Nepal, between October 2017 and March 2019. Prior approval was obtained from Institutional Review Committee of Institute of Medicine. Patients with hemoglobin>17 g/dl were defined as PTE group, and others as non‑PTE group. The pattern of hemoglobin, serum creatinine, pre-transplant hemoglobin, native kidney disease, immunosuppression medications, rejection episodes, and new onset diabetes after transplantation were analyzed and compared between two groups. ResultsOut of the 132 kidney transplant recipients, PTE was diagnosed in 28 (21.2%) patients, out of which 27 patients (96.4%) were male and 1 (3.6%) were female with the mean time of onset at 7 months after transplantation. Patients with erythrocytosis had a relatively shorter duration of pre transplant dialysis (p=0.001). The mean pre transplant Hb and Hct in PTE group was 9.72g/dl and 30.35% whereas in non PTE group 10.02 g/dl and 31.31%. Thromboembolic and any other PTE related complications were not observed. Seventeen patients of PTE (60.7%) were treated with ACE Inhibitors and 11 (39.9%) patients did not require any treatment. ConclusionPost-transplant erythrocytosis was seen in nearly one fifth kidney transplant recipients at mean time of seven months post-transplantation; was more common in male with good graft function, and short duration of pre transplant dialysis. Response to ACE inhibitors was good.

Download Full-text

Consequences of COVID-19 pandemic lockdown on emergency and stroke care in a German tertiary stroke center

Neurological Research and Practice ◽

10.1186/s42466-021-00118-z ◽

2021 ◽

Vol 3 (1) ◽

Author(s):

Robin Jansen ◽

John-Ih Lee ◽

Bernd Turowski ◽

Marius Kaschner ◽

Julian Caspers ◽

...

Keyword(s):

Stroke Unit ◽

Hot Spot ◽

Stroke Care ◽

Single Center ◽

Stroke Patients ◽

Number Of Patients ◽

Single Center Study ◽

The Mean ◽

Stroke Center ◽

Center Study

Abstract Background COVID-19 pandemic caused a decline in stroke care in several countries. The objective was to describe lockdown stroke care in a tertiary stroke center in Düsseldorf, Germany near Heinsberg, a German hot spot for COVID-19 in spring 2020. Methods In a retrospective, observational, single-center study, we compared all patients treated in our emergency department (ED), patients seen by a neurologist in the ED, ED patients suffering from ischemic and hemorrhagic strokes and transient ischemic attacks (TIAs) as well as stroke patients admitted to our stroke unit during lockdown in spring 2020 (16 March 2020–12 April 2020) to those cared for during the same period in 2019 and lockdown light in fall 2020 (2 November – 29 November 2020). Results In spring 2020 lockdown the mean number of patients admitted to our ED dropped by 37.4%, seen by a neurologist by 35.6%, ED stroke patients by 19.2% and number of patients admitted to our stroke unit by 10% compared to the same period in 2019. In fall lockdown light 2020 effects were comparable but less pronounced. Thrombolysis rate was stable during spring and fall lockdown, however, endovascular treatment (EVT) rate declined by 58% in spring lockdown and by 51% in fall lockdown compared to the period in 2019. Conclusions Our study indicates a profound reduction of overall ED patients, neurological ED patients and EVT during COVID-19 pandemic caused lockdowns. Planning for pandemic scenarios should include access to effective emergency therapies.

Download Full-text

The effect of montelukast in children with asthma predictive ındex negative episodic viral wheezing

10.22541/au.162447435.59785703/v1 ◽

2021 ◽

Author(s):

Ayşe Aydoğdu ◽

Cihan Fidan

Keyword(s):

Median Number ◽

Potential Treatment ◽

Single Center ◽

Predictive Index ◽

Pediatric Allergy ◽

Allergy And Immunology ◽

Single Center Study ◽

Children With Asthma ◽

The Mean ◽

Center Study

Background: The effectiveness of montelukast for wheezing in young children is not clear. We aimed to evaluate whether the use of montelukast in the treatment of wheezing affects the number of attacks in children aged 1 to 6 years. Methods: This is a single center study. It was conducted between August 2019 – 2020. Children with aged 0-6 years old with a wheezing complaint who applied to the pediatric allergy and immunology outpatient clinic were included in the study. Modified asthma predictive index of the patients were evaluated. It was classified as episodic viral wheezing (EVW) or multiple trigger wheezing (MTW) based on the type of wheezing. Montelukast treatment was started and the number of attacks was checked. Results: The total of 141 children who applied with wheezing complaints were included in the study. The majority of the patients were boys (n=99). The mean age of the children was 4.2 ± 1.5 years. The median number of attacks before treatment was 2 (2-3). In 2.8% of the patients, eczema, in 12.8% of them, rhinitis and in 26.7% of them, elevated eosinophils were detected. IgE levels were 148.25 ± 279.20 IU/mL. According to the number of attacks before treatment, there was a significant decrease in the number of attacks in the control (p <0.001). Conclusion: In this study, montelukast has been shown to reduce the number of EVW attacks and we believe montelukast may be a potential treatment option for EVW in preschool children.

Download Full-text

Extravasation of iodinated contrast medium in cancer patients undergoing computed tomography

Radiologia Brasileira ◽

10.1590/0100-3984.2017.0064 ◽

2018 ◽

Vol 51 (4) ◽

pp. 236-241 ◽

Cited By ~ 1

Author(s):

Hernandes Cerqueira de Souza Silva ◽

Almir Galvão Vieira Bitencourt ◽

Rubens Chojniak

Keyword(s):

Computed Tomography ◽

Contrast Medium ◽

Cancer Patients ◽

Cancer Center ◽

Single Center ◽

Iodinated Contrast Medium ◽

Iodinated Contrast ◽

Single Center Study ◽

The Mean ◽

Center Study

Abstract Objective: The aim of this study was to evaluate the incidence of extravasation of iodinated contrast medium (ICM) at the site of intravenous injection in oncology patients submitted to computed tomography (CT). Materials and Methods: This was a retrospective, descriptive, single-center study that evaluated all patients who underwent CT with ICM administration and presented ICM extravasation, at a cancer center, between January 2010 and December 2015. Results: During the study period, we evaluated a total of 99,076 ICM injections and identified 199 cases of extravasation, the incidence rate therefore being 0.20%. Among the patients who presented extravasation, the mean age was 59.22 years and 60% were female. The extravasation was classified as mild in 94.10% of the patients and as moderate in 5.90%. There were no cases of severe extravasation in the sample. Conclusion: The incidence of ICM extravasation in cancer patients submitted to CT in the present study was similar to that reported for the general population, according to other studies in the literature. The vast majority of cases of extravasation were considered mild, and no severe cases were observed in the study sample.

Download Full-text

Clinical Features and Genetic Analysis of 48 Patients with Chronic Granulomatous Disease in a Single Center Study from Shanghai, China (2005–2015): New Studies and a Literature Review

Journal of Immunology Research ◽

10.1155/2017/8745254 ◽

2017 ◽

Vol 2017 ◽

pp. 1-17 ◽

Cited By ~ 12

Author(s):

Jing Wu ◽

Wei-Fan Wang ◽

Yi-Dan Zhang ◽

Tong-Xin Chen

Keyword(s):

Chronic Granulomatous Disease ◽

Mainland China ◽

Gene Mutations ◽

Autosomal Recessive Inheritance ◽

Granulomatous Disease ◽

Single Center ◽

Phagocyte Nadph Oxidase ◽

Single Center Study ◽

The Mean ◽

Center Study

Chronic Granulomatous Disease (CGD) is a rare inherited primary immunodeficiency, which is characterized by recurrent infections due to defective phagocyte NADPH oxidase enzyme. Nowadays, little is known about Chinese CGD patients. Here we report 48 CGD patients in our single center study, which is the largest cohort study from Mainland China. The ratio of male to female was 11 : 1. The mean onset age was 0.29 years old, and 52% patients had an onset within the 1st month of life. The mean diagnosis age was 2.24 years old. 11 patients (23%) had died with an average age of 2.91 years old. 13 patients (28%) had positive family histories. The most prevalent infectious sites were the lungs (77%), followed by gastrointestinal tract (54%), lymph nodes (50%), and skin (46%). In addition, septicopyemia, thrush, and hepatosplenomegaly were also commonly observed, accounting for 23%, 23%, and 40% of the cases. Lesions due to BCG vaccination occurred in more than half of the patients. X-linked CGD due to CYBB gene mutations accounted for 75% of the cases, and 11 of them were novel mutations. Autosomal recessive inheritance accounted for 6% patients, including 1 patient with CYBA, 1 with NCF1, and 1 with NCF2 gene mutations.

Download Full-text