Programmes for the management of preoperative anaemia: audit in ten European hospitals within the PaBloE (Patient Blood Management in Europe) Working Group.

Background And Objectives: Preoperative anaemia is an independent risk factor for a higher morbidity and mortality, a longer hospitalization and increased perioperative transfusion rates. Managing preoperative anaemia is the first of three pillars of Patient Blood Management (PBM), a multidisciplinary concept to improve patient safety. While various studies provide medical information on (successful) anaemia treatment pathways, knowledge of organizational details of diagnosis and management of preoperative anaemia across Europe is scarce.

The systematic use of evidence-based methodologies and technologies enhances shared decision-making in the 2018 International Consensus Conference on Patient Blood Management.

Background And Objectives: Patient Blood Management (PBM) aims to optimize the care of patients who might need a blood transfusion. The International Consensus Conference on PBM (ICC-PBM) aimed to develop evidence-based recommendations on three topics: preoperative anaemia, red blood cell transfusion thresholds and implementation of PBM programmes. This paper reports how evidence-based methodologies and technologies were used to enhance shared decision-making in formulating recommendations during the ICC-PBM.

Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference.

Importance: Blood transfusion is one of the most frequently used therapies worldwide and is associated with benefits, risks, and costs.

Objective: To develop a set of evidence-based recommendations for patient blood management (PBM) and for research.

Evidence Review: The scientific committee developed 17 Population/Intervention/Comparison/Outcome (PICO) questions for red blood cell (RBC) transfusion in adult patients in 3 areas: preoperative anemia (3 questions), RBC transfusion thresholds (11 questions), and implementation of PBM programs (3 questions).

Patient blood management knowledge and practice among clinicians from seven European university hospitals: a multicentre survey.

Background And Objectives: The aim of this survey was to evaluate the knowledge about Patient Blood Management (PBM) principles and practices amongst clinicians working in seven European hospitals participating in a European Blood Alliance (EBA) project.

Materials And Methods: A web-based questionnaire was sent to 4952 clinicians working in medical, surgery and anaesthesiology disciplines. The responses were analysed, and the overall results as well as a comparison between hospitals are presented.

The revision of the European blood directives: A major challenge for transfusion medicine.

Aim: Using both patient-focused and donor-focused perspectives, to review the current EU blood directives, in order to derive proposals, in principle, for what should evolve during the revision process of these directives.

Methods: Review of the EU blood directives in the light of scientific literature, related reports from the Directorate General Health and Consumers (DG SANTÉ), and from the Council of Europe (CoE).

Results: The analyses led us to present the main following proposals: developing voluntary unpaid donations: the directives should consider taking into consideration ethically acceptable forms of compensation consistent with altruistic donation (including plasma donations for fractionation); current expertise: more extensive utilization of the expertise of blood establishments and their consultants should be considered; donor selection: an evidence-based approach for basing donor deferral criteria on sound scientific evidence should be promoted; donor reactions: measures to prevent donor reactions and to make donations safer for the donors should also be included; quality control: The quality control requirements should relate to the Council of Europe Blood Guide specifications: these should become minimum standards (as is the case with monographs of the European Pharmacopeia), facilitating regular update of blood component lists and related specifications and compliance with the specifications; haemovigilance: because of reporting difficulties (e.

Collection, processing and testing of bone, corneas, umbilical cord blood and haematopoietic stem cells by European Blood Alliance members.

Background And Objectives: A questionnaire study was carried out in collaboration with the European Blood Alliance (EBA) Tissues and Cells (T&C) working group. The aim was to assess the level of involvement and commonality of processes on the procurement, testing and storage of bone, corneas, umbilical cord blood (UCB) and haematopoietic stem cells (HSC) in order to identify different practices and to explore whether recommendations can be made for harmonization.

Materials And Methods: An online questionnaire was used for data collection in 2011, and 43 replies were received covering 71 product answers from 13 countries.

Growth of erythroid cells from thawed unseparated cord blood in vitro without exogenous erythropoietin.

Introduction: Previous erythroid cell cultures have depended on added serum or erythropoietin. In this paper, the growth of erythroid cells from thawed unseparated cord blood units in vitro without serum or exogenous erythropoietin is reported.

Methods: Thawed volume-reduced cord blood was cultured in conditions designed to support the megakaryocytic lineage, with thrombopoietin and interleukins 3 and 6.

Association of CFU-Mk with total colony-forming units in thawed cord blood units.

Background And Objectives: Cord blood unit (CBU) total colony-forming unit (CFU) count both pre-cryo and post-thaw has been shown to be associated with platelet (PLT) engraftment. Pre-cryo CBUs show good growth of megakaryocytic CFUs (CFU-Mk); however, CFU-Mk have rarely been studied in post-thaw CBUs.

Materials And Methods: Nucleated cells (NCs) from post-thaw CB were cultured in a collagen-based assay designed to support growth of CFU-Mk.

Association between the ABO blood group and the human intestinal microbiota composition.

Background: The mucus layer covering the human intestinal epithelium forms a dynamic surface for host-microbial interactions. In addition to the environmental factors affecting the intestinal equilibrium, such as diet, it is well established that the microbiota composition is individually driven, but the host factors determining the composition have remained unresolved.

Results: In this study, we show that ABO blood group is involved in differences in relative proportion and overall profiles of intestinal microbiota.

Secretor genotype (FUT2 gene) is strongly associated with the composition of Bifidobacteria in the human intestine.

Intestinal microbiota plays an important role in human health, and its composition is determined by several factors, such as diet and host genotype. However, thus far it has remained unknown which host genes are determinants for the microbiota composition. We studied the diversity and abundance of dominant bacteria and bifidobacteria from the faecal samples of 71 healthy individuals.

Association of cord blood platelet count and volume with hemoglobin in healthy term infants.

Objective: The aim of this study was to investigate relationships of cord blood cells in healthy term infants both from vaginal and Cesarean sections.

Study Design: The study sample comprised 167 consecutive cord blood collections accepted for processing in an accredited cord blood bank. The effect of varying anticoagulant-to-blood ratio was excluded by standardizing the cell concentrations to reflect the values in native blood.

Prothrombin activation fragment 1 + 2 as a marker of coagulation activation in cord blood collection for banking.

There have been efforts to increase the quality of cord blood (CB) collections aimed at banking and transplantation. Yet, the effect of CB collection techniques on haemostatic activation is scarcely studied, despite the unique nature of the neonatal haemostatic system. The aim of this study was to explore coagulation system and platelet (PLT) activation during CB collection at a national CB bank.

Association of stress-related perinatal factors and cord blood unit hematopoietic progenitors is dependent on delivery mode.

Background: Perinatal characteristics, variably utilized in cord blood (CB) selection for banking, affect CB hematopoietic progenitor cells (HPCs). The association between perinatal stress factors and CB unit HPCs was evaluated.

Study Design And Methods: Umbilical arterial (UA) pH, absolute and relative birth weight (BW) and placental weight (PW), and PW/BW ratio of 167 healthy, full-term infants were compared with CB unit prefreeze total nucleated cells (TNCs), total CD34+ (TCD34+) cells, and total colony-forming unit (CFU-TOT) number.

Mitochondrial function determines the viability and osteogenic potency of human mesenchymal stem cells.

Advanced therapies medicinal products (ATMPs) have introduced innovative cell-based products. However, the regulatory demands for characterization of ATMPs are currently unable to adequately address the safety of such products. As recent studies have emphasized the role of mitochondria in the osteogenic differentiation of human mesenchymal stem cells (hMSCs), we have studied in detail the viability and osteogenic differentiation potency of the hMSCs intended for use as ATMPs based on analyses of the mitochondrial inner membrane potential (DeltaPsi(m)).

Pharmacokinetic-pharmacodynamic relationship of dobutamine and heart rate, stroke volume and cardiac output in healthy volunteers.

Background And Objective: Dobutamine causes an increase in cardiac output (CO) by augmenting stroke volume (SV) through enhanced left ventricular contractility and by decreasing systemic vascular resistance. However, in some patients, the dominant mechanism by which dobutamine improves left ventricular performance is an increase in the subject's heart rate (HR). We therefore decided to evaluate the pharmacokinetic-pharmacodynamic relationship of dobutamine plasma concentrations and heart rate, SV and CO in healthy volunteers.

Effect of time interval between food and drug ingestion on the absorption of oxybutynin from a controlled-release tablet.

The effect of time interval between food and drug ingestion on the bioavailability of oxybutynin was investigated in a randomized, three-phase cross-over study in 31 healthy volunteers. The serum concentrations of oxybutynin and the metabolite, N-desethyloxybutynin were measured up to 48 hr after ingestion of a controlled-release 10 mg oxybutynin tablet either in fasting state, 2 hr after breakfast or 1 hr before. The Cmax of both oxybutynin (P < 0.

Itraconazole moderately increases serum concentrations of oxybutynin but does not affect those of the active metabolite.

Objective: Oxybutynin has low oral bioavailability due to an extensive presystemic metabolism. It has been suggested that the biotransformation of oxybutynin is dependent on CYP3A. Because itraconazole, a widely used mycotic, is a potent inhibitor of CYP3A4, we wanted to study a possible interaction between oxybutynin and itraconazole.

Bioavailability of two clodronate formulations.

Sodium clodronate is effective in the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastasis. Clinical and biochemical data underpin a licensed total daily dose of 1600-3200 mg.

Effect of food on the bioavailability of oxybutynin from a controlled release tablet.

Objective: The effect of food on the bioavailability of oxybutynin was assessed in a randomised cross-over study in 23 healthy volunteers. A single oral 10 mg dose of a controlled release oxybutynin tablet was administered after a high fat breakfast and to fasting subjects. The AUC, Cmax, tmax, t1/2 and MRT of oxybutynin and its active metabolite N-desethyloxybutynin were determined.

The effect of erythromycin on the pharmacokinetics and pharmacodynamics of zopiclone.

1. The effect of erythromycin on the pharmacokinetics and pharmacodynamics of oral zopiclone, a non-benzodiazepine hypnotic, was investigated in a double-blind, cross-over study. 2.

Dose of midazolam should be reduced during diltiazem and verapamil treatments.

1. The effects of diltiazem and verapamil on the pharmacokinetics and pharmacodynamics of midazolam were investigated in a double-blind randomized cross-over study of three phases. 2.

Effects of psychotropic drugs on digit substitution: comparison of the computerized symbol-digit substitution and traditional digit-symbol substitution tests.

The digit-symbol substitution test (DSST), performed with paper and pencil or computerized, is widely used to reveal decrements in human attention and cognition. We programmed sets of adjustable tasks (digit-symbol, digit-digit, symbol-digit, symbol-symbol) into a microcomputer and compared the symbol-digit substitution (SDST) and the digit copying test (DDCT) with the traditional DSST in two placebo-controlled double-blind studies of psychotropic drugs with pre-trained young healthy subjects. Performances were measured before drug intake and several times after it; matched, different codes were used at consecutive tests.

A pharmacokinetic interaction between roxithromycin and midazolam.

The interaction between roxithromycin and midazolam was investigated in a double-blind, randomised crossover study of two phases. Ten healthy volunteers were given roxithromycin (300 mg) or placebo once daily for 6 days. On the sixth day they ingested 15 mg midazolam.

Ethanol inhibits melatonin secretion in healthy volunteers in a dose-dependent randomized double blind cross-over study.

To elucidate the effects of alcohol on pineal rhythmicity, ethanol was administered in the evening in amounts usually consumed during social ingestion to nine healthy volunteers in a double blind, cross-over study. Plasma concentrations of melatonin, catecholamines (norepinephrine and epinephrine), and ethanol were measured by RIA, high pressure liquid chromatography, and gas chromatography before and for 12 h after the administration of 0, 0.5, and 1 g ethanol/kg wt.