International haemovigilance: what have we learned and what do we need to do next?

The International Haemovigilance Network (IHN) defines haemovigilance as 'a set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence'. IHN, the International Society of Blood Transfusion and World Health Organization work together to support both developing and established haemovigilance systems. Haemovigilance systems provide valuable data on a range of adverse events related to blood donation and clinical transfusion, from donor syncopal events to transfusion-transmitted infections, immunological complications and the impact of human errors. Harmonised definitions for most adverse reactions have been developed and validated internationally. Definitions of pulmonary complications are again under review. Haemovigilance data have resulted in changes in policy, products and practice, and can complement and inform clinical audit and research, leading to improved blood donor safety, optimised product use and better clinical outcomes after transfusion. However, more work is needed. Not all countries have haemovigilance systems in place. More robust data and careful analysis are required to improve the understanding of the causes, occurrence and clinical outcomes of these events. Wider dissemination of results will facilitate health policy development internationally, and implementation of haemovigilance recommendations will support further important progress in blood safety.

Monitoring and treatment of anti-D in pregnancy.

Prophylactic anti-D is a very safe and effective therapy for the suppression of anti-D immunization and thus prevention of haemolytic disease of the foetus and newborn. However, migration from countries with low health standards and substantial cuts in public health expenses have increased the incidence of anti-D immunization in many "developed" countries. Therefore, this forum focuses on prenatal monitoring standards and treatment strategies in pregnancies with anti-D alloimmunization. The following questions were addressed, and a response was obtained from 12 centres, mainly from Europe.

Quality assurance of the donor questionnaire and donor interview: a three year experience with an electronic donor questionnaire.

Quality assurance of the donor questionnaire and the donor interview must ensure that all relevant questions about donor eligibility are answered and documented in a reliable format. The use of the self explanatory, electronic donor information tool [EDIT], not only provided a harmonized and standardised system of quality assurance but also saved time and can be easily modified as guidelines change. This brief report highlights the principles of this tool and some of its potential benefits, as experienced over the 3 years since its introduction in Norway.

A comparison of complication rates based on published haemovigilance data.

UNLABELLED: Haemovigilance is defined as the collection of information on complications of transfusion, the analysis of the data, and suggestions for improvement in the transfusion service. A national haemovigilance system is of value in identifying possible areas in need of improvement in the national transfusion system. Haemovigilance becomes even more important if the system is used to compare the situation in one country with the situation in other countries, e.g. if the countries differ significantly in products used. The current study focuses on immunological transfusion complications, especially TRALI, as published in haemovigilance reports from Denmark, Norway, Sweden and the UK. RESULTS: In Norway immunological transfusion reactions occurred 96.7 times per 100 000 red cell (RBC) transfusion, 231.1 times per 100 000 thrombocyte (Trc) concentrate transfusion and five times per 100.000 transfusions of solvent detergent treated plasma (SD plasma). Denmark and the UK have similar rates of transfusion reactions to RBC and fresh frozen plasma (FFP), but quite different for Trc (0.5 vs. 4.9 per 100 000). In 49% of reported TRALI the causative product is FFP, but no case of TRALI after SD plasma transfusion has been reported. DISCUSSION: When considering all reports for immunological complications in Norway, the most striking is the very small number of reports related to SD plasma. Comparing data from Denmark and the UK shows a big difference in reactions caused by thrombocyte concentrates that may reflect different production methods in the two countries. TRALI is most often caused by FFP, but has never been reported after SD plasma transfusion. Heamovigilance data can be valuable in choosing the safest products available.

Commentary on the 5th annual course in Transfusion Medicine arranged by the Norwegian Red Cross Blood Programme.

This commentary deals briefly with various topics discussed in the recent annual course in Transfusion Medicine, organized by the Norwegian Red Cross Blood Programme.

Inflammation and coronary angiography in asymptomatic type 2 diabetic subjects.

OBJECTIVE: Coronary artery disease (CAD) is prevalent in patients with type 2 diabetes mellitus (T2DM) and because it is often asymptomatic and extensive in comparison with CAD in subjects without diabetes, it represents a diagnostic challenge. The objective of the study was to investigate the prevalence of CAD in asymptomatic T2DM patients utilizing angiography and to investigate its association with cardiovascular (CV) risk factors, the metabolic syndrome and markers of inflammation. MATERIAL AND METHODS: Eighty-two patients with T2DM without symptoms of CAD, and with >or=1 CV risk factor (hypertension, dyslipidaemia, premature familial CAD, smoking or microalbuminuria) underwent a diagnostic stress test and coronary angiography irrespective of stress test results. Stenosis detected in the main coronary arteries >or=50% of lumen diameter was categorized as one-, two- or three-vessel disease. Inflammatory markers were analysed in fasting samples. RESULTS: Fifteen men and two women had significant CAD (21%) (1-vessel disease, n=10; 2- or 3-vessel disease, n=7). Patients with 2- or 3-vessel disease were significantly older and had a longer duration of diabetes, but the prevalence of other traditional CV risk factors or the metabolic syndrome was similar among those with 1-vessel and those with 2- or 3-vessel disease. Sensitivity for CAD of the stress test was low (0.35). The mean level of the pro-inflammatory marker interleukin-6 was elevated in patients with 2- to 3-vessel CAD as compared to patients with no or 1-vessel CAD (p<0.05). CONCLUSIONS: Significant CAD was found in 21% of asymptomatic patients with T2DM with >or=1 CV risk factor. Inflammatory markers may be helpful in identifying patients that are likely to have significant CAD, but larger studies are warranted.

Transfusion medicine in Norway: new problems and new opportunities.

During 2005 Norwegian Transfusion Medicine has faced some new problems, sought new solutions and gained strength. Interactions with the public and the health authorities have been important issues for consideration, which are discussed below.

Current issues in transfusion medicine in Norway.

Important current issues in transfusion medicine in Norway are discussed. Current patient legislation specifically defines blood donors as patients, and blood and blood products are defined as drugs. Donor selection is controversial, especially deferral of all persons born in, or having lived for more than one year in areas with high prevalence of infections that are transmitted by blood. The threshold for becoming a blood donor is high, but registered donors donate frequently, e.g. 2,4 whole blood donations per year on average. Some blood banks have specialized in multicomponent aphereis technology, in particular collection of two units of red cells.

Clinical implications of red blood cell and platelet storage lesions: an overview.

Both red blood cells and platelets undergo lesions upon storage which affect their function and possibly their clinical outcome. Some of these lesions are reversible, others not. Improved additive solutions and leukocyte depletion can delay the appearance of storage lesions. In addition, cellular apoptosis leads to numerous mitochondrial and surface changes during storage which have the potential to induce immune suppression by tuning down the innate immune system. This overview highlights some laboratory and clinical aspects of red cell and platelet storage lesions.