[Cell salvage : Scientific evidence, clinical practice and legal framework]. / Maschinelle Autotransfusion : Wissenschaftliche Evidenz, klinische Praxis und rechtliche Rahmenbedingungen.

Cell salvage is an efficient method to reduce the transfusion of homologous banked blood, as documented by several meta-analyses detected in a systematic literature search. Cell salvage is widely used in orthopedics, trauma surgery, cardiovascular and abdominal transplantation surgery. The retransfusion of unwashed shed blood from wounds or drainage is not permitted according to German regulations. Following irradiation of wound blood, salvaged blood can also be used in tumor surgery. Cell salvage makes a valuable contribution to providing sufficient compatible blood for transfusions in cases of massive blood loss. Certain surgical procedures for Jehovah's Witnesses are only possible with the use of cell salvage. Another possible use is the washing of homologous banked blood, e. g. to prevent potassium-induced arrhythmia or sequestration of autologous platelets. Other advantages besides a good compatibility are the high vitality and functionality of the unstored autologous red blood cells. These have been declared a pharmaceutical product by the German transfusion task force in 2014, so that the autologous red blood cells are now under the control of the Pharmaceutical Products Act (AMG). The new hemotherapy guidelines, however, tolerate cell salvage only under strict rules, whereby the production of autologous blood during or after surgery is still possible without additional special permits. The new guidelines now require the introduction of a quality management system for cell salvage and regular quality controls. These quality controls include a control of the product hematocrit for every application, monthly controls of the protein and albumin elimination rates and the erythrocyte recovery rate for each cell salvage device. Testing for infection markers is not required. The application of cell salvage has to be reported to the appropriate authorities.

Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations.

Several major orthopaedic surgical procedures may result in significant blood loss and the need for allogeneic blood transfusion (ABT). However, overall concerns about adverse effects of ABT have prompted the review of transfusion practice and the search for transfusion alternatives to decrease or avoid the use of ABT. These strategies include the correction of perioperative anaemia, pharmacological and non-pharmacologic measures to reduce blood loss, preoperative autologous blood donation and perioperative red blood cell salvage. We have reviewed the efficacy and safety of these strategies and where appropriate offer evidence-based recommendations on their use in orthopaedic surgery. We also reviewed the European regulations on ABT alternatives. Pharmacological alternatives need to be used with a total adherence to European regulations in their legal and off-label use. The administration and use of pharmacological agents to stimulate erythropoiesis or reduce blood loss needs to be within the context of attempting to use allogenic blood in a rational manner. As for autologous blood, European Directives cover preoperative autologous blood donation, but not its clinical use, and perioperative red blood cell salvage devices, but not the product yielded by them. Therefore, the development of quality standards and good practice guidelines for perioperative red blood cell salvage, as well as its inclusion in the haemovigilance programme, is urgently needed. Finally, it is noteworthy that some recommendations given for ABT alternatives are not supported by a high level of evidence and that the goal of performing major orthopaedic surgical procedures without the use of ABT may be better accomplished by combining several of these techniques within a defined algorithm.

[Autohemotherapy, state intervention and bioethics]. / Auto-hemoterapia, intervenção do estado e bioética.

The increasingly frequent practice of autohemotherapy entails a potential risk to the health of individuals since it is scientifically unproven. There are practically no clinical studies showing the efficacy and safety of this procedure; only experimental research with questionable results from studies on human beings and animals. Over the last years, the sanitary surveillance area has expanded its preventive and risk control actions based upon a precautionary philosophy in the private as well as the public sphere. By observing the theoretical and practical reference points of the "four Ps" (prevention, protection, precaution and prudence), in accordance with the epistemology developed within Intervention Bioethics, sanitary surveillance actions are based upon legal administrative policing powers. These powers are understood to be the Public Administration's competence to set conditions on and restrict the use and benefit of goods, activities and individual rights, on behalf of the common well being of people or the State itself. The Brazilian State, through its sanitary surveillance policing powers at the three levels of government, has intervened in the practice of autohemotherapy. Considering the responsible State intervention in situations of collective interest, vulnerability and susceptibility, the present study proposed to analyze the practice of autohemotherapy in the light of sanitary surveillance actions and their relationship with the "four Ps" of Intervention Bioethics.

Legal and ethical considerations in the transfusion of infected or untested autologous blood.

Autologous blood transfusion grew in popularity in response to the recognition of transfusion-transmitted HIV and a lack of effective screening. Laboratory screening and donor deferrals have decreased the need for autologous transfusion. The issue of banking blood that has not been tested or has been tested and found positive for serious infectious diseases raises ethical and legal issues that must be addressed by transfusion services, transfusion committees, physicians, and administrators. This article provides a summary of pertinent federal and state laws regarding autologous blood transfusion and a framework to assess the ethical implications of various strategies.

Preoperative autologous blood donation: clinical, economic, and ethical issues.

Many patients are donating their own blood before surgery to avoid blood-borne infections, often on the advice of their physicians. But autologous blood transfusion, while safer than allogeneic transfusion, is not completely risk-free. It is also expensive, its benefits are difficult to assess, and its increasing popularity raises many difficult ethical issues, such as whether the benefit of allogeneic transfusion supports its additional expense. Record-keeping, collection, and transfusion errors are occasional risks of autologous transfusions. In addition, risks associated with blood donation, from mild dizziness to precipitation of angina, should be considered when high-risk patients are referred for autologous collection. Only approximately half of autologous units collected are actually used, and the cost per quality-adjusted year of life saved may be as high as $1 million, depending on the type of surgical procedure. Although recombinant human erythropoietin can stimulate red blood cell production before autologous donation and decrease the need for transfusion, it is not clear whether this strategy, which can cost thousands of dollars per patient, will be cost-effective. Perioperative hemodilution may become an important component in efforts to reduce patient exposure to allogeneic blood, but its use remains controversial.

Practice of autologous preoperative plasmapheresis in Germany in 1993.

Autologous preoperative plasmapheresis which is being performed at the University Hospital of Tübingen since 1984 in advance of surgical, orthopaedic or gynecologic operations, constitutes, in combination with intraoperative autotransfusion (IAT), an optimal method to compensate high losses of intravascular volume. Unlike all other procedures which also substitute lost volume (such as infusion of electrolytic solutions or plasma expanders, haemodilution, retransfusion of preoperatively donated autologous blood, transfusion of homologous plasma or foreign blood) this method grants optimal clotting as well as intravascular retention of volume and in addition to this excludes every risk of infection. Although the therapeutic advantages of autologous preoperative plasmapheresis are well known and confirmed by our statistics (about 75% of the patients do not need any foreign blood), the method is rarely practiced in Germany and mainly performed in specialized hospitals (e.g. in the orthopaedic departments of Tübingen, Ulm, Hamburg, Hannover or Essen). This unfortunate situation is obviously due to some of the following, primarily logistic problems. First of all the procedure of autologous preoperative plasmapheresis needs relatively long planning in advance of the operation (between 2 and 4 weeks) and a number of surgeons renounces the method--even if the patient's medical condition is appropriate and no higher costs are to be expected. The above mentioned alternatives of compensating blood losses are preferred, even if they are in no way comparable in their efficiency. Secondly, in Germany autologous preoperative plasmapheresis is mostly performed by an anaesthetist, who is, however, under our laws obliged to reinfuse the plasma himself, which he has taken from a patient.(ABSTRACT TRUNCATED AT 250 WORDS)

[Preoperative autologous blood donation and disposition. Possibilities and prerequisites]. / Präoperative Eigenblutspende und-bereitstellung. Möglichkeiten und Voraussetzungen.

Preoperative blood deposit can help to avoid the risks of homologous blood transfusions. However, it is necessary that prerequisites concerning medicine standard, organisation, technical questions and administrative aspects have to be fulfilled.

[Autologous blood transfusion]. / Transfusion sanguine autologue.

Autologous blood transfusion techniques are the principal means of reducing allogeneic blood exposure. Those techniques were developed in order to prevent the risk of contamination by viruses, mainly HVB, HCV and HIV. However that risk has become so small that all studies show an exorbitant cost/efficiency ratio. Autologous blood transfusion would therefore be of no interest in terms of public health but a recent experimental study suggested a possible transmission of the BSE agent through blood. Until the matter is settled, the precaution principle means we should prefer alternative techniques to allogeneic blood whenever possible, hence a renewed interest in autologous transfusion.

Circulating microRNAs as biomarkers for detection of autologous blood transfusion.

MicroRNAs (miRNAs) are small non-coding RNAs that regulate various biological processes. Cell-free miRNAs measured in blood plasma have emerged as specific and sensitive markers of physiological processes and disease. In this study, we investigated whether circulating miRNAs can serve as biomarkers for the detection of autologous blood transfusion, a major doping technique that is still undetectable. Plasma miRNA levels were analyzed using high-throughput quantitative real-time PCR. Plasma samples were obtained before and at several time points after autologous blood transfusion (blood bag storage time 42 days) in 10 healthy subjects and 10 controls without transfusion. Other serum markers of erythropoiesis were determined in the same samples. Our results revealed a distinct change in the pattern of circulating miRNAs. Ten miRNAs were upregulated in transfusion samples compared with control samples. Among these, miR-30b, miR-30c, and miR-26b increased significantly and showed a 3.9-, 4.0-, and 3.0-fold change, respectively. The origin of these miRNAs was related to pulmonary and liver tissues. Erythropoietin (EPO) concentration decreased after blood reinfusion. A combination of miRNAs and EPO measurement in a mathematical model enhanced the efficiency of autologous transfusion detection through miRNA analysis. Therefore, our results lay the foundation for the development of miRNAs as novel blood-based biomarkers to detect autologous transfusion.

[Legal aspects of preparation and handling of concentrated red cells derived from placental blood in Germany]. / Juristische Aspekte bei der Herstellung und Verwendung von Plazentablut-Erythrozytenkonzentraten in Deutschland.

Legal aspects of collection, preparation and storage of autologous red cells derived from cord blood according to German law are presented and discussed.

[Autologous blood donation and isovolemic hemodilution--indications and practical implementation]. / Eigenblutspende und isovolämische Hämodilution--Indikationen und praktische Durchführung.

OBJECTIVE: The state of the art of autologous blood transfusion is described with special emphasis on safety aspects, indications and medicolegal implications. DATA SOURCES AND SELECTION CRITERIA: Literature was retrieved using the MEDLINE literature database. Medical and legal expert opinions on autologous blood transfusion programmes are presented as well as the actual German jurisdiction. Guidelines for autologous predeposit and haemodilution used in the University of Münster are described. RESULTS: In the past decade all forms of autologous transfusions gained increasing influence in haemotherapy due to the ongoing discussion on the safety of blood products. The German Federal Court has demanded that whenever homologous perioperative transfusion is considered likely, patients have to be offered autologous predeposit. Legal conditions for autologous programmes directed by anaesthetists not specialised in transfusion medicine are described. Whole-blood predeposit should be limited to two autologous units. In cases with minor blood loss, isovolaemic haemodilution may be performed instead of autologous predeposit. However, autologous transfusions have their specific risks that are either related to the patient or to the procedure of autologous predeposit, e.g., clerical error, contamination of blood products and technical faults. Standard procedures of the University of Münster to ensure low-risk autologous transfusion are presented. They consist in adequate handling and proper identification, testing of donor for virus infection markers, bacterial culture from blood products and a list of contraindications: anaemia, unstable angina, myocardial infarction within 3 months, decompensated heart insufficiency, aortic valve stenosis with angina, and cases with infection and fever. CONCLUSION: The risks related with autologous transfusion should be lower compared to homologous transfusions. Well-defined standards concerning indications and techniques are required to reach this goal.