Vox sanguinis
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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. ⋯ 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.
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Allogeneic blood transfusions are dose-dependently associated with postoperative complications. Leucocytes present in blood components may play a role in these effects, referred to as transfusion-related immunomodulation. Of 19 randomized controlled trials of the effect of allogeneic leucocytes in transfusions, 13 looked into the effect of leucocyte-containing red blood cells (RBCs) in the surgical setting on the occurrence of postoperative infections and/or mortality. ⋯ The studies performed in cardiac surgery show less heterogeneity than studies in other surgical interventions and had been conducted either in one or a few participating centres. In this review, we discuss possible explanations for these results in cardiac surgery (as opposed to other settings), which may relate to clinical as well as transfusional factors. We suggest that leucocyte-containing transfusions during and after cardiac surgery add a second insult to the cardiopulmonary bypass procedure-induced systemic inflammatory response.
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Review Comparative Study
Rationale for randomized controlled trials and for intention-to-treat analysis in transfusion medicine: are they one and the same?
Articles on the appropriateness of intention-to-treat (ITT) vs. as-treated (AT) analyses of randomized controlled trials (RCTs) have highlighted issues relevant to drug trials, such as approaches suitable for 'explanatory' vs. 'pragmatic' RCTs. These considerations are less relevant to transfusion medicine RCTs, especially those of red blood cell transfusion therapies where the main issue is whether to include in the analysis randomized patients who did not receive transfusion. This article discusses issues pertinent specifically to transfusion medicine RCTs, and the thesis presented here is that the primary analysis of any transfusion medicine RCT must be based on the ITT principle. ⋯ Deviations from the ITT principle may be valid only when other conditions are met to ensure that non-adherence to ITT will not bias the results. For RCTs of red blood cell transfusion therapies, such conditions include that the RCTs be double-blind and that transfusion criteria should be applied consistently. Nonetheless, the rationale for ITT can be reversed in equivalence and non-inferiority trials where the finding of no difference is the objective of the research; thus, both ITT and AT analyses should be presented in these settings.
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Recombinant factor VIIa (rFVIIa) is used for haemophilic patients with inhibitors against coagulation factor VIII or IX, but there is also an off-label use of rFVIIa for patients with massive bleeding. The aim of the present study was to review the randomized clinical trials (RCT) for evidence of such an approach. ⋯ There is little evidence to support routine use of rFVIIa for patients with massive bleeding based on the results of the randomized trials performed. In patients with a normal haemostatic system, administration of rFVIIa may be associated with an increased risk of thromboembolic events.
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Anaemia is a common condition among patients admitted to hospital medicosurgical departments, as well as in critically ill patients. Anaemia is more frequently due to absolute iron deficiency (e.g. chronic blood loss) or functional iron deficiency (e.g. chronic inflammatory states), with other causes being less frequent. In addition, preoperative anaemia is one of the major predictive factors for perioperative blood transfusion. ⋯ Intravenous iron administration seems to be safe, as very few severe side-effects were observed, and may result in hastened recovery from anaemia and lower transfusion requirements. However, it is noteworthy that many of the recommendations given for intravenous iron treatment are not supported by a high level of evidence and this must be borne in mind when making decisions regarding its application to a particular patient. Nonetheless, this also indicates the need for further large, randomized controlled trials on the safety and efficacy of intravenous iron for the treatment of anaemia in different clinical settings.