Safety and effectiveness of a prothrombin complex concentrate in approved and off-label indications.

OBJECTIVE: To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off-label indications. BACKGROUND: PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off-label indications are limited, but they are included in massive bleeding protocols. METHODS: This was a retrospective review of cases treated with four-factor PCCs (4F-PCCs) between January 2009 and 2016. Efficacy end-points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24-h mortality in bleeding coagulopathy. The safety end-point is the incidence of thromboembolic events. RESULTS: A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered (P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of other coagulopathies; 24-h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%). CONCLUSION: 4F-PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.

Pre-operative haemoglobin levels and iron status in a large multicentre cohort of patients undergoing major elective surgery.

Pre-operative anaemia in patients undergoing major surgical procedures has been linked to poor outcomes. Therefore, early detection and treatment of pre-operative anaemia is recommended. However, to effectively implement a pre-operative anaemia management protocol, an estimation of its prevalence and main causes is needed. We analysed data from 3342 patients (44.5% female) scheduled for either: elective orthopaedic surgery (n = 1286); cardiac surgery (n = 691); colorectal cancer resection (n = 735); radical prostatectomy (n = 362); gynaecological surgery (n = 203) or resection of liver metastases (n = 122). For both sexes, anaemia was defined by a haemoglobin level < 130 g.l-1 ; absolute iron deficiency by ferritin < 30 ng.ml-1 (< 100 ng.ml-1 , if transferrin saturation < 20% or C-reactive protein > 5 mg.l-1 ); iron sequestration by transferrin saturation < 20% and ferritin > 100 ng.ml-1 ; and low iron stores by transferrin saturation > 20% and ferritin 30-100 ng.ml-1 . The overall prevalence of anaemia was 36%, with differences according to the type of surgery. Laboratory parameters allowing classification of iron status were available for 2884 patients. Among those with anaemia (n = 986), 677 (69%) were women, 608 (62%) presented with absolute iron deficiency, 101 (10%) with iron sequestration; and 150 (5%) with low iron stores. Iron status alterations were similar in women with haemoglobin < 130 g.l-1 or < 120 g.l-1 . For those who were not anaemic (n = 1898), corresponding figures were 656 (35%), 621 (33%), 165 (9%) and 518 (27%), respectively. Anaemia was present in one-third of patients undergoing major elective procedures. Over two-thirds of anaemic patients presented with absolute iron deficiency or iron sequestration. Over half of non-anaemic patients presented with absolute iron deficiency or low iron stores. We consider these data useful for planning pre-operative management of patients scheduled for major elective surgery.

Forum for debate: Safety of allogeneic blood transfusion alternatives in the surgical/critically ill patient.

In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues.

Utility and cost of low-vacuum reinfusion drains in patients undergoing surgery for subcapital hip fracture repair. A before and after cohort study.

BACKGROUND: Postoperative blood loss may be a risk factor for allogeneic blood transfusion (ABT) in patients undergoing subcapital hip fracture (SHF) repair. We investigated the utility and costs of using a low-vacuum reinfusion drain (Bellovac ABT) within a blood management protocol for reducing ABT requirements in consecutive SHF. METHODS: The blood management protocol consisted of the application of a restrictive transfusion trigger (Hb < 8 g/dl), the peri-operative administration of IV iron sucrose (3 × 200 mg/48 h) ± recombinant erythropoietin (1 × 40 000 IU sc) and the use of Bellovac ABT (Group 2, n = 117). An immediate previous SHF series managed without Bellovac ABT served as control (Group 1, n = 138). RESULTS: Overall, 72 out of 255 (28%) received at least one ABT unit (2·1 ± 1·0 U/transfused patient) without differences between groups. However, in the subgroup of patients with admission Hb < 13 g/dl, the use of Bellovac ABT reduced postoperative ABT rates (16% vs. 46%, for groups 2 and 1, respectively; P = 0·001), although only 3 were reinfused, and was cost-saving. The use of Bellovac ABT also resulted in fewer wound bleeding complications, but there were no differences in Hb at postoperative days 7 and 30 between groups. CONCLUSIONS: In SHF patients with admission Hb < 13 g/dl and managed with peri-operative IV iron ± recombinant erythropoietin plus restrictive transfusion indication, the use of Bellovac ABT was associated with reduced ABT requirements, without increasing postoperative complications, and cost-savings.

Management of peri-surgical anemia in elective surgery. Conclusions and recommendations according to Delphi-UCLA methodology.

INTRODUCTION: Preoperative anemia affects approximately one third of surgical patients. It increases the risk of blood transfusion and influences short- and medium-term functional outcomes, increases comorbidities, complications and costs. The "Patient Blood Management" (PBM) programs, for integrated and multidisciplinary management of patients, are considered as paradigms of quality care and have as one of the fundamental objectives to correct perioperative anemia. PBM has been incorporated into the schemes for intensified recovery of surgical patients: the recent Enhanced Recovery After Surgery 2021 pathway (in Spanish RICA 2021) includes almost 30 indirect recommendations for PBM. OBJECTIVE: To make a consensus document with RAND/UCLA Delphi methodology to increase the penetration and priority of the RICA 2021 recommendations on PBM in daily clinical practice. MATERIAL AND METHODS: A coordinating group composed of 6 specialists from Hematology-Hemotherapy, Anesthesiology and Internal Medicine with expertise in anemia and PBM was formed. A survey was elaborated using Delphi RAND/UCLA methodology to reach a consensus on the key areas and priority professional actions to be developed at the present time to improve the management of perioperative anemia. The survey questions were extracted from the PBM recommendations contained in the RICA 2021 pathway. The development of the electronic survey (Google Platform) and the management of the responses was the responsibility of an expert in quality of care and clinical safety. Participants were selected by invitation from speakers at AWGE-GIEMSA scientific meetings and national representatives of PBM-related working groups (Seville Document, SEDAR HTF section and RICA 2021 pathway participants). In the first round of the survey, the anonymized online questionnaire had 28 questions: 20 of them were about PBM concepts included in ERAS guidelines (2 about general PBM organization, 10 on diagnosis and treatment of preoperative anemia, 3 on management of postoperative anemia, 5 on transfusion criteria) and 8 on pending aspects of research. Responses were organized according to a 10-point Likter scale (0: strongly disagree to 10: strongly agree). Any additional contributions that the participants considered appropriate were allowed. They were considered consensual because all the questions obtained an average score of more than 9 points, except one (question 14). The second round of the survey consisted of 37 questions, resulting from the reformulation of the questions of the first round and the incorporation of the participants' comments. It consisted of 2 questions about general organization of PBM programme, 15 questions on the diagnosis and treatment of preoperative anemia; 3 on the management of postoperative anemia, 6 on transfusional criteria and finally 11 questions on aspects pending od future investigations. Statistical treatment: tabulation of mean, median and interquartiles 25-75 of the value of each survey question (Tables 1, 2 and 3). RESULTS: Except for one, all the recommendations were accepted. Except for three, all above 8, and most with an average score of 9 or higher. They are grouped into: 1.- "It is important and necessary to detect and etiologically diagnose any preoperative anemia state in ALL patients who are candidates for surgical procedures with potential bleeding risk, including pregnant patients". 2.- "The preoperative treatment of anemia should be initiated sufficiently in advance and with all the necessary hematinic contributions to correct this condition". 3.- "There is NO justification for transfusing any unit of packed red blood cells preoperatively in stable patients with moderate anemia Hb 8-10g/dL who are candidates for potentially bleeding surgery that cannot be delayed." 4.- "It is recommended to universalize restrictive criteria for red blood cell transfusion in surgical and obstetric patients." 5.- "Postoperative anemia should be treated to improve postoperative results and accelerate postoperative recovery in the short and medium term". CONCLUSIONS: There was a large consensus, with maximum acceptance,strong level of evidence and high recommendation in most of the questions asked. Our work helps to identify initiatives and performances who can be suitables for the implementation of PBM programs at each hospital and for all patients.

[The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document]. / 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: « Does this particular AABT reduce the transfusion rate or not?¼ All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology.

Preoperative hemogram as a predictive factor for iron deficit and/or transfusion in patients scheduled for arthroplasty.

INTRODUCTION: anemia and iron deficiency predispose to an increased risk of transfusion with a consequent increase in morbidity and mortality. The study analyzes whether blood cell count parameters in addition to detecting anemia can predict iron deficiency and/or transfusional risk in patients undergoing mostly to scheduled primary hip and knee arthroplasty. OBJECTIVE: To analyze how blood cell count parameters predict iron deficiency and/or transfusional risk in patients undergoing programmed arthroplasty. MATERIAL AND METHODS: The analytical and transfusion results of 522 patients undergoing arthroplasty have been prospectively collected between 2013 and 2019 and the discriminative and predictive capacity of the basic parameters of the red cells have been analyzed; hemoglobin (Hb), mean cell volume, mean cell hemoglobin (HCM) and red blood cell distribution width (RDW) for the identification of presurgical iron deficiency and postsurgical transfusion. RESULTS: Anaemia was detected in 6.6%, "suboptim" Hb (<13 g/dL) in 14.5% and iron deficiency in 32.4%. Anemia detects only 13.8% of ID. After logistic regression analysis, the multivariate model significantly related Hb (p = .004), mean corpuscular hemoglobin (MCH) (p = .026), and the red cell distribution width (RDW) (p = .001) with ID; but mean corpuscular volume (MCV) is not significant. Hb, age and transferrin saturation index have been the only risk factors for transfusional risk of the parameters analyzed. CONCLUSIONS: The hemogram contains parameters that correlate with iron deficiency, however, mean cell volume, so widely used for the orientation of iron deficiency, is not valid as a discriminator of iron deficiency in this group of patients. Low Hb and transferrin saturation index are modifiable predictors for transfusion risk.

Preoperative hemogram as a predictive factor for iron deficit and/or transfusion in patients scheduled for arthroplasty. / El hemograma como factor predictivo de déficit de hierro y/o transfusión en paciente pendiente de artroplastia.

INTRODUCTION: Anemia and iron deficiency predispose to an increased risk of transfusion with a consequent increase in morbidity and mortality. The study analyzes whether blood cell count parameters in addition to detecting anemia can predict iron deficiency and/or transfusional risk in patients undergoing mostly to scheduled primary hip and knee arthroplasty. OBJECTIVE: To analyze how blood cell count parameters predict iron deficiency and/or transfusional risk in patients undergoing programmed arthroplasty. MATERIAL AND METHODS: The analytical and transfusion results of 522 patients undergoing arthroplasty have been prospectively collected between 2013 and 2019 and the discriminative and predictive capacity of the basic parameters of the red cells have been analyzed; hemoglobin (Hb), mean cell volume, mean cell hemoglobin (HCM) and red blood cell distribution width (RDW) for the identification of presurgical iron deficiency and postsurgical transfusion. RESULTS: Anaemia was detected in 6.6%, "suboptim" Hb (<13g/dL) in 14.5% and iron deficiency in 32.4%. Anemia detects only 13.8% of ID. After logistic regression analysis, the multivariate model significantly related Hb (p=.004), mean corpuscular hemoglobin (MCH) (p=.026), and the red cell distribution width (RDW) (p=.001) with ID; but mean corpuscular volume (MCV) is not significant. Hb, age and transferrin saturation index have been the only risk factors for transfusional risk of the parameters analyzed. CONCLUSIONS: The hemogram contains parameters that correlate with iron deficiency, however, mean cell volume, so widely used for the orientation of iron deficiency, is not valid as a discriminator of iron deficiency in this group of patients. Low Hb and transferrin saturation index are modifiable predictors for transfusion risk.

Sedimentation method for preparation of postoperatively salvaged unwashed shed blood in orthopaedic surgery.

BACKGROUND: Salvage and return of unwashed shed blood (USB) after total knee replacement (TKR) is an established blood-saving technique, but some authors question its efficacy and safety and suggest that the shed blood be washed before returning. We evaluated a colloid-based sedimentation method for improving and standardizing the quality of USB collected after TKR without the need for washing. METHODS: Experiments were performed to find the optimal colloid dose and sedimentation time using diluted donated venous blood. USB samples (n=52) were drawn from the reinfusion bag and mixed with hydroxyethyl starch or gelatine solutions (15-30%, colloid solution volume/total volume × 100). USB red blood cells (RBCs) were allowed to settle by gravity for 30 min, supernatant was evacuated from the syringe, and RBC concentrate was analysed. RBC recovery and other blood cell and chemical removal were calculated according to changes in USB volume and haematocrit. Twenty-five samples from leucodepleted packed RBCs were analysed as a comparator group. RESULTS: Mean haemoglobin (Hb) of USB was 10.9 g dl(-1). After colloid treatment, 90% of RBCs were recovered, and USB Hb was similar to that of leucodepleted packed RBCs (n=25) (18.9 vs 19.6 g dl(-1), respectively; P=NS). In addition, the procedure reduced USB content of leucocytes (60%), platelets (48%), total protein (76%), cytokines (70-77%), and plasma-free haemoglobin (53%), without major differences between colloids. CONCLUSIONS: Sedimentation of USB with colloid solutions provides a low-cost alternative for improving and standardizing the quality of salvaged USB after TKR.

Management of iron deficiency in various clinical conditions and the role of intravenous iron: Recommendations of the Spanish Erythropathology Group of the Spanish Society of Haematology and Haemotherapy. / Manejo del déficit de hierro en distintas situaciones clínicas y papel del hierro intravenoso: recomendaciones del Grupo Español de Eritropatología de la SEHH.

Iron deficiency due to blood loss, absorption disorders and dietary deficiencies causes iron-deficiency anaemia, whose treatment seeks to eliminate the underlying cause and restore haemoglobin and iron deposits. Typically, the latter 2 of these objectives can be achieved through oral iron therapy. Intravenous iron administration (IIA) should be limited to those patients refractory or intolerant to oral preparations or who require rapid repletion. The indiscriminate use of IIA can increase morbidity and mortality due to iatrogenic overload. This fact, coupled with the growing popularity of IIA and the lack of reference guidelines in Spanish, led the Spanish Erythropathology Group of the Spanish Society of Haematology and Haemotherapy to develop this study, which presents the main recommendations on the optimal use of IIA in iron deficiency and attempts to constitute reference guidelines on good practices for the clinical management of these conditions.

Transfusions in the Emergency department: More than a blood transfusion. / Transfusión en Urgencias: algo más que una transfusión de sangre.

Increasing haemoglobin and haematocrit levels with blood transfusions has been the gold standard for treating severe anaemia; however, the indication for transfusing concentrated red blood cells is based merely on a few laboratory markers, such as haemoglobin and haematocrit levels, rather than based on the symptoms according to clinical practice guidelines, the implementation of legal regulations and the consensus achieved by the hospitals' transfusion committees. The aim of this multicentre study was to reassess the suitability of the indication for transfusing concentrated red blood cells and the volumes transfused in emergency departments. We established an observational, multicentre, cross-sectional design with 2 participating centres: the La Paz University Hospital and the Hospital of Salamanca. In total, we obtained data from 381 patients, 220 (57.74%) of whom were men with an average age of 71.4±14.0 years and 161 (42.26%) of whom were women with an average age of 75.3±15.3 years (P<.001). The most prevalent underlying diseases in the patients who underwent transfusions were heart disease, which included haemorrhaging due to antiplatelet or anticoagulant therapy (57.7%), haemato-oncologic (15.3%) diseases and neurological disease. Only 54.9% (209/381) of the prescriptions for transfusion were considered appropriate, with significant differences according to the indication.

Patient Blood Management for primary hip and knee replacement. A survey among POWER.2 study researchers. / Patient Blood Management en artroplastia primaria de cadera y rodilla. Encuesta entre los investigadores del estudio POWER.2.

BACKGROUND: Implementation of Patient Blood Management programs remain variable in Europe, and even in centres with well-established PBM programs variability exists in transfusion practices. OBJECTIVES AND METHODS: We conducted a survey in order to assess current practice in perioperative Patient Blood Management in patients undergoing total hip and knee replacement among researchers involved in POWER.2 Study in Spain (an observational prospective study evaluating enhanced recovery pathways in orthopaedic surgery). RESULTS: A total of 322 responses were obtained (37.8%). Half of responders check Haemoglobin levels in patients at least 4 weeks before surgery; 35% treat all anaemic patients, although 99.7% consider detection and treatment of preoperative anaemia could influence the postoperative outcomes. Lack of infrastructure (76%) and lack of time (51%) are the main stated reasons not to treat anaemic patients. Iron status is routinely checked by 19% before surgery, and 36% evaluate it solely in the anaemic patient. Hb<9.9 g/dl is the threshold to delay surgery for 61% of clinicians, and 22% would consider transfusing preoperatively clinically stable patients without active bleeding. The threshold to transfuse patients without cardiovascular disease is 8 g/dl for 43%, and 7 g/dl for 34% of the responders; 75% of clinicians consider they use "restrictive thresholds", and 90% follow the single unit transfusion policy. CONCLUSIONS: The results of our survey show variability in clinical practice in Patient Blood Management in major orthopaedic surgery, despite being the surgery with the greatest tradition in these programs.

Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. / Auditoría nacional de complicaciones después de la cirugía gástrica por cáncer dentro o no de un protocolo de recuperación intensificada (POWER.4): Protocolo de un estudio prospectivo, multicéntrico, observacional de cohortes.

BACKGROUND AND OBJECTIVE: Enhanced recovery pathways or ERAS have been applied in gastric cancer surgery extrapolated from colorectal surgery. The objective of the study is to assess postoperative complications 30 days after gastric surgery for cancer, with any level of compliance with the ERAS protocol. The secondary objectives are to assess 30-day mortality, the relationship between adherence to the ERAS protocol and complications, the impact of each of the items of the protocol on postoperative complications and hospital stay, and to describe the impact of complications on length of hospital stay. MATERIALS AND METHODS: Multicenter, observational, prospective study including all consecutive patients undergoing scheduled gastric cancer surgery, over a period of 3 months, with a 30-day follow-up at participating centers, with any level of compliance with the protocol. RESULTS: The approval of the Comité Autonómico de Ética de la Investigación de Aragón has been obtained (C.P. - C.I. PI19 / 106, 27 th March 2019). POWER.4 was registered at www.clinicaltrials.gov on March 7, 2019 (NCT03865810). CONCLUSIONS: The data as a whole will be published in peer-reviewed journals. The data will not be made public by identifying each participating center. It is expected that the results of this study will identify potential areas for improvement in which more targeted research is needed.

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.

Efficacy of preoperative recombinant human erythropoietin administration for reducing transfusion requirements in patients undergoing surgery for hip fracture repair. An observational cohort study.

BACKGROUND: Preoperative anaemia is a major risk factor for allogeneic blood transfusion (ABT) in patients undergoing hip fracture repair. We investigated the efficacy of preoperative recombinant human erythropoietin (rHuEPO) administration for reducing ABT requirements in a series of consecutive hip fracture patients presenting with haemoglobin (Hb) between 10 g/dl and 13 g/dl. METHODS: The blood conservation protocol consisted of the application of a restrictive transfusion trigger (Hb < 8 g/dl) and the perioperative administration of intravenous iron sucrose (3 x 200 mg/48 h) (group 1, n = 115). Additionally, some patients received preoperative rHuEPO (40 000 IU sc) on admission to the orthopaedic ward (group 2, n = 81). RESULTS: Overall, 103 of 196 patients (52.5%) received at least one ABT unit (2.1 +/- 1.0 U/patient). However, there were significant differences in perioperative ABT rates between groups (60% vs. 42%, for groups 1 and 2, respectively; P = 0.013). Postoperative Hb on postoperative days 7 and 30 was higher in group 2 than in group 1. In addition, in group 2, Hb levels were higher on postoperative day 30 than on admission (12.7 +/- 1.0 g/dl vs. 11.9 +/- 0.8 g/dl, respectively; P = 0.030). Administration of rHuEPO did not increase postoperative complications or 30-day mortality rate. Only three mild intravenous iron adverse effects were witnessed. CONCLUSIONS: In anaemic hip fracture patients managed with perioperative intravenous iron and restrictive transfusion protocol, preoperative administration of rHuEPO is associated with reduced ABT requirements. However, appropriate training, education and awareness are needed to avoid protocol violations and to limit further exposure to ABT and ABT-related risks.

Iron deficiency and anaemia in bariatric surgical patients: causes, diagnosis and proper management.

Obesity-induced chronic inflammation leads to activation of the immune system that causes alterations of iron homeostasis including hypoferraemia, iron-restricted erythropoiesis, and finally mild-to-moderate anaemia. Thus, preoperative anaemia and iron deficiency are common among obese patients scheduled for bariatric surgery (BS). Assessment of patients should include a complete haematological and biochemical laboratory work-up, including measurement of iron stores, vitamin B12 and folate. In addition, gastrointestinal evaluation is recommended for most patients with iron-deficiency anaemia. On the other hand, BS is a long-lasting inflammatory stimulus in itself and entails a reduction of the gastric capacity and/or exclusion from the gastrointestinal tract which impair nutrients absorption, including dietary iron. Chronic gastrointestinal blood loss and iron-losingenteropathy may also contribute to iron deficiency after BS. Perioperative anaemia has been linked to increased postoperative morbidity and mortality and decreased quality of life after major surgery, whereas treatment of perioperative anaemia, and even haematinic deficiency without anaemia, has been shown to improve patient outcomes and quality of life. However, long-term follow-up data in regard to prevalence, severity, and causes of anaemia after BS are mostly absent. Iron supplements should be administered to patients after BS, but compliance with oral iron is no good. In addition, once iron deficiency has developed, it may prove refractory to oral treatment. In these situations, IV iron (which can circumvent the iron blockade at enterocytes and macrophages) has emerged as a safe and effective alternative for perioperative anaemia management. Monitoring should continue indefinitely even after the initial iron repletion and anaemia resolution, and maintenance IV iron treatment should be provided as required. New IV preparations, such ferric carboxymaltose, are safe, easy to use and up to 1000 mg can be given in a single session, thus providing an excellent tool to avoid or treat iron deficiency in this patient population.

Efficacy and safety of intravenous iron therapy as an alternative/adjunct to allogeneic blood transfusion.

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. In surgical patients, postoperative anaemia is mainly caused by perioperative blood loss, and it might be aggravated by inflammation-induced inhibition of erythropoietin and functional iron deficiency (a condition that cannot be corrected by the administration of oral iron). All these mechanisms may be involved in the anaemia of the critically ill. 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.

Perioperative anaemia management: consensus statement on the role of intravenous iron.

A multidisciplinary panel of physicians was convened by Network for Advancement of Transfusion Alternatives to review the evidence on the efficacy and safety of i.v. iron administration to increase haemoglobin levels and reduce blood transfusion in patients undergoing surgery, and to develop a consensus statement on perioperative use of i.v. iron as a transfusion alternative. After conducting a systematic literature search to identify the relevant studies, critical evaluation of the evidence was performed and recommendations formulated using the Grades of Recommendation Assessment, Development and Evaluation Working Group methodology. Two randomized controlled trials (RCTs) and six observational studies in orthopaedic and cardiac surgery were evaluated. Overall, there was little benefit found for the use of i.v. iron. At best, i.v. iron supplementation was found to reduce the proportion of patients requiring transfusions and the number of transfused units in observational studies in orthopaedic surgery but not in cardiac surgery. The two RCTs had serious limitations and the six observational limited by the selection of the control groups. Thus, the quality of the available evidence is considered moderate to very low. For patients undergoing orthopaedic surgery and expected to develop severe postoperative anaemia, the panel suggests i.v. iron administration during the perioperative period (weak recommendation based on moderate/low-quality evidence). For all other types of surgery, no evidence-based recommendation can be made. The panel recommends that large, prospective, RCTs be undertaken to evaluate the efficacy and safety of i.v. iron administration in surgical patients. The implementation of some general good practice points is suggested.