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.

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.

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.

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.

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.