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Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia
Friedman, T., Dann, E. J., Bitton-Worms, K., Makhoul, M., Glam, R., Weis, A., Tam, D. Y., Bolotin, G.
British journal of anaesthesia. 2023
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Editor's Choice
Abstract
BACKGROUND Reducing the need for blood transfusion among patients undergoing cardiac surgery FLA reduce postoperative complications and mortality. Our study aimed to assess the effects of administering preoperative i.v. ferric carboxymaltose on postoperative red cell transfusion requirements in patients without anaemia undergoing on-pump cardiac surgery. METHODS This double-blind, randomised, placebo-controlled trial was conducted between October 2016 and November 2019, with a follow-up period of up to 6 weeks after surgery. Patients without anaemia who underwent on-pump cardiac surgery were included as participants and administered i.v. iron in the form of ferric carboxymaltose or placebo once, 24-72 h before surgery. The primary outcome was the number of red cell units transfused during the first four postoperative days, and the secondary outcome measures were blood haemoglobin concentrations at 4 days and 6 weeks after surgery. RESULTS The 200 patients included were randomly assigned to the ferric carboxymaltose (n=102) and placebo (n=98) groups. By postoperative Day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs 1.6 (4.4), respectively; P=0.007. The mean haemoglobin concentrations on postoperative Day 4 were 9.7 (1) g dl(-1) and 9.3 (1) g dl(-1), respectively (P=0.03). Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl(-1) and 11.8 (1.5) g dl(-1), respectively (P=0.012). CONCLUSIONS In patients without anaemia undergoing on-pump cardiac surgery, treatment with a single dose of 1000 mg ferric carboxymaltose i.v. 1-3 days before surgery significantly reduced the need for red cell transfusions and increased the postoperative haemoglobin concentration. CLINICAL TRIAL REGISTRATION NCT02939794.
PICO Summary
Population
Patients without anaemia who underwent on-pump cardiac surgery (n= 200).
Intervention
Ferric carboxymaltose (n= 102).
Comparison
Placebo (n= 98).
Outcome
By postoperative day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs. 1.6 (4.4), respectively. The mean haemoglobin concentrations on postoperative day 4 were 9.7 (1) g dl(-1) and 9.3 (1) g dl(-1), respectively. Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl(-1) and 11.8 (1.5) g dl(-1), respectively.
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Effect of red blood cell storage time in pediatric cardiac surgery patients: A subgroup analysis of a randomized controlled trial
Martin, S. M., Tucci, M., Spinella, P. C., Ducruet, T., Fergusson, D. A., Freed, D. H., Lacroix, J., Poirier, N., Sivarajan, V. B., Steiner, M. E., et al
JTCVS open. 2023;15:454-467
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Editor's Choice
Abstract
OBJECTIVE This study aimed to determine whether or not transfusion of fresh red blood cells (RBCs) reduced the incidence of new or progressive multiple organ dysfunction syndrome compared with standard-issue RBCs in pediatric patients undergoing cardiac surgery. METHODS Preplanned secondary analysis of the Age of Blood in Children in Pediatric Intensive Care Unit study, an international randomized controlled trial. This study included children enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial and admitted to a pediatric intensive care unit after cardiac surgery with cardiopulmonary bypass. Patients were randomized to receive either fresh (stored ≤7 days) or standard-issue RBCs. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days postrandomization or at pediatric intensive care unit discharge, or death. RESULTS One hundred seventy-eight patients (median age, 0.6 years; interquartile range, 0.3-2.6 years) were included with 89 patients randomized to the fresh RBCs group (median length of storage, 5 days; interquartile range, 4-6 days) and 89 to the standard-issue RBCs group (median length of storage, 18 days; interquartile range, 13-22 days). There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12 (95% CI, 0.81 to 1.54; P = .49) and an unadjusted absolute risk difference of 5.1% (95% CI, -9.5% to 19.8%; P = .49). CONCLUSIONS In neonates and children undergoing cardiac surgery with cardiopulmonary bypass, the use of fresh RBCs did not reduce the incidence of new or progressive multiple organ dysfunction syndrome compared with the standard-issue RBCs. A larger trial is needed to confirm these results.
PICO Summary
Population
Children admitted to a paediatric intensive care unit after cardiac surgery with cardiopulmonary bypass, enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial (ABC-PICU), (n= 178).
Intervention
Fresh (stored ≤7 days) red blood cells (RBCs), (n= 89).
Comparison
Standard-issue RBCs (n= 89).
Outcome
The authors performed a preplanned subgroup analysis of the ABC-PICU trial. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days post-randomization or at paediatric intensive care unit discharge, or death. There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12; 95% CI [0.81, 1.54] and an unadjusted absolute risk difference of 5.1%; 95% CI [-9.5%, 19.8%].
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Health-related quality of life after restrictive versus liberal RBC transfusion for cardiac surgery: Sub-study from a randomized clinical trial
Hu RT, Royse AG, Royse C, Scott DA, Bowyer A, Boggett S, Summers P, Mazer CD
Transfusion. 2022
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Editor's Choice
Abstract
BACKGROUND Transfusion Requirements in Cardiac Surgery III (TRICS III), a multi-center randomized controlled trial, demonstrated clinical non-inferiority for restrictive versus liberal RBC transfusion for patients undergoing cardiac surgery. However, it is uncertain if transfusion strategy affects long-term health-related quality of life (HRQOL). STUDY DESIGN AND METHODS In this planned sub-study of Australian patients in TRICS III, we sought to determine the non-inferiority of restrictive versus liberal transfusion strategy on long-term HRQOL and to describe clinical outcomes 24 months postoperatively. The restrictive strategy involved transfusing RBCs when hemoglobin was <7.5 g/dl; the transfusion triggers in the liberal group were: <9.5 g/L intraoperatively, <9.5 g/L in intensive care, or <8.5 g/dl on the ward. HRQOL assessments were performed using the 36-item short form survey version 2 (SF-36v2). Primary outcome was non-inferiority of summary measures of SF-36v2 at 12 months, (non-inferiority margin: -0.25 effect size; restrictive minus liberal scores). Secondary outcomes included non-inferiority of HRQOL at 18 and 24 months. RESULTS Six hundred seventeen Australian patients received allocated randomization; HRQOL data were available for 208/311 in restrictive and 217/306 in liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery. DISCUSSION The non-inferiority of a restrictive compared to a liberal transfusion strategy was not established for long-term HRQOL in this dataset.
PICO Summary
Population
Patients undergoing cardiac surgery, enrolled in the Australian cohort of the randomised controlled trial: Transfusion Requirements in Cardiac Surgery III (TRICS III), (n= 617).
Intervention
Restrictive transfusion strategy (n= 311).
Comparison
Liberal transfusion strategy (n= 306).
Outcome
Health-related quality of life (HRQOL) data were available for 208 (67%) patients in the restrictive and 217 (71%) patients in the liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery.
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Benefits of pre-operative oral Sucrosomial(®) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender
Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L
Blood transfusion = Trasfusione del sangue. 2022
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Editor's Choice
Abstract
BACKGROUND The prevalence of low pre-operative hemoglobin (Hb) among cardiac surgery patients is high. As iron homeostasis is often impaired in these patients, restoration of iron availability might over-ride iron-restricted erythropoiesis. This post-hoc analysis of a previously published, large, randomized clinical trial (ClincalTrials.gov NCT03560687; n=1,000) assesses which sub-cohort of patients benefits the most from pre-operative Hb optimization with oral Sucrosomial(®) iron. MATERIALS AND METHODS Patients without baseline Hb (n=349) or receiving >5 red blood cell units (n=57) were excluded from the study. Data from the remaining 594 were reanalyzed according to treatment, baseline anemia (Hb <13 g/dL) or gender. Patients (pt) received a one-month course of 60 mg/day Sucrosomial(®) iron (Iron group, n=309) or routine care (Control group, n=285) prior to elective cardiac surgery. Main end-point variables were increase in Hb from randomization to hospital admission, transfusion requirements, and cost-effectiveness of Sucrosomial(®) iron administration. RESULTS At hospital admission, Hb had increased 0.7 g/dL and 0.1 g/dL, for Iron and Control groups, respectively (p<0.001), with no gender-related differences, leading to a decrease in transfusion rate (30 vs 59%, respectively; p<0.001) and transfusion index (0.5 units/patient vs 1.2 units/pt, respectively; p<0.001). Sucrosomial(®) iron administration was well-tolerated, and yielded cost-savings of €92/pt (p<0.001), particularly in those presenting with baseline Hb <13 g/dL. CONCLUSIONS This post-hoc analysis confirms pre-operative Sucrosomial(®) iron administration is a safe and cost-effective strategy to increase preoperative Hb and decrease transfusion requirements in elective cardiac surgery, especially in those anemic at baseline.
PICO Summary
Population
Cardiac surgery patients (n= 594).
Intervention
Sucrosomial® iron prior to elective cardiac surgery (Iron group, n= 309).
Comparison
Routine care (Control group, n= 285).
Outcome
This post-hoc analysis of a large, randomized clinical trial (n= 1,000) reanalyzed data according to treatment, baseline anemia (Hb <13 g/dL) or gender. At hospital admission, haemoglobin (Hb) had increased 0.7 g/dL and 0.1 g/dL, for Iron and Control groups, respectively, with no gender-related differences, leading to a decrease in transfusion rate (30 vs. 59%, respectively) and transfusion index (0.5 units/patient vs. 1.2 units/pt, respectively). Sucrosomial® iron administration was well-tolerated, and yielded cost-savings of €92/pt, particularly in those presenting with baseline Hb <13 g/dL.
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Autologous red blood cell transfusion does not result in a more profound increase in pulmonary capillary wedge pressure compared to saline in critically ill patients: A randomized crossover trial
Bosboom JJ, Klanderman RB, Terwindt LE, Bulle EB, Wijnberge M, Eberl S, Driessen AH, Winkelman TA, Geerts BF, Veelo DP, et al
Vox sanguinis. 2022
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Editor's Choice
Abstract
BACKGROUND AND OBJECTIVES Transfusion-associated circulatory overload (TACO) is a major cause of severe transfusion-related morbidity. Transfusion of red blood cells (RBCs) has been shown to induce hydrostatic pressure overload. It is unclear which product-specific factors contribute. We set out to determine the effect of autologous RBC transfusion versus saline on pulmonary capillary wedge pressure (PCWP) change. MATERIALS AND METHODS In a randomized crossover trial, patients who had undergone coronary bypass surgery were allocated to treatment post-operatively in the intensive care unit with either an initial 300 ml autologous RBC transfusion (salvaged during surgery) or 300 ml saline infusion first, followed by the other. Primary outcome was the difference in PCWP change. Secondary outcome measures were the difference in extra-vascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI). RESULTS Change in PCWP was not higher after autologous RBC transfusion compared to saline (ΔPCWP 0.3 ± 0.4 vs. 0.1 ± 0.4 mmHg). ΔEVLWI and ΔPVPI were significantly decreased after autologous RBC transfusion compared to saline (ΔEVLWI -1.6 ± 0.6 vs. 0.2 ± 0.4, p = 0.02; ΔPVPI -0.3 ± 0.1 vs. 0.0 ± 0.1, p = 0.01). Haemodynamic variables and colloid osmotic pressure were not different for autologous RBC transfusion versus saline. CONCLUSION Transfusion of autologous RBCs did not result in a more profound increase in PCWP compared to saline. RBC transfusion resulted in a decrease of EVLWI and PVPI compared to saline. Our data suggest that transfusing autologous RBCs may lead to less pulmonary oedema compared to saline. Future studies with allogeneic RBCs are needed to investigate other factors that may mediate the increase of PCWP, resulting in TACO.
PICO Summary
Population
Patients undergoing coronary bypass surgery (n= 16).
Intervention
Autologous red blood cells (RBCs) transfusion, with a subsequent infusion of saline (RBCs: Saline, n= 8).
Comparison
Saline infusion with a subsequent transfusion of RBCs (Saline: RBCs, n= 8).
Outcome
The primary outcome was the difference in pulmonary capillary wedge pressure (PCWP) before and after transfusion (ΔPCWP). Secondary outcome measures were the difference in extra-vascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI). Change in PCWP was not higher after autologous RBCs transfusion compared to saline (ΔPCWP 0.3 ± 0.4 vs. 0.1 ± 0.4 mmHg). ΔEVLWI and ΔPVPI were significantly decreased after autologous RBCs transfusion compared to saline (ΔEVLWI -1.6 ± 0.6 vs. 0.2 ± 0.4; ΔPVPI -0.3 ± 0.1 vs. 0.0 ± 0.1). Haemodynamic variables and colloid osmotic pressure were not different for autologous RBCs transfusion versus saline.
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Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial
Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, et al
British journal of anaesthesia. 2021
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Abstract
BACKGROUND Current practice guidelines for red blood cell (RBC) transfusion in ICUs are based on haemoglobin threshold, without consideration of oxygen delivery or consumption. We aimed to evaluate an individual physiological threshold-guided by central venous oxygen saturation ScvO(2). METHODS In a randomised study in two French academic hospitals, 164 patients who were admitted to ICU after cardiac surgery with postoperative haemoglobin <9 g dl(-1) were randomised to receive a transfusion with one unit of RBCs (haemoglobin group) or transfusion only if the ScvO(2) was <70% (individualised group). The primary outcome was the number of subjects receiving at least one unit of RBCs. The secondary composite outcome was acute kidney injury, stroke, myocardial infarction, acute heart failure, mesenteric ischaemia, or in-hospital mortality. One- and 6-month mortality were evaluated during follow-up. RESULTS The primary outcome was observed for 80 of 80 subjects (100%) in the haemoglobin group and in 61 of 77 patients (79%) in the individualised group (absolute risk -21% [-32.0; -14.0]; P<0.001). There was no significant difference in the secondary outcome between the two groups. Follow-up showed a non-significant difference in mortality at 1 and 6 months. CONCLUSIONS An individualised strategy based on an central venous oxygen saturation threshold of 70% allows for a more restrictive red blood cell transfusion strategy with no incidence on postoperative morbidity or 6-month mortality. CLINICAL TRIAL REGISTRATION NCT02963883.
PICO Summary
Population
Patients admitted to intensive care unit after cardiac surgery (n= 164).
Intervention
Transfusion with one unit of red blood cells (RBCs), (haemoglobin group), (n= 82).
Comparison
Transfusion only if the ScvO(2) was <70% (individualised group), (n= 82).
Outcome
The number of patients receiving at least one unit of RBCs was observed for 80 of 80 subjects (100%) in the haemoglobin group and in 61 of 77 patients (79%) in the individualised group. There was no significant difference in the secondary outcome between the two groups. Follow-up showed a non-significant difference in mortality at 1 and 6 months.
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A pilot randomized clinical trial of cryopreserved versus liquid-stored platelet transfusion for bleeding in cardiac surgery: The cryopreserved versus liquid platelet-New Zealand pilot trial
McGuinness S, Charlewood R, Gilder E, Parke R, Hayes K, Morley S, Al-Ibousi A, Deans R, Howe B, Johnson L, et al
Vox sanguinis. 2021
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Editor's Choice
Abstract
BACKGROUND AND OBJECTIVES Platelets for transfusion have a shelf-life of 7 days, limiting availability and leading to wastage. Cryopreservation at -80°C extends shelf-life to at least 1 year, but safety and effectiveness are uncertain. MATERIALS AND METHODS This single centre blinded pilot trial enrolled adult cardiac surgery patients who were at high risk of platelet transfusion. If treating clinicians determined platelet transfusion was required, up to three units of either cryopreserved or liquid-stored platelets intraoperatively or during intensive care unit admission were administered. The primary outcome was protocol safety and feasibility. RESULTS Over 13 months, 89 patients were randomized, 23 (25.8%) of whom received a platelet transfusion. There were no differences in median blood loss up to 48 h between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 10(3) /μl vs. 157 × 10(3) /μl, median difference 39.5 ×10(3) /μl, p = 0.03). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24-h blood loss, red cell transfusion or a composite bleeding outcome. CONCLUSION This pilot randomized controlled trial demonstrated the feasibility of the protocol and adds to accumulating data supporting the safety of this intervention. Given the clear advantage of prolonged shelf-life, particularly for regional hospitals in New Zealand, a definitive non-inferiority phase III trial is warranted.
PICO Summary
Population
Adult cardiac surgery patients who were at high risk of platelet transfusion, enrolled in the CLIP-NZ Pilot study (n= 89).
Intervention
Cryopreserved platelet transfusion (n= 49).
Comparison
Liquid-stored platelet transfusion (n= 40).
Outcome
The primary outcome was protocol safety and feasibility. Over 13 months, 89 patients were randomized, 23 (25.8%) of whom received a platelet transfusion. There were no differences in median blood loss up to 48 hours between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 10(3) /μl vs. 157 × 10(3) /μl, median difference 39.5 ×10(3) /μl). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24 hours blood loss, red cell transfusion or a composite bleeding outcome.
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Restrictive versus Liberal Transfusion in Patients with Diabetes Undergoing Cardiac Surgery: An Open-Label Randomized, Blinded Outcome Evaluation Trial
Mistry N, Shehata N, Carmona P, Bolliger D, Hu R, Carrier FM, Alphonsus CS, Tseng EE, Royse AG, Royse C, et al
Diabetes, obesity & metabolism. 2021
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Editor's Choice
Abstract
AIM: To characterize the association between diabetes and transfusion and clinical outcomes in cardiac surgery, and to evaluate whether restrictive transfusion thresholds are harmful in these patients. MATERIALS AND METHODS The multinational, open-label, randomized controlled TRICS-III trial assessed a restrictive transfusion strategy (hemoglobin [Hb] transfusion threshold <75 g/L) compared to a liberal strategy (Hb <95 g/L for operating room or ICU; or < 85 g/L for ward) in patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death (EuroSCORE ≥6). Diabetes status was collected preoperatively. The primary composite outcome was all-cause death, stroke, myocardial infarction, and new-onset renal failure requiring dialysis at 6 months. Secondary outcomes included components of the composite outcome at 6 months, and transfusion and clinical outcomes at 28 days. RESULTS Of the 5092 patients analyzed, 1396 (27.4%) had diabetes (Restrictive: n = 679, Liberal n = 717). Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes (OR [95%CI]1.10[0.93-1.31]) or the restrictive strategy increased the risk for the primary composite outcome (diabetes OR [95%CI]1.04[0.68-1.59] vs. no diabetes OR 1.02[0.85-1.22],p(interaction) = 0.92). In patients with versus without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion (diabetes OR [95%CI] 0.28[0.21-0.36]; no diabetes OR [95%CI] 0.40[0.35-0.47];p(interaction) = 0.04). CONCLUSIONS The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion. Restrictive transfusion triggers are safe and effective in patients with diabetes undergoing cardiac surgery. This article is protected by copyright. All rights reserved.
PICO Summary
Population
Patients with diabetes undergoing cardiac surgery enrolled in the multinational TRICS-III trial (n= 1,396).
Intervention
Restrictive transfusion threshold strategy (n= 679).
Comparison
Liberal transfusion threshold strategy (n= 717).
Outcome
Of the 5,092 patients analysed, 1396 (27.4%) had diabetes. Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes nor the restrictive strategy increased the risk for the primary composite outcome vs. no diabetes. In patients with vs. without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion.
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Efficacy of quadruple treatment on different types of pre-operative anaemia: secondary analysis of a randomised controlled trial
Rossler J, Hegemann I, Schoenrath F, Seifert B, Kaserer A, Spahn GH, Falk V, Spahn DR
Anaesthesia. 2020
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Editor's Choice
Abstract
In patients with pre-operative anaemia undergoing cardiac surgery, combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12 and oral folic acid reduces allogeneic blood product transfusions. It is unclear if certain types of anaemia particularly benefit from this treatment. We performed a post-hoc analysis of anaemic patients from a randomised trial on the 'Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery'. We used linear regression analyses to examine the efficacy of a combination anaemia treatment compared with placebo on the following deficiencies, each representing a part of the combination treatment: ferritin and transferrin saturation; endogenous erythropoietin; holotranscobalamine; and folic acid in erythrocytes. Efficacy was defined as change in reticulocyte count from baseline to the first, third and fifth postoperative days and represented erythropoietic activity in the immediate peri-operative recovery phase. In all 253 anaemic patients, iron deficiency was the most common cause of anaemia. Treatment significantly increased reticulocyte count in all regression analyses on postoperative days 1, 3 and 5 (all p < 0.001). Baseline ferritin and endogenous erythropoietin were negatively associated with change in reticulocyte count on postoperative day 5, with an unstandardised regression coefficient B of -0.08 (95%CI -0.14 to -0.02) and -0.14 (95%CI -0.23 to -0.06), respectively. Quadruple anaemia treatment was effective regardless of the cause of anaemia and its effect manifested early in the peri-operative recovery phase. The more pronounced a deficiency was, the stronger the subsequent boost to erythropoiesis may have been.
PICO Summary
Population
Patients with iron deficiency or anaemia undergoing cardiac surgery (n=253).
Intervention
Combination anaemia treatment (n=122).
Comparison
Placebo (n=122).
Outcome
Treatment significantly increased reticulocyte count in all regression analyses on postoperative days 1, 3 and 5. Baseline ferritin and endogenous erythropoietin were negatively associated with change in reticulocyte count on postoperative day 5, with an unstandardised regression coefficient B of -0.08 and -0.14, respectively. Quadruple anaemia treatment was effective regardless of the cause of anaemia and its effect manifested early in the peri-operative recovery phase.
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Comparison of effectiveness of tranexamic acid and epsilon-amino-caproic-acid in decreasing postoperative bleeding in off-pump CABG surgeries: A prospective, randomized, double-blind study
Verma S, Srinivas U, Sathpathy AK, Mittal P
Annals of cardiac anaesthesia. 2020;23(1):65-69
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Editor's Choice
Abstract
Context: Off-pump coronary artery bypass graft (CABG) surgeries have been shown to have increased fibrinolysis due to tissue plasminogen activator release. There are no trials comparing the two available antifibrinolytics (tranexemic acid and epsilon-amino-caproic acid) in off-pump CABG surgeries. Aims: The aim of the present study was to compare the effectiveness of tranexamic acid and epsilon-amino-caproic acid with respect to postoperative bleeding at 4 and 24 hours as the primary outcome, and rate of postoperative transfusion, re-operations, complication rate, serum fibrinogen, and D-dimer levels as secondary outcomes. Settings and Design: The study was carried out at a tertiary-level hospital between June 2017 and June 2018. It was a prospective, randomized, double-blind study. Materials and Methods: Eighty patients undergoing off-pump CABG, were randomly allocated to receive tranexamic acid or epsilon-amino-caproic acid. The patients were followed up in the postoperative period and were assessed for primary and secondary outcomes. Statistical Analysis Used: Statistical analysis was performed using SPSS software, version 19.0 (SPSS Inc., Chicago, IL). Nonparametric data were expressed as median with interquartile range and compared using Mann-Whitney U-test, parametric data was represented as mean with standard deviation and analyzed using Student's t-test. Nominal data were analyzed using Chi-square test. Results: Bleeding at 4 hours did not show significant difference between groups, 180 ml (80-250) vs 200 ml (100-310). Bleeding at 24 hours was significantly lesser in tranexamic acid group as compared to epsilon-amino-caproic acid group, 350 ml (130-520) vs 430 ml (160-730) (P = 0.0022) The rate of transfusion, re-operations, seizures, renal dysfunction, fibrinogen levels, and D-dimer levels did not show significant difference between the groups. Conclusions: Tranexamic acid significantly reduced postoperative bleeding in off-pump CABG at 24 hours as compared to epsilon-amino-caproic-acid.
PICO Summary
Population
Patients undergoing off-pump CABG, (n=76).
Intervention
Tranexamic acid, (n=38).
Comparison
Epsilon-amino-caproic acid, (n=38).
Outcome
Bleeding at 4 hours did not show significant difference between groups, 180 ml (80-250) vs 200 ml (100-310). Bleeding at 24 hours was significantly lesser in tranexamic acid group as compared to epsilon-amino-caproic acid group, 350 ml (130-520) vs 430 ml (160-730). The rate of transfusion, re-operations, seizures, renal dysfunction, fibrinogen levels, and D-dimer levels did not show significant difference between the groups.