Abstract

AIM: To identify the effect of enhanced recovery after surgery (ERAS) and rapid rehabilitation concepts on the outcomes of patients with haemophilia A undergoing total knee arthroplasty. DESIGN Randomized controlled trial. METHODS The primary endpoint was postoperative hospital stay. The secondary endpoints were pain scores, joint function scores, haemoglobin levels at 3 and 7 days after surgery and satisfaction with hospitalization. RESULTS Thirty-two patients were enrolled. Compared with the routine nursing group, the ERAS group showed shorter postoperative hospital stay (14.2 SD 0.8 vs. 16.6 ± 1.3 days, p < .001), smaller amounts of blood transfusion (924 SD 317 vs. 1,263 SD 449 ml, p = .020) and coagulation factors (37,325 SD 5,996 vs. 48,475 SD 8,019 U, p < .001), lower pain scores at 3 (3.3 SD 0.7 vs. 4.3 SD 0.7, p = .002) and 7 (2.3 SD 0.7 vs. 2.8 ± 0.5, p = .015) days, lower hospital for special surgery knee scores at 3 (59.9 SD 7.8 vs. 53.6 SD 5.9, p = .016) and 7 (77.9 SD 6.9 vs. 71.1 ± 7.1, p = .009) days and higher satisfaction with hospitalization (94.3 SD 1.4 vs. 92.7 SD 1.6, p = .004).

Abstract

OBJECTIVE To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery. DESIGN A prospective, single-blinded, randomized controlled study. SETTING National Center for Cardiovascular Diseases and a university hospital. PARTICIPANTS The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery. INTERVENTIONS The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group. MEASUREMENTS AND MAIN RESULTS The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p=0.023, p=0.037, and p=0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24hours, postoperative hospital stay >10days, poor wound healing, and perivalvular leakage between the 2 groups. CONCLUSIONS Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.

Abstract

BACKGROUND The efficacy of tranexamic acid (TXA) to reduce perioperative blood loss and allogeneic blood transfusion in cardiac surgeries has been proved in previous studies, but its adverse effects especially seizure has always been a problem of concern. This meta-analysis aims to provide information on the optimal dosage and delivery method which is effective with the least adverse outcomes. METHODS We searched Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE for all relevant articles published before 2018/12/31. Inclusion criteria were adult patients undergoing elective heart surgeries, and only randomized control trials comparing TXA with placebo were considered. Two authors independently assessed trial quality and extracted relevant data. RESULTS We included 49 studies with 10,591 patients into analysis. TXA significantly reduced transfusion rate (RR 0.71, 95% CI 0.65 to 0.78, P<0.00001). The overall transfusion rate was 35%(1573/4477) for patients using TXA and 49%(2190/4408) for patients in the control group. Peri-operative blood loss (MD - 246.98 ml, 95% CI - 287.89 to - 206.06 ml, P<0.00001) and re-operation rate (RR 0.62, 95% CI 0.49 to 0.79, P<0.0001) were also reduced significantly. TXA usage did not increase risk of mortality, myocardial infarction, stroke, pulmonary embolism and renal dysfunction, but was associated with a significantly increase in seizure attack (RR 3.21, 95% CI 1.04 to 9.90, P = 0.04).The overall rate of seizure attack was 0.62%(21/3378) for patients using TXA and 0.15%(5/3406) for patients in the control group. In subgroup analysis, TXA was effective for both on-pump and off-pump surgeries. Topical application didn't reduce the need for transfusion requirement, while intravenous delivery no matter as bolus injection alone or bolus plus continuous infusion were effective. Intravenous high-dose TXA didn't further decrease transfusion rate compared with low-dose regimen, and increased the risk of seizure by 4.83 times. No patients in the low-dose group had seizure attack. CONCLUSIONS TXA was effective in reducing transfusion requirement in all kinds of cardiac surgeries. Low-dose intravenous infusion was the most preferable delivery method which was as effective as high-dose regimen in reducing transfusion rate without increasing the risk of seizure.

Abstract

AIMS: Safety evaluations of tranexamic acid (TXA) remain sparse, especially with respect to its impact on long-term outcomes in patients undergoing on-pump coronary artery bypass grafting (CABG). We hypothesized that the effects of TXA on perioperative bleeding and allogeneic transfusion and its impact on long-term clinical outcomes of patients receiving on-pump CABG are superior to those in the control group. METHODS In this prospective, randomized, placebo-controlled trial, 210 patients undergoing primary and isolated on-pump CABG were randomly assigned to receive TXA or a corresponding volume of saline solution. Randomly assigned patients were followed up at 1, 3, 5, and 7 years after hospital discharge. Finally, 163 patients fulfilled the 7-year follow-up. The primary outcome was allogeneic red blood cell (RBC) transfusion. Long-term mortality and morbidity were also evaluated. RESULTS Compared with placebo, TXA reduced the allogeneic RBC requirement in terms of the volume transfused (4.20+/-4.06 vs. 6.25+/-4.86 units; p<0.01), ratio exposed (52.0% vs. 71.6%; p<0.01), and blood loss volume (879.0+/-392.5 vs. 1154.0+/-582.8 mL; p<0.01). Except for myocardial infarction, there were no significant differences in mortality or morbidity between the two groups during the 7-year follow-up. The TXA group had a lower rate of myocardial infarction than did the placebo group (0.0% vs. 4.9% at 84 months; p=0.03). CONCLUSIONS TXA significantly decreased postoperative bleeding and allogeneic transfusion in patients undergoing on-pump CABG. The 7-year follow-up suggested that the use of TXA was safe and might play a potential role in the prevention of long-term myocardial infarction. This article is protected by copyright. All rights reserved.

Abstract

BACKGROUND Dual antiplatelet therapy is widely used in patients with coronary artery disease and increases the risk of excessive bleeding and transfusion in those undergoing coronary artery bypass grafting (CABG). METHODS The study was a prospective, randomized, double-blinded and placebo-controlled trial. Patients undergoing primary and isolated on-pump CABG with their last dose of clopidogrel and aspirin less than 7 days preoperatively were randomly assigned to receive tranexamic acid (15 mg/kg before surgical incision and 15 mg/kg after protamine neutralization) or a corresponding volume of saline solution. The primary outcome was allogeneic erythrocyte transfusion. RESULTS Randomly assigned participants were 120 adults among whom 117 were analyzed, 58 in the tranexamic acid group and 59 in the placebo group. As compared with placebo, tranexamic acid reduced allogeneic erythrocyte requirement-both the volume transfused (4.84 +/- 5.85 versus 9.36 +/- 11.41 units; mean difference -4.52 units; 95% interval confidence [CI], -7.85 to -1.19 units; p < 0.001) and the ratio exposed (72.4% versus 91.5%; risk difference in percentage point, -19.1; 95% CI, -32.6 to -5.59; relative risk, 0.79; 95% CI, 0.66 to 0.94; p = 0.007)-blood loss (1069.1 +/- 565.5 mL versus 1449.8 +/- 899.8 mL; mean difference, -380.7 mL; 95% CI, -656.4 to -104.9 mL; p = 0.005), major bleeding (50.0% versus 78.0%; risk difference, -28.0; 95% CI, -44.6 to -11.3; relative risk, 0.64; 95% CI, 0.48 to 0.86; p = 0.002), and reoperation (0.0% versus 10.2%; risk difference, -10.2; 95% CI, -17.9 to -2.46; relative risk, 0.08; 95% CI, 0.00 to 1.36; p = 0.01). CONCLUSIONS Tranexamic acid significantly reduced blood loss, major bleeding, reoperation, and allogeneic transfusion in patients undergoing primary and isolated on-pump CABG without clopidogrel and aspirin cessation. Copyright 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Abstract

IMPORTANCE Excessive bleeding and transfusion increase morbidity and mortality in patients receiving coronary artery bypass grafting (CABG), especially in those exposed to antiplatelet agents. OBJECTIVE To evaluate the influence and interaction of clopidogrel bisulfate and tranexamic acid on bleeding and transfusion outcomes. DESIGN A multicenter randomized and blinded trial. SETTING Seven medical centers across China. PARTICIPANTS Patients eligible for randomization were 1173 men and women aged 18 to 85 years undergoing primary and isolated on-pump CABG; 570 adults were randomized and 552 were analyzed. Patients were recruited and stratified into 3 levels according to preoperative clopidogrel exposure (clopidogrel ingestion <=7 days, clopidogrel discontinuation >7 days, and nonexposure). INTERVENTION Patients were randomized to receive tranexamic acid (10-mg/kg-1 bolus and 10-mg/kg-1/h-1 maintenance dose) or placebo. MAIN OUTCOME MEASURE The primary outcomes included blood loss, major bleeding, and red blood cell (RBC) transfusion volume and exposure. RESULTS As compared with controls, clopidogrel increased blood loss (mean difference [MD], 270 mL; 95% CI, 135 to 404 mL), major bleeding (risk difference [RD], 18.5; 95% CI, 7.85 to 29.2), volume of RBCs transfused (MD, 2.97 U; 95% CI, 1.51 to 4.43 U), and RBC transfusion exposure (RD, 17.9; 95% CI, 8.51 to 27.2). As compared with placebo, tranexamic acid reduced blood loss (MD, -278 mL; 95% CI, -380 mL to -176 mL), major bleeding (RD, -19.5; 95% CI, -27.7 to -11.4), volume of RBCs transfused (MD, -2.58 U; 95% CI -3.61 U to -1.55 U), and RBC transfusion exposure (RD, -18.9; 95% CI, -26.4 to -11.4). Subgroup analysis demonstrated a significantly enhanced effect of tranexamic acid especially in patients with impaired platelet function. CONCLUSIONS AND RELEVANCE Preoperative clopidogrel exposure increased bleeding and transfusion requirements in patients receiving on-pump CABG. Tranexamic acid reduced this risk and provided extra protection selectively in the patients with persistent clopidogrel exposure within 7 days before surgery. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01060163.

Abstract

BACKGROUND Bleeding and the need for allogeneic transfusions are still problems after off-pump coronary artery bypass grafting (OPCAB) surgery. We therefore evaluated the effects of an antifibrinolytic, tranexamic acid, on postoperative bleeding and transfusion requirements in patients undergoing OPCAB surgery. METHODS Two hundred thirty-one consecutive patients scheduled for elective OPCAB were enrolled in the study. Using a double-blind method, the patients were randomly assigned to receive either tranexamic acid (bolus 1 g before surgical incision followed by an infusion of 400 mg/h during surgery; n = 116) or a placebo (infusion equivalent volume of saline solution; n = 115). The primary outcome was 24-hour postoperative chest tube drainage. Allogeneic transfusion, mortality, major morbidities, and resource utilization were also recorded. RESULTS In comparison with the placebo group, the patients receiving tranexamic acid had a significant reduction in chest tube drainage at 6 hours (270 +/- 118 mL vs 416 +/- 179 mL, P < 0.001) and 24 hours (654 +/- 224 mL vs 891 +/- 295 mL, P < 0.001). There was also a significant reduction in allogeneic red blood cell transfusions (47 vs 31.9%, P = 0.019) and fresh frozen plasma (29.6% vs 17.2%, P = 0.027) transfusions. There were no differences in mortality, morbidity, and resource utilization between the 2 groups. CONCLUSIONS Tranexamic acid reduces postoperative chest tube drainage and the requirement for allogeneic transfusion in off-pump coronary surgery.

Abstract

Acute preoperative plateletpheresis (APP), cell salvage (CS) technique, and the use of aprotinin have been individually reported to be effective in reducing blood loss and blood component transfusion while improving hematological profiles in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). In this prospective randomized clinical study, the efficacy of these combined approaches on reducing blood loss and transfusion requirements was evaluated. Seventy patients undergoing primary coronary artery bypass grafting (CABG) were randomly divided into four groups: a control group (group I, n = 10) did not receive any of the previously mentioned approaches. An APP and CS group (group II, n = 20) experienced APP in which preoperative platelet-rich plasma was collected and reinfused after reversal of heparin, along with the cell salvage technique throughout surgery. The third group (group III, n = 22) received aprotinin in which 5,000,000 KIU Trasylol was applied during surgery, and a combination group (group IV, n = 18) was treated with all three approaches, i. e. , APP, CS, and aprotinin. Compared with group I (896+/-278 mL), the postoperative total blood loss was significantly reduced in groups II, III, and IV (468+/-136, 388+/-122, 202+/-81 mL, respectively, p < 0. 05). The requirements of packed red blood cells in the three approached groups (153+/-63, 105+/-178, 0+/-0 mL, respectively) also were reduced when compared with group I (343+/-118 mL, p < 0. 05). In group I, six patients (6/10) received fresh-frozen plasma and three patients (3/10) received platelet transfusion, whereas no patients in the other three groups required fresh-frozen plasma and platelet. In conclusion, both plateletpheresis concomitant with cell salvage and aprotinin contribute to the improvement of postoperative hemostasis, and the combination of these two approaches could minimize postoperative blood loss and requirement.