Background: With the substantially growing trend of the aging populations in China and the rest of the world, the number of total hip and total knee arthroplasty (THA and TKA) cases are increasing dramatically. It’s important to develop practical strategies to improve the quality of healthcare and better outcome for patients undergoing THA and TKA. Enhanced recovery after surgery (ERAS) pathways have been reported to promote earlier recovery and be beneficial for patients. We propose the hypothesis that ERAS pathway could provide better recovery for patients undergoing primary THA or TKA. Methods/Design: This trial is a prospective, open-labelled, randomized controlled trial that will evaluate the length of stay (LOS) in hospital, and other end points of interest for the patients undergoing ERAS pathway as compared to current non-ERAS clinical practice. A total of 640 patients undergoing primary THA or TKA will be randomly allocated to either ERAS pathway (ERAS group) or conventional care according to individual participating center (non-ERAS group). The primary outcome is the total LOS in hospital, the secondary outcomes include Postoperative LOS, all-cause mortality by 30 days after operation, in-hospital complications, early mobilization, postoperative pain control, total in-hospital cost, and readmission rate by 30 days after discharge from the hospital. Discussion: This trial is designed to evaluate the superiority of the ERAS pathway to conventional non-ERAS clinical practice in reducing the LOS without increasing the incidence of complications or medical cost. The results will provide new insight into the clinical applications of ERAS pathway for total hip and total knee arthroplasty. Trial registration: The National Institutes of Health Clinical Trials Registry, NCT03517098. Registered 04, May, 2018. https://register.clinicaltrials.gov/prs/app/action/ SelectProtocol?sid=S0007YV7&selectaction=Edit&uid=U0001B4E&ts=2&cx=97eyz9
Background:Red-cell transfusion is critical for surgery during the peri-operative period; however, the transfusion threshold remains controversial mainly owing to the diversity among patients. The patient's medical status should be evaluated before making a transfusion decision. Herein, we developed an individualized transfusion strategy using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance and designed an open-label, multicenter, randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively, providing valid evidence for peri-operative transfusion.Methods:Patients aged >14 years undergoing elective non-cardiac surgery with estimated blood loss > 1000 mL or 20% blood volume and hemoglobin concentration <10 g/dL were randomly assigned to an individualized strategy, a restrictive strategy following China's guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration <9.5 g/dL. We evaluated two primary outcomes: the proportion of patients who received red blood cells (superiority test) and a composite of in-hospital complications and all-cause mortality by day 30 (non-inferiority test).Results:We enrolled 1182 patients: 379, 419, and 384 received individualized, restrictive, and liberal strategies, respectively. Approximately 30.6% (116/379) of patients in the individualized strategy received a red-cell transfusion, less than 62.5% (262/419) in the restrictive strategy (absolute risk difference, 31.92%; 97.5% confidence interval [CI]: 24.42–39.42%; odds ratio, 3.78%; 97.5% CI: 2.70–5.30%; P<0.001), and 89.8% (345/384) in the liberal strategy (absolute risk difference, 59.24%; 97.5% CI: 52.91–65.57%; odds ratio, 20.06; 97.5% CI: 12.74–31.57; P<0.001). No statistically significant differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies.Conclusion:The individualized red-cell transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries.Trial registration:ClinicalTrials.gov, NCT01597232.
Background: Restrictive blood transfusion is recommended by major guidelines for perioperative management, but requires objective assessment at 7-10 g/dl haemoglobin (Hb). A scoring system that considers the physiological needs of the heart may simply the practice and reduce transfusion.Methods: Patients (14-65 years of age) undergoing non-cardiac surgery were randomised at a 1:1 ratio to a control group versus a Perioperative Transfusion Trigger Score (POTTS) group. POTTS (maximum of 10) was calculated as 6 plus the following: adrenaline infusion rate (0 for no infusion, 1 for ≤0.05 μgÁkg À1 Ámin À1 , and 2 for higher rate), FiO 2 to keep SpO 2 at ≥95% (0 for ≤35%, 1 for 36%-50%, and 2 for higher), core temperature (0 for <38 C, 1 for 38-40 C, and 2 for higher), and angina history (0 for no, 1 for exertional, and 2 for resting). Transfusion is indicated when actual Hb is lower than the calculated POTTS in individual patients. Transfusion in the control group was based on the 2012 American Association for Blood Banks (AABB) guideline. The primary outcome was the proportion of the patients requiring transfusion of allogeneic red blood cells (RBCs) during the perioperative period (until discharge from hospital), as assessed in the intention-to-treat (ITT) population (all randomised subjects).Result: A total of 864 patients (mean age 44.4 years, 244 men and 620 women) were enrolled from December 2017 to January 2021 (433 in the control and 431 in the POTTS group). Baseline Hb was 9.2 ± 1.8 and 9.2 ± 1.7 g/dl in the control and POTTS This study was registered at http://www.chictr.org.cn (#ChiCTR-INR-17014085).
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