A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
BMC nephrology. 2021;22(1):391
BACKGROUND Erythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage. Biosimilar epoetin is a potential cost-effective alternative to originator for optimal renal anaemia management. OBJECTIVE To determine efficacy and safety of PDA10 in treating renal anaemia in haemodialysis patients, in comparison to the originator epoetin-α, Eprex®. METHODS A phase 3, multicentre, multi-national, double-blind, randomised, active-controlled and parallel group study conducted over 40 weeks in Malaysia and Korea. End stage kidney disease patients undergoing regular haemodialysis who were on erythropoietin treatment were recruited. The study has 3 phases, which included a 12-week titration phase, followed by 28-week double-blind treatment phase and 24-week open-label extension phase. RESULTS The PDA10 and Eprex® were shown to be therapeutically equivalent (p < 0.0001) with mean absolute change in haemoglobin from baseline of - 0.176 (± 0.91) g/dl and - 0.118 (± 1.114) g/dl, respectively. Weekly dose change was 10.01 IU/kg/week in PDA10 group and 10.30 IU/kg/week in Eprex® group, which has no significant difference. There were no significant differences in the safety profile between PDA10 and Eprex® groups. CONCLUSION This study has confirmed the therapeutic equivalence between PDA10 and Eprex® in terms of efficacy, dosage requirement and safety profile in haemodialysis patients with renal anaemia. TRIAL REGISTRATION The study was registered with the National Medical Research Register ( NMRR-13-400-16313 ). This study has been registered retrospectively with Clinical Research Information Service ( CRiS ), Republic of Korea on 25 March 2021.
A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus
Annals of surgical treatment and research. 2021;101(5):299-305
PURPOSE InnoSEAL Plus is an adhesive, coagulant-free hemostatic material that mimics the adhesion mechanism of marine mussels. This study reports on the safety and efficacy of InnoSEAL Plus for patients with hemorrhage after hepatectomy despite first-line hemostasis treatments. METHODS This is a multicenter, prospective, single-blinded, randomized clinical trial involving 96 hepatectomy patients. TachoSil was used as a comparator group. Three-minute and 10-minute hemostatic success rates were monitored. Rebleeding rates were also observed. Safety was assessed by recording all novel undesirable symptoms. RESULTS InnoSEAL Plus showed a 3-minute hemostasis rate of 100%, while TachoSil had a rate of 98.0% (48 of 49 patients), demonstrating that the 2 had similar hemostatic efficacies. The difference in efficacy between the test and comparator group was 2.04%, and the lower limit of the one-sided 97.5% confidence interval was -1.92%; as this is greater than the noninferiority limit of -23.9%, the 2 treatments were equivalent. Meanwhile, the 10-minute hemostatic success rate was the same in both groups (100%). No rebleeding occurred in either group. In the safety evaluation, 89 patients experienced adverse events (45 in the test group and 44 in the comparator group). The difference between the 2 groups was not significant. No death occurred after application of the test or comparator group product. CONCLUSION Given that InnoSEAL Plus is a coagulation factor-free product, the hemostasis results are encouraging, especially considering that TachoSil contains a coagulation factor. InnoSEAL Plus was found to be a safe and effective hemostatic material for control of bleeding in hepatectomy patients.
Dexmedetomidine decreased the post-thyroidectomy bleeding by reducing cough and emergence agitation - a randomized, double-blind, controlled study
BMC anesthesiology. 2021;21(1):113
BACKGROUND Bleeding after thyroidectomy occurs due to violent coughing during emergence. Dexmedetomidine is helpful for the smooth emergence and suppression of cough. The purpose of the present study was to compare the effects of dexmedetomidine on postoperative bleeding after thyroidectomy. METHODS Randomized, double-blind, controlled trials were conducted in female patients (ASA I-II, aged 20 to 60 years). The patients were randomly allocated into two groups. Approximately 15 min before the end of the surgery, dexmedetomidine was administered (0.6 µg/kg/h) without a loading dose in group D (n = 69), and normal saline was administered in group S (n = 70) at the same infusion rate. Hemodynamic data, coughing reflex, extubation time, Ramsay sedation scale (RSS), and recovery time were assessed during the administration of the study drugs and recovery from anesthesia. The amount of postoperative hemorrhage was measured for 3 days. RESULTS Data from a total of 139 patients were analyzed. The incidence of severe cough was significantly lower in group D than in group S (4.3 % vs. 11.5 %, P = 0.022). The emergence agitation in the postanesthetic care unit was significantly lower in group D than in group S (P = 0.01). Postoperative bleeding was significantly lower in group D than in group S until the second postoperative day (P = 0.015). CONCLUSIONS Dexmedetomidine can be helpful in decreasing bleeding after thyroidectomy by reducing coughing and emergence agitation. TRIAL REGISTRATION This study was registered at http://clinicaltrials.gov (registration number NCT02412150, 09/04/2015).
Intra-articular Administration of Tranexamic Acid Has No Effect in Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary ACL Reconstruction Using a Quadruple Hamstring Graft: A Randomized Controlled Trial
Orthop J Sports Med. 2020;8(7):2325967120933135
BACKGROUND Insufficient data are available to support the routine use of tranexamic acid (TXA) in anterior cruciate ligament (ACL) surgeries with respect to administration method and frequency, exposure duration, dose, and adverse effects. PURPOSE To investigate whether intra-articular (IA) administration of TXA could reduce hemarthrosis and postoperative pain in patients after ACL reconstruction. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS A total of 47 patients were included in this study, which was performed between July 2017 and May 2019. Single-bundle reconstructions using autologous hamstring tendon grafts were performed in all patients. The patients were randomized into 2 groups: the TXA group (received the index procedure with 100-mL IA injection of TXA [30 mg/mL]) and a control group (did not receive IA injection of TXA). No patients received a drain. Blood loss was calculated on the basis of hemoglobin balance at postoperative day (PD) 2. The visual analog scale (VAS) for pain score was assessed at PD 3. The midpatellar circumference was measured at PD 2 and PD 5. Knee range of motion (ROM) was evaluated 6 weeks after surgery. RESULTS The mean ± SD blood loss was 467 ± 242 mL in the TXA group and 558 ± 236 mL in the control group. No significant differences were found for blood loss (P = .20), VAS pain scores (P = .28), ROM at postoperative week 6 (P = .61), or patellar circumference at PD 2 (P = .75) and PD 5 (P = .84). CONCLUSION This study showed that IA administration of 3.0 g of TXA had no effect in reducing blood loss and postoperative pain after primary anatomic single-bundle ACL reconstruction using quadruple hamstring autografts. REGISTRATION NCT04042688 (ClinicalTrials.gov identifier).
Deep neuromuscular blockade during spinal surgery reduces intra-operative blood loss: A randomised clinical trial
European journal of anaesthesiology. 2019
BACKGROUND Spinal surgery is usually performed in the prone position using a posterior approach. However, the prone position may cause venous engorgement in the back and thus increase surgical bleeding with interruption of surgery. The prone position also affects cardiac output since large vessels are compressed decreasing venous return to the heart. OBJECTIVE We hypothesised that deep neuromuscular blockade would be associated with less surgical bleeding during spinal surgery in the prone position. DESIGN Prospective, randomised, single-blinded and parallel study. SETTING University teaching hospital. PARTICIPANTS Eighty-eight patients in two groups. INTERVENTIONS Patients were randomly assigned to moderate neuromuscular blockade or deep neuromuscular blockade. In the moderate neuromuscular blockade group, administration of rocuronium was adjusted such that the train-of-four count was one to two. In the deep neuromuscular blockade group, rocuronium administration was adjusted such that the train-of-four count was zero with a posttetanic count 2 or less. MAIN OUTCOME MEASURES The primary outcome was the volume of intra-operative surgical bleeding. The surgeon's satisfaction with operating conditions, haemodynamic and respiratory status, and postoperative pain scores were evaluated. RESULTS The median [IQR] volume of intra-operative surgical bleeding was significantly less in the deep neuromuscular blockade group than in the moderate neuromuscular blockade group; 300 ml [200 to 494] vs. 415 ml [240 to 601]; difference: 117 ml (95% CI, 9 to 244; P = 0.044). The mean +/- SD surgeon's satisfaction with the intra-operative surgical conditions was greater in the deep neuromuscular blockade group than in the moderate neuromuscular blockade group; 3.5 +/- 1.0 vs. 2.9 +/- 0.9 (P = 0.004). In intergroup comparisons of respiratory variables, peak inspiratory pressure was lower in the deep neuromuscular blockade group overall (P < 0.001). The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023). CONCLUSION Deep neuromuscular blockade reduced intra-operative surgical bleeding in patients undergoing spinal surgery. This may be related to greater relaxation in the back muscles and lower intra-operative peak inspiratory pressure when compared with moderate neuromuscular blockade. TRIAL REGISTRATION KCT0001264 (http://cris.nih.go.kr).
Is perioperative colloid infusion more effective than crystalloid in preventing postoperative nausea and vomiting?: A systematic review and meta-analysis
BACKGROUND Adequate intravenous fluid replacement is recommended as an effective nonpharmacologic strategy for reducing postoperative nausea and vomiting (PONV), one of the most common and stressful complications of general anesthesia. We aimed to evaluate the effect of hydration, according to the type of fluid, on PONV as previous studies have reported inconsistent results. METHODS We performed a systemic review and meta-analysis of randomized controlled trials (RCTs) comparing infusion of colloid with that of crystalloid in terms of PONV incidence and the need for rescue antiemetic therapies for 24 hours after surgery under general anesthesia. The effect of fluid infusion according to the duration of anesthesia was also examined. A literature search was performed, using MEDLINE, Excerpta Medica Database, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus, up to February 2018. RESULTS We included 8 RCTs. Compared with the crystalloid infusion, perioperative colloid infusion did not reduce PONV incidence, with a relative risk of 0.87 (95% confidence interval [CI], 0.60-1.25). However, subgroup analysis by duration of anesthesia showed a statistically significant subgroup effect (P = .04, I = 77.4%), suggesting that the effect of colloid differed from that of crystalloid depending on the duration of anesthesia. In the subgroup that underwent anesthesia for more than 3 hours, in which the patients had mostly undergone abdominal surgeries, colloid infusion significantly reduced the incidence of PONV compared with crystalloid infusion (RR, 0.69; 95% CI, 0.53-0.89). In the subgroup that underwent anesthesia for <3 hours, colloid infusion did not reduce the incidence of PONV compared with crystalloid infusion (RR, 1.32; 95% CI, 0.76-2.27). The requirement for antiemetics was comparable between colloid and crystalloid infusions, with an RR of 0.93 (95% CI, 0.55-1.58). CONCLUSION Colloid administration had a more preventive effect on PONV than crystalloid administration in patients undergoing abdominal surgery under general anesthesia for more than 3 hours but did not show a preventive effect in patients undergoing anesthesia for <3 hours.
Administration of intravenous albumin around the time of oocyte retrieval reduces pregnancy rate without preventing ovarian hyperstimulation syndrome: a systematic review and meta-analysis
Gynecologic & Obstetric Investigation. 2010;70((1):):47-54.
BACKGROUND/AIM: The aim of this meta-analysis was to evaluate whether IV albumin infusion around the time of oocyte retrieval prevents ovarian hyperstimulation syndrome (OHSS) and affects the pregnancy rate. METHODS A meta-analysis of data from 9 randomized controlled trials including 1,613 women at high risk for developing OHSS in in vitro fertilization cycles was performed. RESULTS The combined incidence of severe OHSS was 6.0% in the IV albumin group and 7.9% in saline or no treatment groups. These rates were statistically not different (RR = 0.80, 95% CI = 0.57-1.12). Treatment with IV albumin significantly lowered the pregnancy rates (RR = 0.85, 95% CI = 0.74-0.98). CONCLUSIONS The combined data presented in this meta-analysis do not support a benefit for IV albumin around the time of oocyte retrieval in preventing OHSS and even showed a deleterious effect on the pregnancy rate.
Effect of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy
Gynecologic Oncology. 2007;105((1):):199-204.
OBJECTIVE The incidence of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy is estimated to be more than 50%. Transfusion has been the mainstay of hematologic support with its inherent hazards including infection and transfusion reaction. The aim of this study was to examine the impact of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients undergoing concurrent chemoradiotherapy. METHODS From Oct. 2003 to Dec. 2005, 75 patients were treated with platinum-based concurrent chemoradiotherapy. Thirty patients received 200 mg of iron sucrose intravenously (study group) and 45 patients did not receive it (control group). RESULTS In the study group, only 12 (40. 0%) patients required blood transfusions, whereas 29 (64. 0%) patients in the control group needed blood transfusions (P=0. 04). Mean transfusion units were 1. 87 units in the study group and 3. 58 units in the control group (P=0. 04). CONCLUSION This study showed that intravenous supply of iron sucrose could decrease transfusion requirement and increase serum hemoglobin level in patients with cervical carcinoma undergoing concurrent chemoradiotherapy. Therefore, intravenously administered iron sucrose would be effective in the prevention of anemia of cervical cancer patients receiving concurrent chemoradiotherapy.