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Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients
Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J
Scientific reports. 2023;13(1):7682
Abstract
De novo donor-specific antibody (dnDSA) is associated with a higher risk of kidney graft failure. However, it is unknown whether preemptive treatment of subclinical dnDSA is beneficial. Here, we assessed the efficacy of high-dose intravenous immunoglobulin (IVIG) and rituximab combination therapy for subclinical dnDSA. An open-label randomized controlled clinical trial was conducted at two Korean institutions. Adult (aged ≥ 19 years) kidney transplant patients with subclinical class II dnDSA (mean fluorescence intensity ≥ 1000) were enrolled. Eligible participants were randomly assigned to receive rituximab or rituximab with IVIG at a 1:1 ratio. The primary endpoint was the change in dnDSA titer at 3 and 12 months after treatment. A total of 46 patients (24 for rituximab and 22 for rituximab with IVIG) were included in the analysis. The mean baseline estimated glomerular filtration rate was 66.7 ± 16.3 mL/min/1.73 m(2). The titer decline of immune-dominant dnDSA at 12 months in both the preemptive groups was significant. However, there was no difference between the two groups at 12 months. Either kidney allograft function or proteinuria did not differ between the two groups. No antibody-mediated rejection occurred in either group. Preemptive treatment with high-dose IVIG combined with rituximab did not show a better dnDSA reduction compared with rituximab alone.Trial registration: IVIG/Rituximab versus Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies (ClinicalTrials.gov Identifier: NCT04033276, first trial registration (26/07/2019).
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2.
Efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: A multicenter, randomized controlled clinical trial
Choi JH, Cho IR, Lee SH, Kim JS, Park N, Lee MW, Jang DK, Paik WH, Ahn DW, Ryu JK, et al
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2023
Abstract
BACKGROUND Endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (EST) or endoscopic papillectomy (EP). AIMS In this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-EST or post-EP bleeding. METHODS A randomized trial was conducted from November 2020 to December 2021 at two tertiary centers in South Korea. Patients who experienced bleeding immediately after EST or EP were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray. RESULTS A total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group. Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs. 85.4%; P = 0.026). ). In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs. 7.3%; P = 0.329). The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ± 1.94 vs. 1.76 ± 0.99 min; P < 0.001), and no differences were observed in the adverse events. CONCLUSIONS The novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after EST or EP. (Registered in Clinical Research Information Service: KCT0005607).
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3.
The effect of fibrin glue on the quantity of drainage after thyroidectomy: a randomized controlled pilot trial
Ha EJ, Lee J
Annals of surgical treatment and research. 2022;102(4):177-184
Abstract
PURPOSE A seroma is a collection of exudates after surgical trauma in wound healing. Fibrin glue is used to prevent seroma by reducing the generation of exudate. However, the impact of fibrin glue on the prevention of seroma remains debatable. Therefore, we conducted a randomized controlled pilot trial to investigate the effect of the amount of fibrin glue used on the generation of exudate after thyroidectomy and the sample size of future definitive trials. METHODS Between February and December 2020, 41 patients were enrolled; 21 patients in the low fibrin group and 20 in the high fibrin group. Stratified randomization was performed based on sex, body mass index, and thyroiditis. All patients underwent total thyroidectomy and bilateral central compartment dissection. In the low and high fibrin groups, 2 mL and 6 mL of fibrin glue were applied to patients, respectively. RESULTS Both the total drain volume and flow rate during the first 12 hours were lower in the high fibrin group than in the low fibrin group (65.0 mL vs. 47.6 mL, P = 0.008 and 2.7 mL/hr vs. 1.8 mL/hr, P = 0.002, respectively). The calculated sample size for future randomized controlled trial was 32 patients (α = 0.05, power = 0.8), and the power of this trial was 0.91 with µ(1) = 2.7, µ(2) = 1.8, σ = 0.9, and α = 0.05 (µ = mean, σ = standard deviation). CONCLUSION Six milliliters of fibrin glue could reduce total drain volume and flow rate of exudate after thyroidectomy. Therefore, applying an appropriate amount of fibrin glue after thyroidectomy may reduce postoperative seroma.
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4.
Comparison of a Hemostatic Powder and Standard Treatment in the Control of Active Bleeding From Upper Nonvariceal Lesions : A Multicenter, Noninferiority, Randomized Trial
Lau JYW, Pittayanon R, Kwek A, Tang RS, Chan H, Rerknimitr R, Lee J, Ang TL, Suen BY, Yu YY, et al
Annals of internal medicine. 2021
Abstract
BACKGROUND The effectiveness of the hemostatic powder TC-325 as a single endoscopic treatment for acute nonvariceal upper gastrointestinal bleeding is uncertain. OBJECTIVE To compare TC-325 with standard endoscopic hemostatic treatments in the control of active bleeding from nonvariceal upper gastrointestinal causes. DESIGN One-sided, noninferiority, randomized, controlled trial. (ClinicalTrials.gov: NCT02534571). SETTING University teaching hospitals in the Asia-Pacific region. PATIENTS 224 adult patients with acute bleeding from a nonvariceal cause on upper gastrointestinal endoscopy. INTERVENTION TC-325 (n = 111) or standard hemostatic treatment (n = 113). MEASUREMENTS The primary outcome was control of bleeding within 30 days. Other outcomes included failure to control bleeding during index endoscopy, recurrent bleeding after initial hemostasis, further interventions, blood transfusion, hospitalization, and death. RESULTS 224 patients were enrolled (136 with gastroduodenal ulcers [60.7%], 33 with tumors [14.7%], and 55 with other causes of bleeding [24.6%]). Bleeding was controlled within 30 days in 100 of 111 patients (90.1%) in the TC-325 group and 92 of 113 (81.4%) in the standard treatment group (risk difference, 8.7 percentage points [1-sided 95% CI, 0.95 percentage point]). There were fewer failures of hemostasis during index endoscopy with TC-325 (3 [2.7%] vs. 11 [9.7%]; odds ratio, 0.26 [CI, 0.07 to 0.95]). Recurrent bleeding within 30 days did not differ between groups (9 [8.1%] vs. 10 [8.8%]). The need for further interventions also did not differ between groups (further endoscopic treatment: 8 [7.2%] vs. 10 [8.8%]; angiography: 2 [1.8%] vs. 4 [3.5%]; surgery: 1 [0.9%] vs. 0). There were 14 deaths in each group (12.6% vs. 12.4%). LIMITATION Clinicians were not blinded to treatment. CONCLUSION TC-325 is not inferior to standard treatment in the endoscopic control of bleeding from nonvariceal upper gastrointestinal causes. PRIMARY FUNDING SOURCE General Research Fund to the University Grants Committee, Hong Kong SAR Government.
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Impact of Dexmedetomidine on Tourniquet-Induced Systemic Effects in Total Knee Arthroplasty under Spinal Anesthesia: a Prospective Randomized, Double-Blinded Study
Lee C, Lee C, So C, Lee J, Choi I, Ma X, Hwang J
BioMed research international. 2020;2020:4208597
Abstract
BACKGROUND Clinical studies on the impact of dexmedetomidine on tourniquet-induced systemic effects have been inconsistent. We investigated the impact of dexmedetomidine on tourniquet-induced systemic effects in total knee arthroplasty. METHODS Eighty patients were randomly assigned to either control (CON) or dexmedetomidine (DEX) group. The DEX group received an intravenous loading dose of 0.5 μg/kg DEX over 10 minutes, followed by a continuous infusion of 0.5 μg/kg/h from 10 minutes before the start of surgery until completion. The CON group received the same calculated volume of normal saline. Pain outcomes and metabolic and coagulative changes after tourniquet application and after tourniquet release were investigated. RESULTS The frequency of fentanyl administration postoperatively, patient-controlled analgesia (PCA) volume at 24 hours postoperatively, total PCA volume consumed in 48 hours postoperatively, and VAS score for pain at 24 and 48 hours postoperatively were significantly lower in the DEX group than in the CON group. Ten minutes after the tourniquet release, the DEX group showed significantly higher pH and lower lactate level than those in the CON group. Antithrombin III activity and body temperature 10 minutes after tourniquet release were significantly lower in the DEX group than in the CON group. Ca(2+), K(+), HCO(3) (-), base excess, and PCO(2) levels 10 minutes after tourniquet release were not significantly different between the two groups. CONCLUSION We showed that DEX attenuated pain and hemodynamic, metabolic, and coagulative effects induced by the tourniquet. However, these metabolic and coagulative changes were within normal limits. Therefore, DEX could be used as an analgesic adjuvant, but should not be considered for routine use to prevent the systemic effects induced by tourniquet use.
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Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline
Scott A, LaPrade RF, Harmon KG, Filardo G, Kon E, Della Villa S, Bahr R, Moksnes H, Torgalsen T, Lee J, et al
The American journal of sports medicine. 2019;:363546519837954
Abstract
BACKGROUND A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. PURPOSE/HYPOTHESIS To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures-Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change-were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients' global rating of change. RESULTS Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P-58 (29), 71 (20), and 80 (18); pain-4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change-4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). CONCLUSION Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. REGISTRATION NCT02116946 (ClinicalTrials.gov identifier).
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Placebo-controlled, randomized, phase I/II trial of the thrombopoietin receptor agonist eltrombopag in thrombocytopenic patients with advanced myelodysplastic syndromes or acute myeloid leukemia
Platzbecker U, Wong R, Verma A, Abboud C, Araujo S, Chiou T, Feigert J, Yeh S, G÷tze K, Gorin N, et al
Haematologica. 2013;98((S1):):455.. Abstract No. S1108.
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8.
A prospective trial assessing the safety and efficacy of collecting up to 840 mL of plasma in conjunction with saline infusion during plasmapheresis
Buzza M, Marks DC, Capper H, Cassin E, Badcock CA, Reid S, Kwok M, Yang H, Lee J, Corrigan C, et al
Transfusion. 2012;52((8):):1806-13.
Abstract
BACKGROUND The demand for plasma for manufacturing intravenous immunoglobulin and other plasma derivatives is increasing. A prospective study was conducted to determine whether up to 840 mL of plasma could be safely and effectively collected in conjunction with saline infusion during plasmapheresis. STUDY DESIGN AND METHODS Ninety-one plasma donors were enrolled in a modified 3 x 3 crossover study to assess the equivalence of three plasma collection methods: 750 mL of plasma with no saline (control, Method 1), 840 mL of plasma with a 250-mL saline infusion during and at the end of the donation (Method 2), and 800 mL of plasma with a 500-mL saline infusion at the end of the donation (Method 3). The primary efficacy endpoint was the total protein concentration of the collected plasma. Secondary efficacy endpoints were immunoglobulin (Ig)G and Factor (F)VIII plasma concentration and donors' acceptance of the new procedures. Safety was determined from the adverse event (AE) rate. RESULTS The total protein, IgG, and FVIII concentrations in plasma collected under Methods 2 and 3 were significantly lower than those in plasma collected under Method 1 (p < 0.0001). These variables were also significantly lower in plasma collected under Method 2 compared to Method 3. During the study, 75 AEs were recorded, 73 of which were mild to moderate. Significantly more donors (31%) preferred Method 2 compared to Method 3 (p = 0.006). CONCLUSIONS Saline infusion during plasmapheresis led to hemodilution of plasma proteins. However, the benefits to donor safety and satisfaction are compelling reasons to implement saline infusion during plasmapheresis. 2012 American Association of Blood Banks