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Efficacy and Safety of a Thrombin-Containing Collagen-based Haemostatic Agent in Spinal Surgery: A Randomized Clinical Trial
Park SM, Kang DR, Lee JH, Jeong YH, Shin DA, Yi S, Ha Y, Kim KN
World neurosurgery. 2021
Abstract
OBJECTIVE When common haemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local haemostatic agents are used. We aimed to evaluate the haemostatic efficacy and safety of CollaStat® (Dalim Tissen Co. Ltd., Korea), a novel thrombin-containing collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal® (Baxter Healthcare, USA). METHODS We performed a randomised controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat®) or a control group (use of Floseal®). We compared successful haemostasis rate, time to haemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the two groups. RESULTS The haemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal® since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal® was greater than the pre-specified non-inferiority margin of -13%. There were no statistically significant differences at the 5% level in haemostasis time, number of haemostatic agents used, hospitalisation period, and amount of drainage between the two groups. Also, there was no incidence of medical device-related serious adverse events (SAEs) or adverse events (AEs) in both groups. CONCLUSION The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal®. Therefore, CollaStat® can be safely and effectively used in spinal surgery.
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Effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after pancreatectomy: A randomized clinical trial
Park Y, Ko JH, Kang DR, Lee JH, Hwang DW, Lee JH, Lee W, Kwon J, Park SN, Song KB, et al
Annals of hepato-biliary-pancreatic surgery. 2021;25(Suppl 1):S371
Abstract
INTRODUCTION The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effect for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 54 patients, with 26 patients in the intervention group (flowable hemostatic matrix) and 27 patients in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy (DP), POPF (33.3% vs. 92.3%, p = 0.004) and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) were more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use (p = 0.029) as an independent negative risk factor for POPF. CONCLUSIONS Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP.
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Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
Park Y, Ko JH, Kang DR, Lee JH, Hwang DW, Lee JH, Lee W, Kwon J, Park SN, Song KB, et al
Journal of clinical medicine. 2020;9(10)
Abstract
BACKGROUND The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453-207.870, p = 0.024). CONCLUSION Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.
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Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis
Lee JH, Chung BH, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, et al
Current medical research and opinion. 2018;:1-17.
Abstract
OBJECTIVE To evaluate the efficacy and safety of CKD-11101 (biosimilar darbepoetin-alfa, Chong Kun Dang Pharm.) compared with NESP(R) in treatment of anaemia in patients with chronic kidney disease not on dialysis. CLINICAL TRIAL REGISTRATION NCT03431623. METHOD In this multicentre, randomized, double-blind study, patients were treated with CKD-11101 and NESP. The efficacy evaluation period (EEP) was 24 weeks, during which patients were treated every 2 weeks. All patients who completed the EEP were treated with CKD-11101 every 2 weeks for the first four weeks and every 4 weeks for the safety evaluation period (SEP), which was from 24 weeks to 52 weeks. The primary efficacy endpoint was the change in mean haemoglobin (Hb) level from baseline to end of EEP and mean dose needed to achieve the target Hb. RESULTS The mean Hb level was increased in both groups during the EEP (both P < 0.001). The difference in mean Hb level change between the two groups was 0.01g/dL (95% CI -0.213, 0.242), indicating that CKD-11101 was equivalent to NESP. The difference in mean administration dose between groups was -1.40mcg (95% CI -6.859, 4.059) included in the equivalent range. The incidence of AEs and ADRs was not different between the two groups, and the frequency of ADRs was favourable in both groups (1.2% in CKD-11101 vs 7.7% in the NESP to CKD-11101 conversion group). CONCLUSION CKD-11101 has an equivalent therapeutic effect as NESP in chronic kidney disease patients with renal anaemia. CKD-11101 can be safely used for long-term treatment and in patients converted from NESP.
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Effect of intravenous ferric carboxymaltose on hemoglobin response among patients with acute isovolemic anemia following gastrectomy: the FAIRY randomized clinical trial
Kim YW, Bae JM, Park YK, Yang HK, Yu W, Yook JH, Noh SH, Han M, Ryu KW, Sohn TS, et al
Jama. 2017;317((20)):2097-2104.
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Abstract
Importance: Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. Objective: To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. Design, Setting, and Participants: The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. Interventions: Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). Main Outcomes and Measures: The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. Results: Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. Conclusion and Relevance: Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. Trial Registration: clinicaltrials.gov Identifier: NCT01725789.
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Erythromycin infusion prior to endoscopy for acute nonvariceal upper gastrointestinal bleeding: a pilot randomized controlled trial
Na HK, Jung HY, Seo DW, . Lim H, Ahn JY, Lee JH, Kim DH, Choi KD, Song HJ, Lee GH, et al
The Korean Journal of Internal Medicine. 2017;32((6):):1002-1009
Abstract
Background/Aims: The aim of this study was to compare the effects of erythromycin infusion and gastric lavage in order to improve the quality of visualization during emergency upper endoscopy. Methods: We performed a prospective randomized pilot study. Patients presented with hematemesis or melena within 12 hours and were randomly assigned to the erythromycin group (intravenous infusion of erythromycin), gastric lavage group (nasogastric tube placement with gastric lavage), or erythromycin + gastric lavage group (both erythromycin infusion and gastric lavage). The primary outcome was satisfactory visualization. Secondary outcomes included identification of a bleeding source, the success rate of hemostasis, duration of endoscopy, complications related to erythromycin infusion or gastric lavage, number of transfused blood units, rebleeding rate, and bleeding-related mortality. Results: A total of 43 patients were randomly assigned: 14 patients in the erythromycin group; 15 patients in the gastric lavage group; and 14 patients in the erythromycin + gastric lavage group. Overall satisfactory visualization was achieved in 81% of patients: 92.8% in the erythromycin group; 60.0% in the gastric lavage group; and 92.9% in the erythromycin + gastric lavage group, respectively (p = 0.055). The identification of a bleeding source was possible in all cases. The success rate of hemostasis, duration of endoscopy, and number of transfused blood units did not significantly differ between groups. There were no complications. Rebleeding occurred in three patients (7.0%). Bleeding-related mortality was not reported. Conclusions: Intravenous erythromycin infusion prior to emergency endoscopy for acute nonvariceal upper gastrointestinal bleeding seems to provide satisfactory endoscopic visualization.
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Safety and tolerability of eltrombopag versus placebo for treatment of thrombocytopenia in patients with advanced myelodysplastic syndromes or acute myeloid leukaemia: a multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial
Platzbecker U, Wong RS, Verma A, Abboud C, Araujo S, Chiou TJ, Feigert J, Yeh SP, Gotze K, Gorin NC, et al
The Lancet Haematology. 2015;2((10)):e417-26.
Abstract
BACKGROUND Patients with myelodysplastic syndrome or acute myeloid leukaemia who are thrombocytopenic and unable to receive disease-modifying therapy have few treatment options. Platelet transfusions provide transient benefit and are limited by alloimmunisation. Eltrombopag, an oral thrombopoietin receptor agonist, increases platelet counts and has preclinical antileukaemic activity. We aimed to assess the safety and tolerability of eltrombopag for the treatment of thrombocytopenia in adult patients with advanced myelodysplastic syndrome, secondary acute myeloid leukaemia after myelodysplastic syndrome, or de-novo acute myeloid leukaemia. METHODS We did this multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial at 37 centres in ten countries in Europe, east Asia, and the Americas. Patients aged 18 years or older who had relapsed or refractory disease or were ineligible for standard treatments; had platelet counts of less than 30 x 10(9) platelets per L; had 10-50% bone-marrow blasts; or were platelet transfusion dependent were randomly assigned (2:1), via a telephone-based interactive voice-response system (GlaxoSmithKline Registration and Medication Ordering System) with a permuted-block randomisation schedule (block size of three), to receive once-daily eltrombopag or matching placebo dose adjusted from 50 mg to a maximum dose of 300 mg. Randomisation was stratified by presence of poor-prognosis (complex) karyotype (presence of at least three abnormalities, or chromosome 7 abnormalities, vs absence) and bone-marrow blast count (<20% vs >20%). Patients and study personnel were masked to treatment allocation. The primary endpoint was safety and tolerability, including adverse events, non-haematological laboratory grade 3-4 toxic effects, and changes in bone-marrow blast counts from baseline. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00903422. FINDINGS Between May 14, 2009, and May 9, 2013, we randomly assigned 98 patients to receive either eltrombopag (n=64) or placebo (n=34). 63 (98%) patients in the eltrombopag group and 32 (94%) patients in the placebo group had adverse events. The most common adverse events were pyrexia (27 [42%] vs 11 [32%]), nausea (20 [31%] vs 7 [21%]), diarrhoea (19 [30%] vs 6 [18%]), fatigue (16 [25%] vs 6 [18%]), decreased appetite (15 [23%] vs 5 [15%]), and pneumonia (14 [22%] vs 8 [24%]). Drug-related adverse events of grade 3 or higher were reported in six (9%) patients in the eltrombopag group and four (12%) patients in the placebo group. Increases in the proportion of peripheral blasts did not differ significantly between groups. Haemorrhage of grade 3 or higher was reported in ten (16%) patients given eltrombopag and nine (26%) patients given placebo. 21 (33%) patients receiving eltrombopag and 16 (47%) patients receiving placebo died while on treatment. No deaths in patients receiving eltrombopag and two deaths in patients receiving placebo were regarded as treatment related. Post-baseline bone-marrow examinations were done in 40 (63%) patients in the eltrombopag group and 17 (50%) patients in the placebo group. The most common reason for no examination was death before the scheduled 3 month assessment. There were no differences between median bone-marrow blast counts or proportions of peripheral blasts between groups. INTERPRETATION Eltrombopag doses up to 300 mg daily had an acceptable safety profile in patients with advanced myelodysplastic syndrome or acute myeloid leukaemia. The role of eltrombopag in these patients warrants further investigation. FUNDING GlaxoSmithKline.Copyright © 2015 Elsevier Ltd. All rights reserved.
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A randomized crossover study of single biweekly administration of epoetin-alpha compared with darbepoetin-alpha in chronic kidney disease patients not receiving dialysis
Na HY, Lee YK, Shin SK, Yang DH, Cheon W, Park JH, Lee JH, Song JO, Jo YI
Kidney Research and Clinical Practice. 2014;33((4)):210-6.
Abstract
BACKGROUND Recent evidence demonstrates that high doses of epoetin-alpha (EPO-alpha) can be administrated at extended intervals, despite its relatively short serum half-life. However, no prospective randomized trials on the effects of extended dosing intervals of EPO-alpha compared with darbepoetin-alpha (DA-alpha) have been performed. This study was designed to investigate whether a single biweekly (Q2W) administration of a high dose of EPO-alpha is as effective as DA-alpha for anemia in chronic kidney disease (CKD) patients not receiving dialysis. METHODS Sixty non-dialysis CKD patients were equally randomized to either Q2W subcutaneous EPO-alpha (10,000 unit) or DA-alpha (50 mug) therapy groups for the first 6 weeks. After a 6-week washout period, the participants of the EPO-alpha and DA-alpha treatment groups switched to the alternate regimen for 6 weeks. The mean hemoglobin (Hb) levels after erythropoiesis stimulating agent (ESA) therapy and percentage change in Hb levels from baseline to the end of the study were analyzed. RESULTS The mean Hb levels of postESA therapy increased significantly compared with those of preESA therapy in both ESA regimens. The percentage increase in Hb levels and erythropoietin resistance index did not show a significant difference between the different ESA regimens. No difference was observed between the regimens regarding mean Hb levels after ESA therapy. Additionally, there were no serious adverse effects leading to withdrawal from treatment. CONCLUSION Biweekly high doses of EPO-alpha therapy may be equally as effective as Q2W DA-alpha therapy in maintaining target Hb levels in non-dialysis CKD patients. IS 2211-9132 IL 2211-9132
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Clinical value of tranexamic acid in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol: a randomized controlled trial
Kim TK, Chang CB, Kang YG, Seo ES, Lee JH, Yun JH, Lee SH
Knee Surgery, Sports Traumatology, Arthroscopy. 2014;22((8):):1870-8.
Abstract
PURPOSE Despite the documented blood-saving effects of tranexamic acid (TNA) in total knee arthroplasty (TKA), the question whether clinical values of TNA are identical in unilateral and bilateral TKAs remains unclear. This study was undertaken to determine the clinical values of TNA in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol in terms of efficacy (total blood loss and transfusion rate) and safety (the incidences of symptomatic deep vein thrombosis and pulmonary embolism). METHODS One hundred and eighty unilateral and 146 bilateral TKA patients were randomized into TNA group or control group. In unilateral TKA patients, TNA (10 mg/kg) was administered intravenously 20 min before tourniquet deflation and repeated 3 h after surgery. In bilateral TKA patients, one more dose (10 mg/kg) was given before tourniquet deflation in the second TKA. A contemporary blood-saving protocol was applied to all patients. The TNA and control groups were compared separately in unilateral and bilateral TKA patients for the efficacy and safety variables. RESULTS In unilateral TKA patients, the TNA group had less total blood loss (905 vs. 1,018 mL, p = 0.018) than the control group, but there was no difference in the allogenic transfusion rate (1 vs. 7 %, n.s.). In bilateral TKA patients, the TNA group showed no differences in total blood loss (1,282 vs. 1,379 mL, n.s.), but a significant reduction in the allogenic transfusion rate (7 vs. 27 %, p = 0.002). No symptomatic deep vein thrombosis or pulmonary embolism was found in all patients. CONCLUSION This study demonstrates that the use of TNA reduces total blood loss, but the effects on the transfusion rate can differ depending on the type of TKAs (unilateral vs. bilateral) and the blood-saving protocols. LEVEL OF EVIDENCE Therapeutic study, Level I (double blind randomized controlled trial).
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Oral tranexamic acid enhances the efficacy of low-fluence 1064-nm quality-switched neodymium-doped yttrium aluminum garnet laser treatment for melasma in Koreans: a randomized, prospective trial
Shin JU, Park J, Oh SH, Lee JH
Dermatologic Surgery. 2013;39((3, Pt 1):):435-42.
Abstract
BACKGROUND Tranexamic acid (TA) has recently gained in popularity in the treatment of pigmentary disorders. OBJECTIVE To evaluate the clinical efficacy and safety of oral TA combined with low-fluence 1064-nm quality-switched neodymium-doped yttrium aluminum garnet (QSNY) laser for the treatment of melasma. MATERIALS AND METHODS Forty-eight patients with melasma were enrolled in the study and subsequently divided into two groups: a combination group and a laser treatment group. All patients were treated with two sessions of low-fluence QSNY laser, and patients in the combination group took 8 weeks of oral TA. Two blinded dermatologists evaluated patients using the Modified Melasma Area and Severity Index (mMASI) and a clinical improvement scale. RESULTS Mean mMASI score 4weeks after the second treatment decreased significantly in both groups from base line. Based on overall clinical improvement, a greater number of patients scored as grade 3 and more in the combination group; no patients were scored as grade 4 in the laser-alone group. CONCLUSIONS Oral TA may prove a safe and efficient treatment option for melasma in combination with low-fluence QSNY laser therapy. 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.