Hemostatic Efficacy and Safety of the Novel Medical Adhesive, MAR VIVO-107, in a Rabbit Liver Resection Model

Background: Topical hemostatic agents are useful when hepatic hemorrhage is difficult to control. The aim of this study was to evaluate the hemostatic efficacy and safety of a biodegradable polyurethane-based adhesive, MAR VIVO-107 (MAR), in comparison with a clinically used fibrin glue. Methods: Thirty female New Zealand white rabbits were randomly assigned to 3 study groups as follows: MAR (n = 10), fibrin glue (n = 10), and saline groups (n = 10). After standardized partial liver resection was performed, each agent was immediately applied to the wound area. Bleeding time until hemostasis and blood loss were recorded. After 7 days, body weight, hematology parameters, and serum levels of aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase were measured. Simultaneously, the severity of intra-abdominal adhesion was evaluated. Results: The mean bleeding time in the MAR (38 ± 10 s) and fibrin glue groups (65 ± 17 s) was significantly shorter than that in the saline group (186 ± 12 s). Similarly, the mean blood loss in the MAR (9 ± 3 g) and fibrin glue groups (9 ± 3 g) was significantly less than that in the saline group (23 ± 4 g). No significant differences in bleeding time and blood loss were found between the MAR and fibrin glue groups. The postoperative survival rate was 100% in all the groups. Body weight as well as hematological and serum biochemical values on day 7 were within the small and physiological range when compared with the preoperative baseline values, and significant differences were not detected among the MAR, fibrin glue, and saline groups. The severities of adhesion were similar between the 3 groups. Conclusion: Our data demonstrated that MAR was not inferior to fibrin glue in terms of hemostatic efficacy and safety.

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Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients

American Journal of Nephrology ◽

10.1159/000493097 ◽

2018 ◽

Vol 48 (4) ◽

pp. 251-259 ◽

Cited By ~ 2

Author(s):

Jalal Azmandian ◽

Mohammad Reza Abbasi ◽

Vahid Pourfarziani ◽

Amir Ahmad Nasiri ◽

Shahrzad Ossareh ◽

...

Keyword(s):

Body Weight ◽

Hemodialysis Patients ◽

Phase Iii ◽

Efficacy And Safety ◽

Epoetin Alfa ◽

Double Blind ◽

Epoetin Beta ◽

Significant Difference ◽

The Mean ◽

Stage Renal Disease

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10–12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10–12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

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Efficacy and safety of tolvaptan in patients with malignant ascites: a phase 2, multicenter, open-label, dose-escalation study

Japanese Journal of Clinical Oncology ◽

10.1093/jjco/hyaa196 ◽

2020 ◽

Author(s):

Toshihiro Kudo ◽

Yoshiyuki Murai ◽

Yoshitsugu Kojima ◽

Kenji Uehara ◽

Taroh Satoh

Keyword(s):

Body Weight ◽

Ascitic Fluid ◽

Dose Escalation ◽

Urine Volume ◽

Fluid Volume ◽

Phase 2 ◽

Efficacy And Safety ◽

Open Label ◽

Dose Escalation Study ◽

The Mean

Abstract Objective This phase 2 study examined the efficacy and safety of tolvaptan, an aquaretic drug, in the treatment of ascites associated with cancer. Methods In the dose-escalation phase, oral tolvaptan was initiated at a dose of 3.75 mg/day, and the dose was increased daily to 7.5, 15 and 30 mg/day. Dose escalation was terminated once the increase from baseline in the daily urine volume reached 500 ml, at which point the patient proceeded to the maintenance phase of 5–7 days. Improvement of ascites was determined primarily by reduction in body weight and ascitic fluid volume. Results The mean change from baseline in body weight was maintained below 0 kg throughout the study. The mean change (±standard deviation) from baseline in ascitic fluid volume at the end of treatment (EOT) was 237.45 ± 868.14 ml in 33 evaluable patients. Although an increase from baseline in ascitic fluid volume at the EOT was observed in 23 of 33 patients (maximum: 1589.3 ml, minimum: 3.83 ml), a reduction in ascitic fluid volume was observed in the remaining 10 patients (maximum: −2304.3 ml, minimum: −27.5 ml). The common treatment-emergent adverse events included vomiting (5 of 43 patients, 11.6%), abdominal distension, constipation, thirst, blood osmolarity increased and renal impairment (3 of 43 patients, 7.0% each). Conclusions Tolvaptan seemed to have no definitive effect on reducing ascites; however, it might be effective in at least some cancer patients. No new safety concerns were identified at doses of 3.75–30 mg/day.

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Efficacy and Safety of Fibrin Glue and Tranexamic Acid to Prevent Postoperative Blood Loss in Total Knee Arthroplasty

The Journal of Bone and Joint Surgery (American) ◽

10.2106/jbjs.l.01182 ◽

2013 ◽

Vol 95 (22) ◽

pp. 2001-2007 ◽

Cited By ~ 52

Author(s):

X. Aguilera ◽

M.J. Martinez-Zapata ◽

A. Bosch ◽

G. Urrútia ◽

J.C. González ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Blood Loss ◽

Tranexamic Acid ◽

Fibrin Glue ◽

Knee Arthroplasty ◽

Postoperative Blood Loss ◽

Efficacy And Safety ◽

Total Knee

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Treatment of irreducible atlantoaxial dislocation using one-stage retropharyngeal release and posterior reduction

Journal of Orthopaedic Surgery ◽

10.1177/2309499019870465 ◽

2019 ◽

Vol 27 (3) ◽

pp. 230949901987046 ◽

Cited By ~ 2

Author(s):

Xianfeng Ren ◽

Feng Gao ◽

Siyuan Li ◽

Jiankun Yang ◽

Yongming Xi

Keyword(s):

Blood Loss ◽

Operative Time ◽

Japanese Orthopaedic Association ◽

Operation Time ◽

Atlantoaxial Dislocation ◽

Efficacy And Safety ◽

Estimated Blood Loss ◽

Irreducible Atlantoaxial Dislocation ◽

The Mean

Introduction: Irreducible atlantoaxial dislocation (IAAD) has been challenging for spine surgeons. Various methods have been used to treat IAAD, but no consensus has been reached. This study aimed to retrospectively analyze the efficacy of anterior submandibular retropharyngeal release and posterior reduction and fixation for IAAD. Methods: From March 2007 to May 2015, 13 patients diagnosed with IAAD underwent anterior submandibular retropharyngeal release and sequential posterior reduction and fixation. The operation time, blood loss, postoperative complications, and Japanese Orthopaedic Association (JOA) scores were retrospectively recorded. Results: The surgeries were accomplished successfully. The mean operative time was about 3.8 h. The mean estimated blood loss was about 130 mL. The patients experienced postoperative pharyngeal pain. Only one patient had a vague voice and increased oral discharge postoperatively. At the final follow-up, JOA scores had significantly increased ( p < 0.05), and all the patients had solid bony fusion. Conclusion: The present study reinforces the efficacy and safety of anterior submandibular retropharyngeal release and posterior reduction and fixation for IAAD. It can achieve satisfactory clinical outcomes and is safe for experienced spine surgeons.

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Pharmacokinetics, Efficacy and Safety Of a Recombinant Factor IX (BAX326) In Previously-Treated Pediatric Patients < 12 Years Of Age With Severe Or Moderately Severe Hemophilia B

Blood ◽

10.1182/blood.v122.21.1118.1118 ◽

2013 ◽

Vol 122 (21) ◽

pp. 1118-1118 ◽

Cited By ~ 1

Author(s):

Tomasz Urasinski ◽

Oleksandra Stasyshyn ◽

Tatiana Andreeva ◽

Luminita Rusen ◽

Farida Perina ◽

...

Keyword(s):

Pediatric Patients ◽

Factor Ix ◽

Hemophilia B ◽

Ovary Cell ◽

Animal Origin ◽

Efficacy And Safety ◽

On Demand ◽

Previously Treated ◽

The Mean ◽

Hemostatic Efficacy

Abstract Hemophilia B is an X-linked congenital bleeding disorder caused by defective or deficient levels of circulating coagulation factor IX (FIX). Adequate levels of FIX can be maintained in the plasma through routine prophylactic infusions, which can especially benefit pediatric patients if started early in order to prevent recurrent joint bleeding and severe joint disease. A recombinant FIX (BAX326, Rixubis®, Baxter) has been developed for the prophylaxis and control of bleeding in hemophilia B patients. BAX326 is manufactured without the addition of any materials of human or animal origin; solvent/detergent treatment as well as nanofiltration are used for viral inactivation/reduction. Safety and efficacy of BAX326 have already been demonstrated in hemophilia B patients aged 12 years and above.1 A prospective clinical trial was conducted to assess the pharmacokinetics (PK), hemostatic efficacy and safety of BAX326 in previously treated patients (PTPs) <12 years of age with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B. After the initial PK assessment, BAX326 was administered as prophylaxis twice a week (median dose 56 IU/kg, range 43-75 IU/kg) over 6-months or for a minimum of 50 exposure days. Twenty-three male subjects (median age 7.10 years, range 1.8 to 11.8 years, with 11 subjects < 6 years) were enrolled and treated with BAX326. Sixteen subjects (69.6%) had received previous treatment with FIX products by prophylaxis only, 6 (26.1%) by both prophylaxis and on-demand, and 1 subject (4.3%) had been treated on-demand only. BAX326 was safe and well-tolerated. No allergic reactions or thrombotic events occurred and there were no treatment-related adverse events. None of the subjects developed an inhibitory or positive binding antibody to FIX, Chinese hamster ovary cell protein or furin. PK assessments (N = 23) after one 75 ± 5 IU/kg infusion with BAX326 were performed up to 72 hours (median AUC0-inf. 802.9 IU hr/dL, MRT 26.77 hr, Cl 0.0935 dL/[kg.hr], half-life 24.48 hr, Vss 2.629 dL/kg) using a non-linear mixed model (population PK) approach. The mean incremental recovery (IR) 30 minutes after infusion was consistent over time (assessed after initial PK infusion, and at 5, 14 and 26 weeks of treatment). A tendency toward higher IR in association with increased patient age was observed, as previously described.2 BAX326 administered as prophylaxis was efficacious in preventing bleeds. Nine subjects (39.1%) did not experience any bleeds; the mean annualized bleeding rate (ABR) was 2.7 ±3.14 (median 2.0). Out of 26 total bleeds, only 2 (in 2 subjects) were spontaneous, and 1 was of unknown cause. Fewer bleeds occurred in joints than in non-joint sites (19 non-joint vs. 7 joint bleeds). Hemostatic efficacy at the resolution of a bleed was excellent or good in 96.2% of bleeds. The majority of bleeds were resolved after 1-2 infusions (88.5%) with BAX326; the mean total dose of rFIX administered per bleed was 94.4 (52.41) IU/kg. Hemostatic efficacy in terms of bleed severity was excellent or good in 100% of minor bleeds (N =15), 88.9% of moderate bleeds (N=9) and 100% of major bleeds (N=2). In summary, these data indicate that BAX326 is safe and efficacious in treating bleeding episodes and in routine prophylaxis in pediatric patients aged <12 years with hemophilia B. Disclosures: Oh: Baxter: Employment. Chapman:Baxter: Employment. Pavlova:Baxter: Employment. Wong:Baxter: Employment. Abbuehl:Baxter: Employment.

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Prospective randomized trial comparing efficacy and safety of intravenous and intra-articular tranexamic acid in total knee arthroplasty

Knee Surgery and Related Research ◽

10.1186/s43019-020-00079-8 ◽

2020 ◽

Vol 32 (1) ◽

Author(s):

Moses Man-Lung Li ◽

Jojo Yan-Yan Kwok ◽

Kwong-Yin Chung ◽

Kin-Wing Cheung ◽

Kwok-Hing Chiu ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Body Weight ◽

Blood Transfusion ◽

Blood Loss ◽

Efficacy And Safety ◽

Significant Difference ◽

Group A ◽

Total Knee ◽

Group B ◽

Adjusted Dose

Abstract Background Total knee arthroplasty (TKA) is associated with significant perioperative blood loss and postoperative allogenic blood transfusion. Tranexamic acid (TXA) reversibly blocks lysine binding sites on plasminogen molecules and inhibits plasmin formation. Comparisons of the efficacy and safety of intra-articular and intravenous TXA in primary TKA have not previously been reported. Methods A prospective randomized trial was conducted in 150 patients who underwent TKA, and these patients were randomized into three groups. Patients in Group A were injected by intra-articular TXA according to body weight (20 mg/kg). Patients in Group B received a standard dose of intra-articular TXA (2000 mg), and those in Group C were infused with TXA according to body weight (20 mg/kg) before tourniquet deflation and again 3 h later. Baseline characteristics and data collected at blood transfusion were compared. Differences among four time points (baseline, day 0, day 2, and day 5) were carried out using ANOVA. Results The hemoglobin levels at postoperative day 5 were 10.6 g/dL for Group A, 10.6 g/dL for Group B, and 10.7 g/dL for Group C. The drain output was 399 ml for Group A, 314 ml for Group B, and 305 ml for Group C (p = 0.03). Group C had significantly less drain output than Group A after post hoc comparisons (p = 0.05), whereas no significant difference was observed between Group A and B (p = 0.09) or between Group B and C. Conclusion The weight-adjusted dose of TXA administered intravenously significantly reduced the drain output but not the total blood loss when compared with the weight-adjusted dose of TXA administered intra-articularly. No significant difference was observed in the other parameters among the three groups. Trial registration The Joint CUHK-NTEC CREC, CRE-2013.644-T. Registered 1 March 2014.

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Comparison between esmolol and verapamil in attenuation of cardiovascular stress response to laryngoscopy and endotracheal intubation in elective surgery

Asian Journal of Medical Sciences ◽

10.3126/ajms.v12i7.35759 ◽

2021 ◽

Vol 12 (7) ◽

pp. 64-68

Author(s):

Nitisha Chakraborty ◽

Sankar Roy ◽

Debajyoti Sur ◽

Arunava Biswas ◽

Dipasri Bhattacharya ◽

...

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

Body Weight ◽

Mean Arterial Pressure ◽

Arterial Pressure ◽

Diastolic Blood Pressure ◽

Endotracheal Intubation ◽

Efficacy And Safety ◽

Cardiovascular Stress ◽

The Mean

Background: Cardiovascular stress due to reflex sympathetic over activity is a great concern during laryngoscopy and endotracheal intubation. Aims and Objectives: To compare the efficacy and safety of esmolol and verapamil for attenuation of hemodynamic effects (heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) due to laryngoscopy and endotracheal intubation in elective surgical cases. Materials and Methods: A prospective, randomized, double blinded, controlled study was conducted on 60 patients divided equally into 30 each receiving esmolol (2 mg/kg body weight) and verapamil (0.1 mg/kg body weight) respectively. Heart rate, systolic and diastolic blood pressure and mean arterial pressure were recordedat pre-operative stage, after administration of the study drugs, immediately after intubation and at 1 ,3 ,5 minutes after intubation. Data collected were statistically analyzed. Results: The mean systolic blood pressure was lower in the esmolol group at all times of estimation compared with the verapamil group and the difference was at the time of intubation (p value <0.001).The mean diastolic blood pressure was lower in the esmolol group at all times of estimation compared to the verapamil group which was not statistically significant at any time of estimation. The mean arterial pressure was significantly lower at the time of immediately after intubation (p<0.001) in esmolol as compared to verapamil group. Adverse effects in both the study groups were insignificant. Conclusion: Esmololand Verapamil can effectively attenuate the cardiovascular stress to laryngoscopy and endotracheal intubation with the former appears to be a better alternative from efficacy and safety perspectives.

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Ứng dụng dao siêu âm Sonastar trong phẫu thuật cắt gan

Journal of Clinical Medicine- Hue Central Hospital ◽

10.38103/jcmhch.2020.65.19 ◽

2020 ◽

Author(s):

Hien Pham Nhu

Keyword(s):

Liver Resection ◽

Blood Loss ◽

Operative Time ◽

Resection Margin ◽

Operation Time ◽

Bile Leakage ◽

Hepatic Veins ◽

Early Results ◽

Solitary Liver ◽

The Mean

Background: Researching specification and evaluating early results after hepatectomy that it’s used with Sonastar ultrasonic tool. Materials and methods: We prospectively examined data of 19 patients who underwent hepatectomy at Hue Central Hospitalfrom 7/2019to 7/2020. Results: The mean ages was 60,7 ± 10,5 range (19 – 90) and males/females was 6:1.. Patients with solitary liver tumor accounted for 79%; while tumors that have satellite cores accounted for 21% of all cases. 68,4% of all patients have tumor that is more than 5cm in size. Blocking hepatic blood flow by clamping of hepatoduodenal ligament accounts for 57,9%, while right and left hepatic vein clamp accounted for 68,4% and 36,8% respectively. In 78,9% of the cases, surgicel was used to cover the liver resection margin, while the in the remainder 21,5% of the cases, BioGlue was used. Large liver resection (2 and more lobes resected) accounted for 73,7% of all cases. Mean liver resection time was 50 ( 45-110) minutes, mean operation time was 125 (90-280) minutes, mean blood loss amount was 250 (150-650)ml. On average, post-operative time was 8 days (7-23). Post-operative complications was observed in 15,9% of cases, and there was 5,3% deceased. Conclusion: Application of Sonastar ultrasonic tool in hepatectomy reduces blood loss, help better manage hepatic veins, thus reducing complications such as bile leakage. It also helps surgeons manage the liver resection margin, minimalizing recurrences cancer

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Non-Occlusive Bleeding Times May Improve the Value of Ivy Bleeding Times

Thrombosis and Haemostasis ◽

10.1055/s-0038-1645049 ◽

1990 ◽

Vol 63 (03) ◽

pp. 371-374 ◽

Cited By ~ 4

Author(s):

Zella R Zeigler

Keyword(s):

Blood Loss ◽

Clinical Evidence ◽

Bleeding Time ◽

Bone Marrow Failure ◽

Venous Occlusion ◽

Spontaneous Bleeding ◽

Heterogeneous Behavior ◽

The Mean ◽

Aspirin Ingestion ◽

Normal Controls

SummaryThe present studies measured bleeding times, without venous occlusion, in a series of patients, whose bleeding times (+ venostasis) consistently exceeded 20 min. During these tests, the amount of blood loss (expressed as mg/min) was also quantitated. To allow comparison, normal controls were studied before and following aspirin ingestion. In normal controls, the mean standard Ivy bleeding time was 5.0 with a range of 2.5 to 7.5 min. Two hours after aspirin (650 mg), this increased to 7.3 min (range 4.0−12.0). For comparison, the non-occlusive bleeding time averaged 3.8 min (1.0−6.5) and after aspirin 5.3 min (2.5−11.5). The measured amount of blood loss was 5.0 mg/min (0−10.5 mg/ min) under all of the above conditions. At the other extreme, patients with severe bone marrow failure had occluded and nonoccluded bleeding times in excess of 20 min. Moreover, these were often associated with excess blood loss. By contrast, patients with “Ivy” values >20 min in association with platelet counts >10,000/μl had unpredictable bleeding parameters. In the latter group, the non-occluded values ranged from 1 to >20 min. Of particular note, the non-occlusive times appeared to correlate with spontaneous bleeding manifestations. Only a rare patient (1/37), whose non-occluded value was <20 min, had worrisome bleeding. By contrast, serious bleeding manifestations were observed in 39% whose non-occluded value exceeded 20 min. This was even higher (64%) in those with a non-occluded value >20 min and excess blood loss. These studies provide laboratory and clinical evidence for the heterogeneous behavior of patients with venostasis bleeding times >20 min. These additional laboratory measurements may be helpful in defining risk of spontaneous bleeding and in evaluating therapeutic strategies in such patients. However, studies will need to be performed to correlate this type of information with bleeding associated with invasive diagnostic or surgical procedures.

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Real-world Efficacy and Safety of Dulaglutide in Korean Patients with Type 2 Diabetes Mellitus: A Retrospective Study in a Tertiary Referral Center

10.21203/rs.3.rs-59508/v1 ◽

2020 ◽

Author(s):

Jee Hee Yoon ◽

A Ram Hong ◽

Wonsuk Choi ◽

Ji Yong Park ◽

Hee Kyung Kim ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Body Weight ◽

Efficacy And Safety ◽

Tertiary Referral ◽

Tertiary Referral Center ◽

Korean Patients ◽

The Mean

Abstract Background: This study was conducted to evaluate the efficacy and safety of once-weekly dulaglutide therapy as add-on to oral antidiabetic drugs (OADs) and basal insulin in Korean patients with type 2 diabetes mellitus (T2DM) in the real-world clinical practice.Methods: We retrospectively reviewed the medical records of 112 patients who received dulaglutide in a tertiary referral center. The primary efficacy endpoint was a change in glycated hemoglobin (HbA1c) between baseline and 6 months. The secondary endpoints were the percentage of patients achieving HbA1c <7.0% or ≤6.5% and the change of body weight at 6 months. Results: At baseline, the mean HbA1c was 8.7 % (8.8% in the add-on to OAD and 8.5% in the add-on to insulin group). The mean adjusted HbA1c at 6 months decreased by −1.13% in the overall patients (p < 0.001), and by −1.36 and −0.74% in the add-on to OAD and add-on to insulin group, respectively. A significant reduction of −2.9 kg in body weight was observed in the overall patients at 6 months (p < 0.001). Approximately 34.8% and 23.2% of patients achieved HbA1c <7.0% and ≤6.5%, respectively. Higher baseline HbA1c and no previous insulin therapy were associated with good response to dulaglutide on multivariate analysis. In subgroup analysis to evaluate the long-term efficacy of dulaglutide (n=82), the mean adjusted HbA1c decreased by −0.86% from baseline to 12 months (p < 0.001). Mild gastrointestinal issues (23.2%) were the most frequently observed adverse events.Conclusions: Dulaglutide is an effective and durable treatment option as add-on to OAD and basal insulin therapy in Korean patients with T2DM.

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