Efficacy of intrauterine Bakri balloon tamponade combined with ascending uterine artery ligation on postpartum hemorrhage
American journal of translational research. 2021;13(5):4995-5002
OBJECTIVE To observe the efficacy of intrauterine Bakri balloon tamponade (IBBT) combined with ascending uterine artery ligation (AUAL) in the treatment of postpartum hemorrhage (PPH) due to uterine inertia after cesarean section. METHODS A total of 92 patients with PPH due to uterine inertia after cesarean section were divided into a study group (n=46) and a control group (n=46) in accordance with the random number table. The control group was treated with IBBT alone, while the study group was treated with IBBT combined with AUAL. The clinical efficacies, hemorrhage, surgical duration, hospital stay, hemorrhage rate after removal of tamponade, recurrence rate of PPH, changes in coagulation function and quality of life were compared between the two groups. RESULTS The overall response rate (ORR) in the study group was 95.65%, remarkably higher than that of 80.43% in the control group (P < 0.05). The study group had a lesser amount of hemorrhage at 2 h and 24 h after surgery, a longer surgical duration, a shorter hospital stay, and lower hemorrhage rate after removal of tamponade and recurrence rate of PPH than the control group (P < 0.05). After treatment, prothrombin time, activated partial thromboplastin time and fibrinogen in the study group were markedly higher than those in the control group (P < 0.05). Compared with those before treatment, the scores of quality of life in the two groups were elevated at 3 months after treatment (P < 0.05), and the scores of quality of life in the study group were higher than those in the control group at 3 months after treatment (P < 0.05). CONCLUSION IBBT combined with AUAL can effectively alleviate hemorrhage and improve coagulation function and quality of life of patients with PPH due to uterine inertia after cesarean section, exhibiting a definite efficacy and a high safety profile.
Holmium laser enucleation of the prostate with Virtual Basket mode: faster and better control on bleeding
BMC urology. 2021;21(1):28
BACKGROUND To compare clinical intra and early postoperative outcomes between conventional Holmium laser enucleation of the prostate (HoLEP) and Holmium laser enucleation of the prostate using the Virtual Basket tool (VB-HoLEP) to treat benign prostatic hyperplasia (BPH). METHODS This prospective randomized study enrolled consecutive patients with BPH, who were assigned to undergo either HoLEP (n = 100), or VB-HoLEP (n = 100). All patients were evaluated preoperatively and postoperatively, with particular attention to catheterization time, operative time, blood loss, irrigation volume and hospital stay. We also evaluated the patients at 3 and 6 months after surgery and assessed maximum flow rate (Qmax), postvoid residual urine volume (PVR), the International Prostate Symptom Score (IPSS) and the Quality of Life score (QOLS). RESULTS No significant differences in preoperative parameters between patients in each study arm were found. Compared to HoLEP, VB-HoLEP resulted in less hemoglobin decrease (2.54 vs. 1.12 g/dl, P = 0.03) and reduced operative time (57.33 ± 29.71 vs. 42.99 ± 18.51 min, P = 0.04). HoLEP and VB-HoLEP detrmined similar catheterization time (2.2 vs. 1.9 days, P = 0.45), irrigation volume (33.3 vs. 31.7 l, P = 0.69), and hospital stay (2.8 vs. 2.7 days, P = 0.21). During the 6-month follow-up no significant differences in IPSS, Qmax, PVR, and QOLS were demonstrated. CONCLUSIONS HoLEP and VB-HoLEP are both efficient and safe procedures for relieving lower urinary tract symptoms. VB-HoLEP was statistically superior to HoLEP in blood loss and operative time. However, procedures did not differ significantly in catheterization time, hospital stay, and irrigation volume. No significant differences were demonstrated in QOLS, IPSS, Qmax and PVR throughout the 6-month follow-up. TRIAL REGISTRATION Current Controlled Trials ISRCTN72879639; date of registration: June 25th, 2015. Retrospectively registred.
The European Medicines Agency Review of Crizanlizumab for the Prevention of Recurrent Vaso-Occlusive Crises in Patients With Sickle Cell Disease
Crizanlizumab is a monoclonal antibody that binds to P-selectin. On October 28, 2020, a conditional marketing authorization valid through the European Union (EU) was issued for crizanlizumab for the prevention of recurrent vaso-occlusive crises (VOCs) in patients with sickle cell disease aged 16 years or older. Crizanlizumab was evaluated in a phase 2, double-blind, placebo-controlled randomized multicenter trial comparing high-dose (5 mg/kg) crizanlizumab, low-dose (2.5 mg/kg) crizanlizumab and placebo in patients with a history of 2-10 VOCs in the previous year. Patients who were receiving concomitant hydroxycarbamide (HC) as well as those not receiving HC were included in the study. The primary endpoint of the trial was the annual rate of sickle cell-related pain crises as adjudicated by a central review committee. High-dose crizanlizumab led to a 45.3% lower median annual rate of sickle cell-related pain crises compared to placebo (P = 0.010), with no statistically significant difference for the low dose. Treatment with high-dose crizanlizumab led to similar incidences of adverse events (AEs), grade 3 AEs, and serious AEs compared to placebo. Most frequently observed AEs that occurred more often in the crizanlizumab arm compared to placebo were infusion related reactions (34.8% versus 21%), arthralgia (18.2% versus 8.1%), diarrhea (10.6% versus 3.2%), and nausea (18.2% versus 11.3%). The aim of this article is to summarize the scientific review of the application leading to regulatory approval in the EU.
Observation on the clinical effect of high-dose Intravenous Immunoglobulin combined with low-dose prednisone acetate in the treatment of patients with Kawasaki Disease
Pakistan journal of medical sciences. 2021;37(4):1122-1127
OBJECTIVE To evaluate the clinical effect of high-dose intravenous immunoglobulin (HDIVIG) single dose and pulse therapy combined with small-dose prednisone acetate in the treatment of patients with Kawasaki disease (KD). METHODS Eighty patients with KD from Baoding Children's Hospital, China, were randomly divided into two groups: the experimental group and the control group, each with 40 cases. Patients in the experimental group were treated with HDIVIG single dose, pulse therapy combined with low-dose prednisone acetate, while patients in the control group were treated with conventional-dose immunoglobulin. Patients in both groups were treated with aspirin orally, and given symptomatic treatment including anti-inflammatory, nutritional support, correction of water and electrolyte disturbance and acid-base balance. Peripheral venous blood samples were drawn from all patients at the time of admission, Day-1, Day-7 and Day-14 after treatment, and in the basic state of getting up in the morning, and then the levels of tumor necrosis factor (TNF-a), C-reactive protein (CRP), interleukin-6 (IL-6) and other inflammatory factors were detected by enzyme-linked immunosorbent assay (ELISA). The time of body temperature falling to normal, lymph node swelling recovery, hands and feet swelling, mucosal hyperemia regression after treatment in the two groups was recorded, and the treatment effect of the two groups was comprehensively evaluated. RESULTS After treatment, the levels of inflammatory factors such as TNF-a, CRP, IL-6 in the experimental group were significantly lower than those in the control group, with a statistically significant difference (P<0.05). In addition, the time of body temperature falling to normal, lymph node swelling recovery, hands and feet swelling, and mucosal hyperemia regression in the experimental group was significantly shorter than that in the control group (p=0.00). The effective rate of the experimental group was 95% and that of the control group was 80%, with a statistically significant difference (p=0.04). CONCLUSION HDIVIG single dose, pulse therapy combined with small-dose prednisone acetate has a favourable therapeutic effect in the treatment of patients with KD, by which the inflammatory factors can be significantly improved, clinical symptoms and weight can be quickly ameliorated, and therapeutic effect can be enhanced.
Effect of the piezoelectric device on intraoperative hemorrhage control and quality of life after endodontic microsurgery: a randomized clinical study
Journal of endodontics. 2021
INTRODUCTION The purpose of this study is to evaluate the effect of the piezoelectric device on intraoperative hemorrhage control during surgery and the quality of life of patients after the endodontic microsurgery. METHODS A total of 40 patients were randomly divided into the piezo group (n=20) and the control group (n=20). In the piezo group after flap reflection bone cutting, granulation tissue removal, and root-end resection were performed using the piezoelectric surgical device and surgical carbide burs and curettes were used in the control group. The quality of life of patients was evaluated daily for one week postsurgery for limitations of oral and general functions, pain, and other symptoms. Limitation of functions and other symptoms were recorded by a modified version of the patient's perception questionnaire using a five-point Likert scale for mouth opening, chewing, speaking, sleeping, daily routine, missed work, swelling, nausea, bad taste/breath and VAS was adopted for pain. Hemorrhage control during surgery was independently assessed by the surgeon and two blinded observers and recorded as 0(No hemorrhage control), 1(intermittent control), and 2(complete control).Chi(_)square test was used to assess hemorrhage control. For variables related to function and symptoms other than pain, and analgesics taken Fisher exact test was used. For assessment of pain between two groups, Mann-Whitney was used. RESULTS For parameters of quality of life piezo group showed significantly less swelling on 1(st),2(nd)& 3(rd)day and pain on 1(st)& 2(nd) day as compared with the control group "p<0.05." Analgesics taken were also significantly less in the piezo group "p<0.05". In the Piezo group, complete hemorrhage control was achieved in 10 patients, and in the control group, it was achieved only in 1 patient "P < .05." CONCLUSIONS Piezoelectric surgery resulted in improved quality of life of patients in the first weekpostsurgery with lower levels of pain and swelling as well as the number of analgesics taken and better hemorrhage control during surgery.
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.
Utility of autologous fibrin glue in the donor site of free abdominal flap for breast reconstruction: A randomized controlled study
Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 2021
BACKGROUND Seroma formation at the donor site is a common complication of breast reconstruction using free abdominal flap. In this study, we assessed the benefits of use of autologous fibrin glue (AFG) at the donor site. METHODS This randomized controlled study compared AFG group (n = 61) with commercial fibrin glue (CFG) group (n = 79). Owing to the high volume of AFG (10 mL), AFG group received fibrin glue at both the anastomosis and the donor sites, whereas CFG group received fibrin glue only at the anastomosis site. Operative protocols and the criteria for postoperative drain removal were identical in both groups. Patient characteristics and abdominal discharge were compared between the two groups. RESULTS Since anemia was a contraindication for use of AFG, preoperative Hb in CFG group was significantly lower than that in AFG group; other factors were comparable in the two groups. The mean total abdominal drain volumes on first postoperative day (POD1) and POD2 was (AFG vs. CFG) 130.9 vs. 169.4 mL (P < 0.001) and 131.0 vs. 162.8 mL (P = 0.03), respectively. On POD3, there was no significant difference in this respect (116.2 vs. 128.4 mL, P = 0.19). The mean time for removal of all abdominal drains was significantly lower in AFG group (7.4 vs. 8.4 days; P = 0.01). CONCLUSIONS AFG reduced the discharge at the donor site of free abdominal flap, especially in the early postoperative period. AFG helped to reduce the abdominal drainage period.
The Effect of Tranexamic Acid Administration on Early Endothelial Damage Following Posterior Lumbar Fusion Surgery
Journal of clinical medicine. 2021;10(7)
Tranexamic acid (TXA) protects against endothelial glycocalyx injury in vitro. We aimed to evaluate whether TXA could protect against endothelial glycocalyx degradation in patients undergoing posterior lumbar fusion surgery. Patients aged 30-80 years were enrolled. The TXA group was administered a loading dose of 10 mg/kg, followed by a 1 mg/kg/h infusion. Serum syndecan-1 and heparan sulfate concentrations, which are biomarkers of glycocalyx degradation, were measured at preoperative baseline (T0), immediately post-surgery (T1), and 2 h post-surgery (T2). Postoperative complications were assessed, including hypotension, desaturation, and acute kidney injury. Among the 121 patients who completed the study, 60 received TXA. There were no significant differences in the marker concentrations at each time point. However, the postoperative increase in syndecan-1 levels from baseline was significantly attenuated in the TXA group compared with the control group (median (interquartile range); T1 vs. T0: -1.6 (-5.3-2.6) vs. 2.2 (-0.7-4.8), p = 0.001; T2 vs. T0: 0.0 (-3.3-5.5) vs. 3.6 (-0.1-9.3), p = 0.013). Postoperative complications were significantly associated with the magnitude of the change in syndecan-1 levels (for T2 vs. T0: odds ratio: 1.08, 95% confidence interval: 1.02-1.14, p = 0.006). TXA administration was associated with reduced syndecan-1 shedding in patients undergoing posterior lumbar fusion surgery.
Multimodal Peri-articular Injection with Tranexamic Acid can reduce postoperative blood loss versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Trial
Journal of orthopaedic surgery and research. 2021;16(1):546
BACKGROUND Tranexamic acid (TXA) has shown significant reductions in blood loss and transfusion rates in total knee arthroplasty (TKA). However, the optimal administration route continues to be debated. The aim of this trial was to compare the effectiveness of intravenous (IV) versus peri-articular injection (PAI) application of tranexamic acid in patients undergoing total knee arthroplasty. METHODS We conducted a randomized controlled, double-blinded study. A total of 93 patients undergoing primary unilateral TKA were randomly distributed between 2 groups: the IV group (47 cases; 1 g TXA IV) and the PAI group (46 cases; 1 g TXA injected peri-articularly). The amount of total and hidden blood loss (HBL), drainage, transfusion rate, hemoglobin and hematocrit drift, and complications were recorded. RESULTS Peri-articular injection of TXA reduced total blood loss (P < 0.001) and HBL more than IV use of TXA (P < 0.001). No patients in either group received a transfusion. No symptomatic deep venous thrombosis or other severe complications occurred. CONCLUSION Peri-articular injection of TXA significantly reduced total blood loss and hidden blood loss to a greater degree than IV injection in total knee arthroplasty without reduction of drainage volume. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-INR-16010270 . Date of registration: December 27, 2016.
A Single Dose of Tranexamic Acid Reduces Blood Loss After Reverse and Anatomic Shoulder Arthroplasty: A Randomized Control Trial
Journal of shoulder and elbow surgery. 2021
BACKGROUND Hematoma formation and blood transfusions are commonly reported complications after shoulder arthroplasty. Tranexamic acid (TXA) has been widely used in hip and knee arthroplasty to decrease perioperative blood loss. The role of TXA is still being established in shoulder arthroplasty. MATERIALS AND METHODS We conducted a double-blinded randomized controlled trial comparing intravenous TXA to placebo in 60 patients undergoing primary anatomic and reverse shoulder arthroplasty. 29 patients received a placebo whilst 31 received a single dose of 2g of intravenous TXA. Patient demographics as well as drain tube output, blood loss, hematoma formation, transfusion requirement, length of hospital stay and pain scores were recorded. Patients were followed up for 12 weeks to assess for complications. RESULTS Patients who received TXA had lower drain tube outputs at all time points, 41ml compared to 133ml at 6 hours, 75ml compared to 179ml at 12 hours and 94ml compared to 226ml at 24 hours (all P<0.001). They also had higher postoperative Hb (12.3 vs 11.4; P=0.009), lower change in Hb (1.7 vs 2.3; P=0.011), lower total Hb loss (0.078g vs 0.103g; P=0.042) and blood volume loss (0.55L vs 0.74L; P=0.021), higher postoperative hematocrit (36.7 vs 34.6; P=0.020) and lower hematocrit change (5.4 vs 7.6; P=0.022). There was no significant difference in pain scores or length of hospital stay and no patients required a transfusion. CONCLUSION A single dose of 2g intravenous Tranexamic Acid decreases blood loss and drain tube output in primary anatomic and reverse arthroplasty of the shoulder. There were no differences detected in occurrence of complications, need for transfusion, pain scores or length of hospital stay. With the mounting evidence now available, patients undergoing an elective primary shoulder arthroplasty should be given intravenous TXA to decrease peri-operative blood loss.