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1.
Comparative Analysis of Hemostatic Efficacy: Local Application of Lancehead Snake Venom Thrombin versus Hemostatic Forceps in Colon Polypectomy
Chen, D., Kou, J., Zhang, J.
Alternative therapies in health and medicine. 2024
Abstract
BACKGROUND Colon polypectomy often involves managing bleeding, and the choice of hemostatic methods is critical for patient outcomes. This study addresses the hemostatic effects of lancehead snake venom thrombin compared to hemostatic forceps in the context of colon polypectomy. OBJECTIVE To compare and assess the effectiveness and safety of local application of lancehead snake venom thrombin and hemostatic forceps in achieving hemostasis during colon polypectomy. DESIGN A randomized controlled trial was conducted to investigate and compare the hemostatic outcomes of two different approaches in colon polypectomy. SETTING The study was conducted at the Affiliated Hospital of Hebei University Hospital from January 2022 to June 2022. PARTICIPANTS A total of 80 patients with colon polyps who met the inclusion criteria were randomly assigned to either the lancehead snake venom thrombin group or the hemostatic forceps group. INTERVENTIONS In the hemostatic forceps group, hemostatic forceps were employed to seal the wound post-polyp resection. In the lancehead snake venom thrombin group, aluminium potassium sulfate gel, in conjunction with locally sprayed lancehead snake venom thrombin, was applied to the wound. PRIMARY OUTCOME MEASURES The study assessed (1) intraoperative immediate bleeding and hemostasis; (2) intraoperative hemostasis time; (3) postoperative delayed post-polypectomy bleeding (DPPB); and (4) adverse reactions as primary outcome measures. RESULTS No significant differences were observed in the incidence rate of intraoperative immediate bleeding and the success rate of intraoperative hemostasis between the two groups. The lancehead snake venom thrombin group exhibited a shorter intraoperative hemostasis time and a lower incidence rate of adverse reactions compared to the hemostatic forceps group. No significant difference was found in the incidence rate of postoperative DPPB between the two groups. CONCLUSION Local application of lancehead snake venom thrombin proves to be more effective and safer than hemostatic forceps in promptly managing bleeding during colon polypectomy.
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The effect of the use of tranexamic acid in percutaneous nephrolithotomy on blood loss and surgical visual clarity: a prospective, randomized, controlled and double-blind study
Caliskan, B., Sinan, H., Çağlar, U., Şen, Ö, Akbulut, M. F.
Urolithiasis. 2024;52(1):20
Abstract
Tranexamic acid, once a randomly used antifibrinolytic agent, has been in standard protocols for many specific surgeries. Studies are still needed to standardize the dose and route of tranexamic acid administration, examine its possible contributions in urological surgery, and establish a protocol for its use. To contribute to this goal, we designed a prospective, randomized, double-blind study on 75 patients with 1 control and 2 study groups (n = 25) who underwent percutaneous nephrolithotomy. Group Tranexamic acid received 10 mg/kg intravenous tranexamic acid preoperatively. And Group Irrigation received the same amount in the initial irrigation fluid. Primarily, we observed the total amount of blood transfusion and the changes in hemoglobin and hematocrit values during 2 postoperative days. Distinctively, we intraoperatively monitored hemoglobin continuously as a saturation hemoglobin value to assess the timing of the effect of tranexamic acid. Secondarily, we questioned surgical visual clarity with a standard visual score to reveal its contribution to surgical practicality, operative time, and residual fragment quantity. Our results revealed a significant difference in the reduction of hemoglobin and hematocrit change and blood transfusion in both tranexamic acid groups concerning control, especially on the second day (p = 0.003, p = 0.002, p = 0.001). Likewise, surgical visual scores were significantly better in both tranexamic acid groups (p = 0.018). In conclusion, intravenous or local administration of tranexamic acid at a dose of 10 mg/kg will be sufficient to maintain perioperative stability in hemoglobin values, use fewer blood products and provide a better visual advantage for the surgeon intraoperatively.The trial registration number is NCT05947435, and the date of registration is 07/07/2023, retrospectively registered.
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Comparison of 1-day versus 3-day intravenous terlipressin in cirrhosis patients with variceal bleeding: A pilot randomised controlled trial
Vaishnav, M., Biswas, S., Shenoy, A., Pathak, P., Anand, A., Swaroop, S., Aggrawal, A., Arora, U., Elhence, A., Jagannath, S., et al
Alimentary pharmacology & therapeutics. 2024
Abstract
BACKGROUND In cirrhosis patients with acute variceal bleeding (AVB), the optimal duration of vasoconstrictor therapy after endoscopic haemostasis is unclear. AIMS We aimed to compare efficacy of 1-day versus 3-day terlipressin therapy in cirrhosis patients with AVB post-endoscopic intervention. The primary objective was to compare rebleeding at 5 days between the two arms. Secondary objectives included rebleeding and mortality rates at 6 weeks. METHODS In this open-label, randomised controlled trial, cirrhosis patients with AVB were randomised to either 1-day or 3-day terlipressin therapy. RESULTS A total of 150 cirrhosis patients with AVB were recruited to receive either 1 day (n = 75) or 3 days (n = 75) of terlipressin therapy. One patient from 1-day arm was excluded. Modified intention-to-treat analysis included 149 patients. Baseline characteristics were comparable between the two groups. Rebleeding at 5 days: 3 (4.1%; 95% confidence interval [CI]: 0.4-9.0) versus 4 (5.3%; 95% CI: 2.0-10.0), risk difference (RD) p = 0.726 and 5-day mortality rates: 1 (1.4%; 95% CI: 0-7.3) versus 1 (1.3%; 95% CI: 0.2-7.0), RD p = 0.960 were similar. Rebleeding at 42 days: 9 (12.2%; 95% CI: 7.0-20.0) versus 10 (13.3%; 95% CI: 7.0-20.0), RD p = 0.842 and mortality at 42 days: 5 (6.8%; 95% CI: 3.0-10.0) versus 4 (5.3%; 95% CI: 2.0-10.0), RD p = 0.704 were also similar. Patients in the 1-day terlipressin therapy arm experienced significantly fewer adverse effects compared with those receiving 3 days of terlipressin therapy: 28 (37.8%) versus 42 (56%), p = 0.026. CONCLUSIONS Our results suggest that 1 day of terlipressin therapy is associated with similar 5-day and 42-day rebleeding rates, 42-day mortality and an overall superior safety profile compared with 3-day of terlipressin therapy. These findings require to be validated in double-blinded, larger, multiethnic and multicentre studies across the various stages of cirrhosis (CTRI/2019/10/021771).
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Temporary Portocaval Shunt Provides Superior Intra-operative Hemodynamics and Reduces Blood Loss and Duration of Surgery in Live Donor Liver Transplantation: A Randomized Control Trial
Yl, M. K., Patil, N. S., Mohapatra, N., Sindwani, G., Dhingra, U., Yadav, A., Kale, P., Pamecha, V.
Annals of surgery. 2024
Abstract
OBJECTIVE The primary objectives were to compare intra operative hemodynamic parameters, blood loss, renal function, and duration of surgery with and without TPCS in live donor liver transplantation (LDLT) recipients. Secondary objectives were post-operative early graft dysfunction (EGD), morbidity, mortality, total ICU and hospital stay. BACKGROUND Blood loss during recipient hepatectomy for liver transplantation (LT) remains a major concern. Routine use of temporary portocaval shunt (TPCS) during LT is not yet elucidated. METHODS A single centre, open label, randomized control trial. The sample size was calculated based on intraoperative blood loss. After exclusion, a total of 60 patients, 30 in each arm (TPCS versus no TPCS) were recruited in the trial. RESULTS The baseline recipient and donor characteristics were comparable between the groups. The median intra-operative blood loss (P = 0.004) and blood product transfusions (P<0.05) were significantly less in TPCS group. TPCS group had significantly improved intraoperative hemodynamics in anhepatic phase as compared to no-TPCS group (P<0.0001), requiring significantly less vasopressor support. This led to significantly better renal function as evidenced by higher intraoperative urine output in TPCS group (P=0.002). Because of technical simplicity, TPCS group had significantly fewer IVC injuries (3.3 vs. 26.7%, P=0.026) and substantially shorter hepatectomy time and total duration of surgery (529.4 ± 35.54 vs. 606.83 ± 48.13 mins, P<0.0001). ). Time taken for normalisation of lactate in the immediate post-operative period was significantly shorter in TPCS group (median, 6 h vs. 13 h; P=0.04). Although post-operative endotoxemia, major morbidity, 90day mortality, total ICU and hospital stay were comparable between both the groups, tolerance to enteral feed was earlier in the TPCS group. CONCLUSION In LDLT, TPCS is a simple and effective technique that provides superior intraoperative hemodynamics and reduces blood loss and duration of surgery.
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Full Correction of Posttransplant Anemia Is Associated With Stabilized Cardiac Dimensions Among Kidney Transplant Recipients: A Prospective Randomized Controlled Trial
Al-Otaibi, T., Nagib, A. M., Halim, M. A., Abo-Atya, H., Mahmoud, T., Nair, P., Adel, H., Mosaad, A., Fathy, A., Abdul-Hameed, M., et al
Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation. 2024;22(Suppl 1):323-331
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Editor's Choice
Abstract
OBJECTIVES Posttransplant anemia might be associated with cardiovascular morbidity and increased mortality. To our knowledge, the debate on anemia correction has neither been revisited nor decided definitively. We aimed to assess the effects of full correction of posttransplant anemia on the cardiovascular system and quality of life among renal transplant recipients with stable graft function who were using erythropoietin-stimulating agents. MATERIALS AND METHODS We enrolled 247 kidney recipients with stable graft function to be assessed for anemia. Eligible patients were randomized to achieve targeted hemoglobin of 11 to 12 g/dL (group 1, n = 183) or of 13 to 15 g/dL (group 2, n = 64) with the use of erythropoietin-stimulating agents. Patients underwent monthly clinical and laboratory evaluations of kidney graft function. Quality of life and echocardiography were assessed at study start and at 12 months. RESULTS The 2 groups were comparable regarding pretransplant characteristics. In group 2, we observed comparable posttransplant complications (P > .05) but better graft function at 6 months and better cardiac indexes at 1 year of the study (P < .05). At 12 months, quality of life had improved after full correction of posttransplant anemia in the renal transplant recipients who received erythropoietinstimulating agents. CONCLUSIONS Full correction of posttransplant anemia in renal transplant recipients was associated with improved quality of life and cardiac indexes without an effect on cardiovascular comorbidity.
PICO Summary
Population
Adult kidney transplant recipients with stable graft function (n= 247).
Intervention
Targeted haemoglobin of 11 to 12 g/dL with the use of erythropoietin-stimulating agents (ESA) (group 1, n= 183)
Comparison
Targeted haemoglobin of 13 to 15 g/dL with ESA (group 2, n= 64)
Outcome
Patients underwent monthly clinical and laboratory evaluations of kidney graft function. Quality of life and echocardiography were assessed at study start and at 12 months. In group 2, there were comparable post-transplant complications, but better graft function at 6 months and better cardiac indexes at 1 year of the study. At 12 months, quality of life had improved after full correction of post-transplant anaemia in the renal transplant recipients who received erythropoietin-stimulating agents.
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Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial
Serradilla-Martin M, Paterna-Lopez S, Palomares-Cano A, Cantalejo-Diaz M, Abadia-Forcen T, Gutierrez-Diez ML, Artigas-Marco C, Serrablo-Requejo A
BJS open. 2023;7(2)
Abstract
BACKGROUND The potential of haemostatic patches to reduce the rate of postoperative pancreatic fistula remains unclear. The aim of this trial was to evaluate the impact of a polyethylene glycol-coated haemostatic patch on the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy. METHODS In this randomized, single-centre, clinical trial, patients undergoing pancreatoduodenectomy were randomized 1 : 1 to receive pancreatojejunostomy reinforced with two polyethylene glycol-coated haemostatic patches (patch group) or without any reinforcement (control group). The primary outcome was clinically relevant postoperative pancreatic fistula, defined as grade B/C according to International Study Group of Pancreatic Surgery criteria, within 90 days. Key secondary outcomes were length of hospital stay, total rate of postoperative pancreatic fistula, and overall complication rate. RESULTS From 15 May 2018 to 22 June 2020, 72 patients were randomized, and 64 were included in the analyses (31 in the patch group and 33 in the control group). The risk of clinically relevant postoperative pancreatic fistula was reduced by 90 per cent (OR 0.10, 95 per cent c.i. 0.01 to 0.89, P = 0.039). Moreover, the use of the polyethylene glycol-coated patch retained its protective effect on clinically relevant postoperative pancreatic fistula in a multivariable regression model, significantly reducing the risk of clinically relevant postoperative pancreatic fistula by 93 per cent (OR 0.07, 95 per cent c.i. 0.01 to 0.67, P = 0.021), regardless of patient age, sex, or fistula risk score. The incidence of secondary outcomes did not significantly differ between the groups. One patient died within 90 days in the patch group versus three patients in the control group. CONCLUSIONS A polyethylene glycol-coated haemostatic patch reduced the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy. REGISTRATION NUMBER NCT03419676 (http://www.clinicaltrials.gov).
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Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial
Martel, G., Lenet, T., Wherrett, C., Carrier, F. M., Monette, L., Workneh, A., Brousseau, K., Ruel, M., Chassé, M., Collin, Y., et al
Trials. 2023;24(1):38
Abstract
INTRODUCTION Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. METHODS This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. TRIAL REGISTRATION ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.
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Analysis of Hemostatic Effect and Safety of Local Spray Treatment With Hemocoagulase Bothrops Atrox for Injection After Resection of Colon Polyps
Chen, D., Chen, Y., Wang, M.
Alternative therapies in health and medicine. 2023
Abstract
CONTEXT Postoperative bleeding after resection of colon polyps (CPs) is an extremely common adverse event with endoscopic treatment. Hemocoagulase Bothrops Atrox (HBA) is a newly discovered hemostatic substance that contains thrombin-like and coagulation kinase-like enzymes. However, research is lacking about its use for the treatment of intestinal polyps. OBJECTIVE The study intended to examine the hemostatic efficacy and safety of a local spray treatment with HBA, derived from HBA for injection, after CP resection, to provide a new hemostatic method, support HBA's use, and provide evidence for clinical decision making. DESIGN The research team performed a randomized controlled study. SETTING The study took place at the Affiliated Hospital of Hebei University in Baoding, Hebei, China. PARTICIPANTS Participants were 200 patients with CP who received treatment at the hospital between December 2020 and December 2022. INTERVENTION The research team divided participants into two groups with 100 participants each, an intervention group and a control group, using the random number expression method. For hemostasis, the intervention group received a local spray treatment that used HBA for injection, and the control group received metal-clip closure or electrocoagulation. OUTCOME MEASURES The research team measured: (1) the hemostatic efficacy; (2) clinical outcomes-time to hemostasis, hemostasis rate, rebleeding rate, and incidence of late postoperative bleeding; (3) at baseline and at 24h postintervention, the coagulation function-prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB); (4) at baseline and at 24h postintervention, PLT parameters-platelet count (PLT), procalcitonin (PCT), and mean platelet volume (MPV); (5) economic effects-total number of participants with hemostasis, hospital days, and total hospital costs; and (6) adverse reactions. RESULTS The total hemostatic efficacy for the intervention group was significantly higher than that of the control group (P = .027), and the time to hemostasis was significantly shorter (P < .001) and the hemostasis rate, rebleeding rate, and incidence of late postoperative bleeding were all significantly lower than those of the control group, at P = .009, P = .009, and P = .048, respectively. In addition, the intervention group's postoperative PT, TT, APTT, FIB, and MPV were all significantly lower than those of the control group (all P < .05), while its PLT and PCT were significantly higher than those of the control group (both P < .05). The intervention group's total number of participants with hemostasis, participants with hemostasis, hospital days, and total cost were significantly lower than those of the control group (all P < .05), while no significant difference existed between the groups in the incidence of adverse effects (P > .05). CONCLUSIONS HBA has an excellent hemostatic effect on intestinal polypectomy, with convenient use and high safety. In the future, popularizing the use of HBA in the treatment of intestinal polypectomy can not only effectively guarantee the postoperative safety of patients but also could reduce their economic burden and improve the quality of clinical medical services.
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Precise Application of Topical Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding: A Randomized Controlled Study
Chiang, H. C., Chen, P. J., Yang, E. H., Hsieh, M. T., Shih, I. C., Cheng, H. C., Chang, W. L., Chen, W. Y., Chiu, H. C., Kuo, H. Y., et al
Gastrointestinal endoscopy. 2023
Abstract
BACKGROUND AND AIMS Peptic ulcer rebleeding occurs in 20% to 30% of patients after standard endoscopic hemostasis, particularly within 4 days after the procedure. The application of additional tranexamic acid (TXA) to the ulcer may enhance hemostasis. This study investigated the effectiveness of TXA powder application on bleeding ulcers during endoscopic hemostasis. METHODS This study enrolled patients who had peptic ulcer bleeding between March 2022 and February 2023. After undergoing standard endoscopic therapy, the patients were randomly assigned to either a TXA group or standard group. In the TXA group, an additional 1.25 g of TXA powder was sprayed endoscopically on the ulcer. Both groups then received 3 days of high-dose, (8 mg/h) continuous infusion proton-pump inhibitor therapy. Second-look endoscopy was conducted on days 3 to 4. The primary endpoint of early treatment failure was defined as ulcer rebleeding within 4 days or major stigmata of recent hemorrhage on the second-look endoscopy. RESULTS Sixty patients (30 in each group) with peptic ulcer bleeding and balanced baseline characteristics were randomly assigned to treatment groups. The early treatment failure rate was lower in the TXA group (6.7%) than in the standard group (30%) (P = .042). The freedom from treatment failure periods for 4 and 28 days were significantly longer in the TXA group than in the standard group (P = .023). No adverse events from TXA were recorded. CONCLUSION The precise delivery of topical TXA alongside standard endoscopic hemostasis reduced the early treatment failure rate in patients with bleeding peptic ulcers.
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A randomized controlled trial of propranolol use during ligation program for secondary prophylaxis of esophageal variceal bleeding
Chen, W. C., Yang, T. C., Lee, P. C., Wang, Y. P., Hou, M. C., Lee, F. Y.
The American journal of gastroenterology. 2023
Abstract
INTRODUCTION Endoscopic variceal ligation (EVL) plus non-selective beta-blockers (NSBBs) is the standard of care for secondary prophylaxis of esophageal variceal bleeding (EVB). This trial aimed to compare the rebleeding rates between EVL plus NSBBs till eradication of esophageal varices (EEV) and EVL plus long-term NSBBs. METHODS After control of acute EVB, patients with cirrhosis were randomized to two groups, with Group A patients receiving EVL plus propranolol till EEV, while Group B patients received standard of care with continuation of propranolol. Recurrent varices were ligated at follow-up endoscopy in both groups. RESULTS The median follow-up period was 23.0 months in Group A (n = 106) and 23.6 months in Group B (n = 106). Twelve patients (11.3%) in Group A and 11 (10.4%) in Group B had recurrent EVB. The difference in rebleeding rates and the 95% confidence interval (CI) was 0.9% (-7.5%, 9.3%). The upper 95% CI bound of the difference was within the margin of 13.2% and the non-inferiority of Group A to Group B was established. Thirty-eight patients (35.8%) in Group A and 40 (37.7%) in Group B had further decompensation, with the difference (95% CI) of -1.9% (-14.9%, 11.1%). Twenty-four patients (22.6%) in Group A and 26 (24.5%) in Group B expired, with the difference (95% CI) in mortality rates of -1.9% (-13.3%, 9.5%). DISCUSSION EVL plus propranolol till EEV was non-inferior to EVL plus continuing propranolol in secondary prophylaxis of EVB but the impact on further decompensation and transplantation-free survival deserved further investigation.