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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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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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Topical hemostatic agents in the management of upper gastrointestinal bleeding: a meta-analysis
Alali AA, Moosavi S, Martel M, Almadi M, Barkun AN
Endoscopy international open. 2023;11(4):E368-e385
Abstract
Background and study aims Novel topical hemostatic agents have shown promising results in treating patients with non-variceal upper gastrointestinal bleeding (NVUGIB). However, data are limited even in published meta-analyses as to their role, especially compared to conventional endoscopic approaches. The aim of this study was to perform a highly comprehensive systematic review assessing the effectiveness of topical hemostatic agents in UGIB in different clinical settings. Methods We performed a literature search of OVID MEDLINE, EMBASE, and ISI Web of Knowledge databases through September 2021. Studies assessing the efficacy of topical hemostatic agents in UGIB were included. Main outcomes were immediate hemostasis and overall rebleeding. Results A total of 980 citations were identified and 59 studies with a total of 3,417 patients were included in the analysis. Immediate hemostasis was achieved in 93 % (91 %; 94 %), with similar results according to etiology (NVUGIB vs. variceal), topical agent used, or treatment strategy (primary vs. rescue). The overall rebleeding rate was 18 % (15%; 21 %) with the majority of rebleeds occurring in the first 7 days. Among comparative studies, topical agents achieved immediate hemostasis more often than standard endoscopic modalities (OR 3.94 [1.73; 8.96), with non-different overall rebleeding odds (OR 1.06 [0.65; 1.74]). Adverse events occurred in 2 % (1 %; 3 %). Study quality was overall low to very low. Conclusions Topical hemostatic agents are effective and safe in the management of UGIB with favorable outcomes when compared to conventional endoscopic modalities across a variety of bleeding etiologies. This is especially true in novel subgroup analyses that assessed immediate hemostasis and rebleeding among RCTs and in malignant bleeding. Due to methodological limitations of available data, additional studies are needed to ascertain their effectiveness more confidently in the management of patients with UGIB.
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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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Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial
t Hart, J. W. H., Noordman, B. J., Wijnand, J. M. A., Biter, L. U., Verbrugge, S. J. C., Birnie, E., Dunkelgrun, M., Huisbrink, J., Apers, J. A.
Surgical endoscopy. 2023;37(10):7455-7463
Abstract
INTRODUCTION In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG). METHODS In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality. RESULTS In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien-Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported. CONCLUSION This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications.
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Evaluating the Significance of Titanium Clip Marking Under Endoscopy in Upper Gastrointestinal Bleeding Patients with Failed Endoscopic Hemostasis
Zhu, J., Shi, R., Li, B., Yang, K.
Alternative therapies in health and medicine. 2023
Abstract
OBJECTIVE This study investigated the role of titanium clip marking during endoscopy in managing patients with upper gastrointestinal bleeding (UGIB) for whom endoscopic hemostasis has proven ineffective. METHODS A total of 63 UGIB patients admitted to the Affiliated Hospital of Zunyi Medical University between January 2018 and November 2020 were selected as the study cohort. Patients were randomly assigned to one of two groups: the control group (n=23) and the combined group (n=40). The control group underwent transcatheter arterial embolization (TAE), while the combined group received endoscopic metallic titanium clip-assisted TAE. This study compared the rates of successful embolization, clinical success, recurrence, operation time, radiation exposure time, radiation dosage, levels of hs-CRP, Cor, NE, TNF-α, IL-6, and ADH before and after treatment, as well as postoperative complications between the two groups. RESULTS The combined group of patients exhibited significantly higher rates of successful embolization and clinical success compared to the control group (P < .05). Additionally, the recurrence rate and levels of hs-CRP, Cor, NE, TNF-α, IL-6, and ADH were significantly lower in the combined group compared to the control group (P < .05). Furthermore, patients in the combined group had shorter operation times, reduced radiation exposure times, and lower radiation dosages compared to the control group (P < .05). There was no statistically significant difference in the occurrence of postoperative complications between the two groups (P > .05). CONCLUSIONS Using titanium clip marking during endoscopy provides valuable guidance in managing patients with upper gastrointestinal bleeding who have not responded to endoscopic hemostasis. This finding is especially relevant in digital subtraction angiography (DSA) and transcatheter arterial embolization (TAE) treatments. It enhances the clinical efficacy and safety of the procedure.
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Proton pump inhibitor has no effect in the prevention of post-endoscopic sphincterotomy delayed bleeding: a prospective randomized controlled trial
Yu, Z., He, J., Cao, R., Yang, Z., Li, B., Hong, J., Chen, Y., Zhu, L.
Frontiers in medicine. 2023;10:1179512
Abstract
BACKGROUND AND AIMS Bleeding is one of the common adverse events of endoscopic retrograde cholangiopancreatography (ERCP), which is mainly caused by endoscopic sphincterotomy (EST). At present, it remains unclear whether proton pump inhibitor (PPI) should be used to prevent post-EST bleeding. Therefore, we performed a randomized controlled trial to investigate whether PPI is effective in the prevention of post-EST delayed bleeding. METHODS Consecutive eligible patients were randomly assigned (1:1) to experimental group (PPI group) or control group (normal saline, NS group). The patients in PPI group received intravenous esomeprazole 40 mg and normal saline 100 mL every 12 h for 2 days after ERCP immediately, and followed by oral esomeprazole (Nexium) 20 mg once a day for 7 days. Correspondingly, patients in the control group received intravenous normal saline 100 mL and did not take PPIs or any acid-suppressing drugs during hospitalization and after discharge. All patients were followed up for 30 days after ERCP. The primary endpoint was the incidence and severity of post-EST delayed bleeding. RESULTS Between July 2020 and July 2022, 290 patients were randomly assigned to PPI group (n = 146) or NS group (n = 144). 5 patients from each group were excluded from the final analysis. There were 6 patients with post-EST delayed bleeding, with an incidence rate of 2.14%. The median time of delayed bleeding was 2.5 days after ERCP. 3 cases (2.12%, 3/141) occurred in the PPI group, with 1 case of mild and 2 cases of moderate bleeding. 3 cases (2.16%, 3/139) occurred in the NS group, with 2 cases of mild and 1 case of moderate bleeding. There was no significant difference in the incidence and the severity of post-EST delayed bleeding between the two groups (p = 1.000). CONCLUSION Prophylactic use of PPI after EST does not reduce the incidence and severity of post-EST delayed bleeding in patients. CLINICAL TRIAL REGISTRATION https://www.chictr.org.cn/searchproj.aspx, identifier ChiCTR2000034697.
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Efficacy of self-assembling peptide in mitigating delayed bleeding after advanced endoscopic resection of gastrointestinal lesions: A meta-analysis
Gopakumar, H., Vohra, I., Sharma, N. R., Puli, S. R.
Endoscopy international open. 2023;11(5):E553-e560
Abstract
Background and study aims Advanced endoscopic resection techniques carry a risk of delayed bleeding (DB). A novel fully synthetic self-assembling peptide (SAP) has shown promising results in mitigating this risk. In this meta-analysis, we evaluated all available data and analyzed the effectiveness of SAP in reducing DB after advanced endoscopic resection of gastrointestinal luminal lesions. Patients and methods Electronic databases (PubMed, Embase, and Cochrane Library) from January 2010 through October 2022 were searched for publications addressing the use of SAP solution in patients undergoing advanced endoscopic resection of gastrointestinal lesions. Pooled proportions were calculated using fixed (inverse variance) and random-effects (DerSimonian-Laird) models. Results The initial search identified 277 studies, of which 63 relevant articles were reviewed. The final analysis included data from six studies comprising 307 patients that met inclusion criteria. The pooled rate of DB was 5.73 % (95 % confidence interval [CI] = 3.42-8.59). Mean patient age was 69.40 years ± 1.82. The weighted mean size of resected lesions was 36.20 mm (95 % CI = 33.37-39.02). Endoscopic submucosal dissection was used in 72.69 % (95 % CI = 67.62-77.48), while endoscopic mucosal resection was used in 26.42 % (95 % CI = 21.69-31.44) of the procedures. Among the 307 patients, 36 % were on antithrombotic medications. No adverse events (AEs) were attributable to using SAP, with a pooled rate of 0.00 % (95 % CI = 0.00-1.49). Conclusions SAP solution appears promising in reducing post-procedural DB after advanced endoscopic resection of high-risk gastrointestinal lesions with no reported AEs.