Early clinical experience of the safety and efficacy of EndoClot in the management of non-variceal upper gastrointestinal bleeding.
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ABSTRACT:
SUBMITTER: Beg S
PROVIDER: S-EPMC4683139 | biostudies-other | 2015 Dec
REPOSITORIES: biostudies-other
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Project description:Non-variceal upper gastrointestinal bleeding, the most common etiology of which is peptic ulcer disease, remains a persistent challenge despite a reduction in both its incidence and mortality. Both pharmacologic and endoscopic techniques have been developed to achieve hemostasis, with varying degrees of success. Among the pharmacologic therapies, proton pump inhibitors remain the mainstay of treatment, as they reduce the risk of rebleeding and requirement for recurrent endoscopic evaluation. Tranexamic acid, a derivative of the amino acid lysine, is an antifibrinolytic agent whose role requires further investigation before application. Endoscopically delivered pharmacotherapy, including Hemospray (Cook Medical), EndoClot (EndoClot Plus Inc.), and Ankaferd Blood Stopper (Ankaferd Health Products), in addition to standard epinephrine, show promise in this regard, although their mechanisms of action require further investigation. Non-pharmacologic endoscopic techniques use one of the following two methods to achieve hemostasis: ablation or mechanical tamponade, which may involve using endoscopic clips, cautery, argon plasma coagulation, over-the-scope clipping devices, radiofrequency ablation, and cryotherapy. This review aimed to highlight these novel and fundamental hemostatic strategies and the research supporting their efficacy.
| S-EPMC5066413 | biostudies-literature
Project description:Blood transfusion remains an integral step in the management of acute non-variceal upper gastrointestinal bleeding (NV-UGIB), but its safety is being increasingly questioned in less severe cases. The authors aimed to measure 30-day and 2-year mortalities after blood transfusion for NV-UGIB.Cox proportional hazards models were used to estimate the association of blood transfusion with mortality while adjusting for age, Charlson comorbidity score, the complete Rockall score for acute UGIB, admission status and medication intake prior to bleeding.Death from any cause at 30 days and 2 years after NV-UGIB.1340 patients presented with NV-UGIB< (808 men (60.3%), median age 67 years) of whom 564 (42.1%) were transfused. The overall mortality was 5.3% at 30 days and 26.0% at 2 years in all patients. Comparing subjects with a haemoglobin concentration greater than 10.0 g/dl who were transfused with those who were not, 30-day mortalities (95% CIs) were 11.5% (6.7 to 18.0) versus 3.6% (2.3 to 5.3), respectively, p<0.001, and 2-year mortalities (95% CIs) were 40% (32 to 49) versus 20% (17 to 23), p<0.001. After adjusting for age, Charlson score, Rockall score and haemoglobin, the HRs (95% CIs) for death after transfusion were 1.88 (1.00 to 3.55) (p=0.051) at 30 days and 1.71 (1.28 to 2.28), (p<0.001) at 2 years.In patients with moderately severe NV-UGIB, mortality is higher following blood transfusion. Whether this reflects selection bias, an effect of comorbidity or an effect of transfusion requires urgent prospective study.
| S-EPMC5517239 | biostudies-other
Project description:BackgroundRecently, amongst other hemostatic modalities, Hemospray (TC-325) has emerged as an effective method for managing patients with non-variceal upper gastrointestinal bleeding (GIB). We conducted this systematic review and meta-analysis to assess the efficacy of Hemospray in patients with non-variceal upper GIB.MethodsOur primary outcomes were clinical and technical success; secondary outcomes were aggregate rebleeding, early rebleeding, delayed rebleeding, refractory bleeding, mortality, and treatment failure. A meta-analysis of proportions was conducted for all reported primary and secondary outcomes. A relative risk meta-analysis was conducted for studies reporting direct comparisons between Hemospray and other hemostatic measures.ResultsA total of 20 studies with 1280 patients were included in the final analysis. Technical success of Hemospray was seen in 97% of cases (95% confidence interval [CI] 94-98%, I 2=52.89%) and a significant trend towards increasing technical success was seen during publication years 2011-2019. Clinical success of Hemospray was seen in 91% of cases (95%CI 88-94%, I 2=47.72%), compared to 87% (95%CI 75-94%, I 2=0.00%) for other hemostatic measures. The secondary outcomes of aggregate rebleeding, early rebleeding, delayed rebleeding, refractory rebleeding, mortality and treatment failure following the use of Hemospray were seen in 27%, 20%, 9%, 8%, 8%, and 31% of cases, respectively.ConclusionHemospray is safe, effective and non-inferior to traditional hemostatic measures for the management of non-variceal upper GIB, and can thus be used as an alternative option.
| S-EPMC7049242 | biostudies-literature
Project description:BackgroundPatients undergoing dual antiplatelet therapy (DAPT) may experience recurrent gastrointestinal bleeding (GIB). We investigated the clinical characteristics and risk factors for recurrent non-variceal upper gastrointestinal bleeding (NVUGIB) in patients who had experienced NVUGIB while receiving DAPT.MethodsWe enrolled patients diagnosed with NVUGIB while receiving DAPT between 2006 and 2020. Definite bleeding was confirmed by esophagogastroduodenoscopy in all NVUGIB patients.ResultsA total of 124 patients were diagnosed with NVUGIB while receiving DAPT. They were predominantly male (n = 103, 83.1%), bleeding mostly from the stomach (n = 94, 75.8%) and had peptic ulcers (n = 72, 58.1%). After the successful hemostasis of NVUGIB, 36 patients (29.0%) experienced at least one episode of recurrent upper GIB, 19 patients (15.3%) died, and 7 (5.6%) patients had a bleeding-related death. Multivariate analysis showed that age was a significant factor for re-bleeding (odds ratio [OR], 1.050; 95% confidence interval [CI]: 1.001-1.102; p-value: 0.047), all-cause mortality (OR, 1.096; 95% CI: 1.020-1.178, p = 0.013), and re-bleeding-related mortality (OR, 1.187; 95% CI: 1.032-1.364, p-value: 0.016). In Kaplan-Meier analysis, the cumulative probabilities of re-bleeding, death, and bleeding-related death were significantly higher in patients aged 70 and older (p = 0.008, <0.001, and 0.009, respectively).ConclusionsClinicians should be cautious about re-bleeding and mortality in elderly patients who experience NVUGIB while receiving DAPT.
| S-EPMC10670490 | biostudies-literature
Project description:BackgroundNon-variceal upper gastro-intestinal bleeding (NVUGIB) is a common and challenging emergency situation. We aimed to describe the characteristics and clinical outcomes of patients with NVUGIB in Greece.MethodsENERGIB (NCT00797641) was an epidemiological survey conducted in 7 European countries including Greece. It included adult patients with overt NVUGIB from 10 tertiary hospitals across Greece. Data for each patient were collected on admission and up to 30 days thereafter.Results201 patients were enrolled. A previous history of NVUGIB was reported by 14% of patients, while 61% had ≥ 1 co-morbidities. At presentation, 59% were on therapy that could harm the gastrointestinal mucosa, 14% on anticoagulant(s) and 42% had sign(s) of hemodynamic instability. 54% of patients showed stigmata of recent hemorrhage. Therapeutic endoscopy was performed in 25% and blood product(s) transfusions were required in 86% of cases. Proton pump inhibitors were administered before and after endoscopy in 70% and 95% of patients, respectively. Uncontrolled bleeding or rebleeding was observed in 11% being more common in elderly, hospitalized patients and patients with ≥1 co-morbidities. Second-look endoscopy was performed in 20%, angiographic intervention in 1.5% and surgical intervention in 4% of patients. Only 5/201 (2.5%) patients died during hospitalization and none died during the 30-day post-hospitalization period.ConclusionsThe majority of patients with NVUGIB in tertiary Greek hospitals are elderly, with co-morbidities, hemodynamic instability and required transfusion(s), while one fourth undergoes therapeutic endoscopic interventions. However, NVUGIB is associated with moderate degrees of continued bleeding/re-bleeding, low surgical rates and, most importantly, low mortality.
| S-EPMC3959428 | biostudies-literature
Project description:IntroductionThis study aims to construct a mortality prediction model for patients with non-variceal upper gastrointestinal bleeding (NVUGIB) in the intensive care unit (ICU), employing advanced machine learning algorithms. The goal is to identify high-risk populations early, contributing to a deeper understanding of patients with NVUGIB in the ICU.MethodsWe extracted NVUGIB data from the Medical Information Mart for Intensive Care IV (MIMIC-IV, v.2.2) database spanning from 2008 to 2019. Feature selection was conducted through LASSO regression, followed by training models using 11 machine learning methods. The best model was chosen based on the area under the curve (AUC). Subsequently, Shapley additive explanations (SHAP) was employed to elucidate how each factor influenced the model. Finally, a case was randomly selected, and the model was utilized to predict its mortality, demonstrating the practical application of the developed model.ResultsIn total, 2716 patients with NVUGIB were deemed eligible for participation. Following selection, 30 out of a total of 64 clinical parameters collected on day 1 after ICU admission remained associated with prognosis and were utilized for developing machine learning models. Among the 11 constructed models, the Gradient Boosting Decision Tree (GBDT) model demonstrated the best performance, achieving an AUC of 0.853 and an accuracy of 0.839 in the validation cohort. Feature importance analysis highlighted that shock, Glasgow Coma Scale (GCS), renal disease, age, albumin, and alanine aminotransferase (ALP) were the top six features of the GBDT model with the most significant impact. Furthermore, SHAP force analysis illustrated how the constructed model visualized the individualized prediction of death.ConclusionsPatient data from the MIMIC database were leveraged to develop a robust prognostic model for patients with NVUGIB in the ICU. The analysis using SHAP also assisted clinicians in gaining a deeper understanding of the disease.
| S-EPMC11365121 | biostudies-literature
Project description:BackgroundNon-alcoholic fatty liver disease (NAFLD) is the leading cause of liver disease globally with an estimated prevalence of 25%, with the clinical and economic burden expected to continue to increase. In the United States, non-variceal upper gastrointestinal bleeding (NVUGIB) has an estimated incidence of 61-78 cases per 100000 people with a mortality rate of 2%-15% based on co-morbidity burden.AimTo identify the outcomes of NVUGIB in NAFLD hospitalizations in the United States.MethodsWe utilized the National Inpatient Sample from 2016-2019 to identify all NVUGIB hospitalizations in the United States. This population was divided based on the presence and absence of NAFLD. Hospitalization characteristics, outcomes and complications were compared.ResultsThe total number of hospitalizations for NVUGIB was 799785, of which 6% were found to have NAFLD. NAFLD and GIB was, on average, more common in younger patients, females, and Hispanics than GIB without NAFLD. Interestingly, GIB was less common amongst blacks with NAFLD. Multivariate logistic regression analysis was conducted, controlling for the multiple covariates. The primary outcome of interest, mortality, was found to be significantly higher in patients with NAFLD and GIB [adjusted odds ratio (aOR) = 1.018 (1.013-1.022)]. Secondary outcomes of interest, shock [aOR = 1.015 (1.008-1.022)], acute respiratory failure [aOR = 1.01 (1.005-1.015)] and acute liver failure [aOR = 1.016 (1.013-1.019)] were all more likely to occur in this cohort. Patients with NAFLD were also more likely to incur higher total hospital charges (THC) [$2148 ($1677-$2618)]; however, were less likely to have a longer length of stay [0.27 d (0.17-0.38)]. Interestingly, in our study, the patients with NAFLD were less likely to suffer from acute myocardial infarction [aOR = 0.992 (0.989-0.995)]. Patients with NAFLD were not more likely to suffer acute kidney injury, sepsis, blood transfusion, intubation, or dialysis.ConclusionNVUGIB in NAFLD hospitalizations had higher inpatient mortality, THC, and complications such as shock, acute respiratory failure, and acute liver failure compared to those without NAFLD.
| S-EPMC9896500 | biostudies-literature
Project description:BackgroundIt is unclear whether an upper gastrointestinal bleed is an isolated gastrointestinal event or an indicator of a deterioration in a patient's overall health status. Therefore, we investigated the excess causes of death in individuals after a non-variceal bleed compared with deaths in a matched sample of the general population.Methods and findingsLinked longitudinal data from the English Hospital Episodes Statistics (HES) data, General Practice Research Database (GPRD), and Office of National Statistics death register were used to define a cohort of non-variceal bleeds between 1997 and 2010. Controls were matched at the start of the study by age, sex, practice, and year. The excess risk of each cause of death in the 5 years subsequent to a bleed was then calculated whilst adjusting for competing risks using cumulative incidence functions. 16,355 patients with a non-variceal upper gastrointestinal bleed were matched to 81,523 controls. The total 5-year risk of death due to gastrointestinal causes (malignant or non-malignant) ranged from 3.6% (≤ 50 years, 95% CI 3.0%-4.3%) to 15.2% (≥ 80 years, 14.2%-16.3%), representing an excess over controls of between 3.6% (3.0%-4.2%) and 13.4% (12.4%-14.5%), respectively. In contrast the total 5-year risk of death due to non-gastrointestinal causes ranged from 4.1% (≤ 50 years, 3.4%-4.8%) to 46.6% (≥ 80 years, 45.2%-48.1%), representing an excess over controls of between 3.8% (3.1%-4.5%) and 19.0% (17.5%-20.6%), respectively. The main limitation of this study was potential misclassification of the exposure and outcome; however, we sought to minimise this by using information derived across multiple linked datasets.ConclusionsDeaths from all causes were increased following an upper gastrointestinal bleed compared to matched controls, and over half the excess risk of death was due to seemingly unrelated co-morbidity. A non-variceal bleed may therefore warrant a careful assessment of co-morbid illness seemingly unrelated to the bleed.
| S-EPMC3640094 | biostudies-literature
Project description:BackgroundOur primary and secondary aims were to analyze the evidence surrounding mortality and re-bleeding risks in patients on aspirin with non-variceal upper gastrointestinal bleeding (NVUGIB) as a function of whether or not aspirin was resumed after the bleeding episode, and to determine whether aspirin intake upon admission affected the outcomes.MethodsA search for randomized controlled trials (RCTs) and prospective observational studies was performed. Data extraction and risk of bias assessment were done. Generic inverse variance and random-effects model were employed. Heterogeneity across studies was assessed using the I 2 test. Certainty of evidence was assessed using the GRADE approach for each comparison and outcome, and an evidence profile was created.ResultsEvidence from 1 RCT and 4 observational studies suggests that early aspirin resumption reduced mortality (hazard ratio [HR] 0.20, 95% confidence interval [CI] 0.06-0.63) while increasing re-bleeding risk (HR 1.90, 95%CI 0.60-6.00); moderate certainty of evidence. The observational evidence was inconsistent for both mortality (HR 0.84, 95%CI 0.54-1.33) and re-bleeding (HR 0.85, 95%CI 0.47-1.55); very low certainty of evidence. Nine observational studies addressed our secondary aim: 6 provided inconsistent results regarding mortality (pooled odds ratio [OR] 1.1, 95%CI 0.80-1.50) and 4 provided inconsistent results regarding re-bleeding risk (pooled OR 0.92, 95%CI 0.53-1.59); very low certainty of evidence for both outcomes.ConclusionEvidence supporting a protective effect of aspirin resumption soon after NVUGIB is of low-to-moderate certainty, and is not informative as to the optimal timing of aspirin resumption.
| S-EPMC8079865 | biostudies-literature
Project description:BackgroundHigh-dose proton pump inhibitor (PPI) therapy, given either intermittently or continuously for non-variceal upper gastrointestinal bleeding (NV-UGIB), is efficacious. Using intermittent PPI for low-risk patients may be cost-saving. Our objective was to estimate the annual cost savings if all low-risk NV-UGIB patients received intermittent PPI therapy.MethodsPatients who presented to hospital in Calgary, Alberta, who received a PPI for NV-UGIB from July 2015 to March 2017 were identified using ICD-10 codes. Patients were stratified into no endoscopy, high-risk, and low-risk lesion groups and further subdivided into no PPI, oral PPI, intermittent intravenous (IV), and continuous IV subgroups. Average length of stay (LOS) in each subgroup and costs were calculated.ResultsWe identified 4141 patients with NV-UGIBs, (median age 61, 57.4% male). One-thousand two-hundred and thirty-one low-risk patients received continuous IV PPI, with an average LOS of 6.8 days (95% CI 6.2-7.3) versus 4.9 days (95% CI 3.9-5.9) for intermittent IV patients. If continuous IV PPI patients instead received intermittent IV PPI, 3852 patient days and CAD 11,714,390 (2017 CAD)/year could be saved.ConclusionsUsing real-world administrative data, we demonstrate that a sizable portion of low-risk patients with NV-UGIB who were given continuous IV PPI if switched to intermittent IV therapy could generate significant potential cost savings.
| S-EPMC10384205 | biostudies-literature