Comparison of TC-325 Hemostatic Powder with Standard Endoscopic Treatments for Malignancy-Related Upper Gastrointestinal Bleeding: Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: TC-325 powder has been successfully used in the management of malignancy-related upper gastrointestinal bleeding (UGIB) with favorable results. We conducted a meta-analysis of randomized controlled trials (RCTs) comparing TC-325 hemostatic powder with standard endoscopic treatments in the management of malignancy-related UGIB. METHODS: Several databases were reviewed from inception to May 02, 2024 to identify RCTs comparing TC-325 and standard endoscopic treatments for the management of malignancy-related UGIB. Our outcomes of interest were immediate hemostasis, 30-day rebleeding, length of hospital stay, need for surgery, need for angiographic embolization, and all-cause mortality. We calculated pooled risk ratio (RR) with 95% confidence intervals (CI) for categorical variables and mean difference (MD) with 95% CI for continuous variables. We used a random effect model to analyze the data and heterogeneity was assessed by I2 statistic. RESULTS: Four RCTs with 227 patients were included. We found that, the rate of immediate hemostasis was significantly higher in the TC-325 group compared to the standard therapy group, RR (95% CI): 1.48 (1.26, 1.74). There was no significant difference in 30-day rebleeding between the groups RR (95% CI): 0.52 (0.15, 1.76). We found no significant difference in other outcomes between groups such as the need for angiographic embolization, all-cause mortality, length of hospital stay, and need for surgery. CONCLUSIONS: We found that, TC-325 hemostatic powder was superior to standard endoscopic treatments in achieving immediate hemostasis in patients with malignancy-related UGIB.

Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study.

Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05). Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

Novel Use of Endoscopic Hemospray to Achieve Hemostasis in Pulmonary Hemorrhage: A Case Series.

This article presents two cases of pulmonary hemorrhage successfully managed using TC-325, a novel hemostatic powder commonly known as Hemospray. Originally approved for endoscopic hemostasis in gastrointestinal bleeding, Hemospray's application in endobronchial bleeding control has not been widely reported. The cases highlight its efficacy in achieving immediate and sustained hemostasis in peripheral pulmonary bleeding, where conventional bronchoscopic therapies may be ineffective. The absence of adverse effects and the rapid cessation of bleeding underscore the potential of Hemospray as a valuable tool in the bronchoscopist's arsenal, especially in life-threatening hemoptysis scenarios. The ease of application and quick hemostatic effects position Hemospray as a pragmatic solution for cases with challenging bleeding sources. While further studies are warranted to validate its efficacy and safety in a larger cohort, these cases advocate for considering Hemospray as a potential game-changer in the comprehensive management of hemoptysis, addressing limitations or risks associated with conventional interventions.

Hemospray Versus Conventional Therapy for Non-variceal Upper Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

Hemospray (TC-325; Cook Medical, Winston-Salem, NC) has been used effectively in hemostasis in non-variceal upper gastrointestinal (GI) bleeding. Current guidelines suggest using Hemospray as a temporizing measure or adjunct technique. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Hemospray as a modality for primary hemostasis. We searched MEDLINE, CENTRAL, and CINAHL (Cumulative Index of Nursing and Allied Health Literature) databases from inception to August 1, 2022. Three independent reviewers performed a comprehensive review of all original articles describing the application of Hemospray as the primary method of hemostasis in non-variceal upper GI bleeding patients. Three reviewers independently reviewed and abstracted data and assessed study quality using the Cochrane risk of bias tool. Primary outcomes were (1) primary hemostasis rate, (2) rebleeding rate until hospital discharge or death, (3) need for surgery, and (4) overall mortality rate. Of the 211 studies identified, 146 underwent title and abstract review, and four were included in the systematic review. Pooled results from 303 patients showed that compared to standard of care, Hemospray has significantly higher odds of primary hemostasis (OR: 3.48, 95% CI: 1.09-11.18, p = 0.04). There was no statistically significant difference in terms of rebleeding rates (OR: 0.79, 95% CI: 0.24-2.55, p = 0.69), need for surgery (OR: 1.62, 95% CI: 0.35-7.41, p = 0.54), or overall mortality (OR: 1.08, 95% CI: 0.56-2.08, p = 0.83). This systematic review and meta-analysis prove that Hemospray is a better modality of primary hemostasis in non-variceal upper GI bleeding when used as a primary method. At the same time, there is no significant difference in complications, including rebleeding, need for surgical intervention, and all-cause mortality.

Hemostatic Powders in Non-Variceal Upper Gastrointestinal Bleeding: The Open Questions.

Hemostatic powder (HP) is a relatively recent addition to the arsenal of hemostatic endoscopic procedures (HEPs) for gastrointestinal bleeding (GIB) due to benign and malignant lesions. Five types of HP are currently available: TC-325 (Hemospray™), EndoClot™, Ankaferd Blood Stopper®, and, more recently, UI-EWD (NexpowderTM) and CEGP-003 (CGBio™). HP acts as a mechanical barrier and/or promotes platelet activation and coagulation cascade. HP may be used in combination with or as rescue therapy in case of failure of conventional HEPs (CHEPs) and also as monotherapy in large, poorly accessible lesions with multiple bleeding sources. Although the literature on HP is abundant, randomized controlled trials are scant, and some questions remain open. While HP is highly effective in inducing immediate hemostasis in GIB, the rates of rebleeding reported in different studies are very variable, and conditions affecting the stability of hemostasis have not yet been fully elucidated. It is not established whether HP as monotherapy is appropriate in severe GIB, such as spurting peptic ulcers, or should be used only as rescue or adjunctive therapy. Finally, as it can be sprayed on large areas, HP could become the gold standard in malignancy-related GIB, which is often nonresponsive or not amenable to treatment with CHEPs as a result of multiple bleeding points and friable surfaces. This is a narrative review that provides an overview of currently available data and the open questions regarding the use of HP in the management of non-variceal upper GIB due to benign and malignant diseases.

Outcomes of Hemospray therapy in the treatment of intraprocedural upper gastrointestinal bleeding post-endoscopic therapy.

INTRODUCTION: With increasing advances in minimally invasive endoscopic therapies and endoscopic resection techniques for luminal disease, there is an increased risk of post-procedure bleeding. This can contribute to significant burden on patient's quality of life and health resources when reintervention is required. Hemospray (Cook Medical, North Carolina, USA) is a novel haemostatic powder licensed for gastrointestinal bleeding. The aim of this single-arm, prospective, non-randomised multicentre international study is to look at outcomes in patients with upper gastrointestinal bleeds following elective endoscopic therapy treated with Hemospray to achieve haemostasis. METHODS: Data was prospectively collected on the use of Hemospray from 16 centres (January 2016-November 2019). Hemospray was used during the presence of progressive intraprocedural bleeding post-endoscopic therapy as a monotherapy, dual therapy with standard haemostatic techniques or rescue therapy once standard methods had failed. Haemostasis was defined as the cessation of bleeding within 5 min of the application of Hemospray. Re-bleeding was defined as a sustained drop in haemoglobin (>2 g/l), haematemesis or melaena with haemodynamic instability after the index endoscopy. RESULTS: A total of 73 patients were analysed with bleeding post-endoscopic therapy. The median Blatchford score at baseline was five (interquartile range 0-9). The median Rockall score was six (interquartile range 5-7). Immediate haemostasis following the application of Hemospray was achieved in 73/73 (100%) of patients. Two out of 57 (4%) had a re-bleed post-Hemospray, one was following oesophageal endoscopic mucosal resection and the other post-duodenal endoscopic mucosal resection. Both patients had a repeat endoscopy and therapy within 24 h. Re-bleeding data was missing for 16 patients, and mortality data was missing for 14 patients. There were no adverse events recorded in association with the use of Hemospray. CONCLUSION: Hemospray is safe and effective in achieving immediate haemostasis following uncontrolled and progressive intraprocedural blood loss post-endoscopic therapy, with a low re-bleed rate.

High rate of re-bleeding after application of Hemospray for upper and lower gastrointestinal bleeds.

BACKGROUND & AIMS: Hemospray (TC-325, Cook Medical) has recently been approved for use in GI bleeding. Specific clinical indications and predictors of success or failure have not been well delineated. METHODS: We conducted a retrospective cohort study of Hemospray use at a tertiary center. We assessed demographics and characteristics of Hemospray use. We analyzed outcomes of hemostasis, rebleeding, need for embolization or surgery, and death. RESULTS: 86 applications of Hemospray were identified. The most common etiology of upper GI bleeds were ulcers (67.1%) whilst the etiology of lower GI bleeds varied. Hemospray was applied as monotherapy in 28 procedures (32.6%). Immediate hemostasis rate was 88.4%, but there was a high rate of re-bleeding (33.7%). Most re-bleeds occurred within 7 days (86.2%). Syncope was an independent predictive factor re-bleeding at 7 days for EGD (OR = 12.16, 95% CI = 1.51-97.75, P = 0.019). Bleeding refractory to endoscopic treatment with hemospray required radiological embolization in 9 instances, and surgery in 9 instances. Hemospray therapy was protective against need for embolization (p < 0.05). 2 patients underwent liver transplantation and there was a total of 5 deaths. Hepatic disease was an independent predictor of death (OR = 47.15, 95% CI = 2.42-916.89, P = 0.011). CONCLUSION: Hemospray is effective in achieving immediate hemostasis but is plagued by high rates of rebleeding. Syncope is a predictor of rebleeding, and hepatic disease is a predictor of death in patients undergoing Hemospray therapy. Despite high rates of embolization and surgery, Hemospray may reduce need for embolization. Hemospray use during endoscopy should prompt physicians to consider early re-look endoscopy and more aggressive therapy.

Efficacy of Hemospray in non-variceal upper gastrointestinal bleeding: a systematic review with meta-analysis.

BACKGROUND: Recently, 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. METHODS: Our 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. RESULTS: A 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. CONCLUSION: Hemospray 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.

Long-Term Effectiveness, Safety and Mortality Associated with the Use of TC-325 for Malignancy-Related Upper Gastrointestinal Bleeds: A Multicentre Retrospective Study.

BACKGROUND AND STUDY AIMS: Malignant-related upper gastrointestinal bleeding (MRUGIB) is difficult to treat by conventional endoscopic methods. We sought to determine the efficacy, safety and mortality associated with the use of TC-325 for the treatment of MUGIB. PATIENTS AND METHODS: This is a multicentre, retrospective study at the University of Calgary and University of Ottawa performed between January 1, 2010, and July 30, 2016. TC-325 use was identified via staff polling, product order forms and endoscopic records review. Once identified, patient charts and online records were examined to identify MRUGIB cases and to assess our primary and secondary endpoints. OUTCOMES: The primary outcome was hemostasis at seven days. Secondary outcomes include immediate hemostasis, early hemostasis, hemostasis at 14 days, 30-day mortality, adverse events related to TC-325 therapy and the need for repeat endoscopic intervention, surgery or transarterial embolization. RESULTS: Twenty-five patients were identified. The median age was 62 years (interquartile range [IQR] 52.5-76), and most were male (64%). TC-325 was the primary treatment modality in 20 patients (80%). Hemostasis was 88%, 89%, 58% and 50% at 24 hours, 72 hours, 7 days and 14 days, respectively. Five patients underwent repeat endoscopy, two patients required surgical intervention, and transarterial embolization was not required. Twelve patients died by 30 days (48%). There were no complications directly attributed to the use of TC-325. CONCLUSIONS: TC-325 is effective for achieving and maintaining hemostasis in patients with malignancy-related upper gastrointestinal bleeding, and most patients do not require additional interventions. The 30-day mortality risk in this group of patients is high.

Treatment of gastrointestinal bleeding with hemostatic powder (TC-325): a multicenter study.

INTRODUCTION: Hemostatic powder (TC-325) is a new tool for treatment of gastrointestinal bleeding that allows the treatment of large surfaces with active bleeding. The aim was to describe the initial success of TC-325 for the control of GI bleeding. MATERIALS AND METHODS: We did a multicenter cohort study with patients admitted to the endoscopy service for GI bleeding. A format was generated to standardize the information obtained in each center. It was determined whether this treatment had been used as a single therapy or as a combination therapy. Descriptive statistics with medians and ranges, or averages with SD according to distribution. RESULTS: Eighty-one patients with 104 endoscopic procedures were included. The median number of endoscopic procedures was 1 (1-3). In the first procedure, the initial success rate was 98.8% (n = 80), failure rate was 1.2% (n = 1), and rebleeding rate was 20% (n = 16). The majority of rebleeding cases occurred within the first 3 days (12/16, 75%). There was no association between rebleeding and etiology (malignant or benign; P = 0.6). In first procedure, 44 (54%) cases had monotherapy with TC-325 and 37 (46%) cases had a combined endoscopic therapy. There were no differences in initial success or rebleeding rates when TC-325 was used as monotherapy versus combined therapy (P = 0.7). The mortality rate was 4% (3/81). CONCLUSION: TC-325 is effective for achieving initial control of bleeding in patients with different GI etiologies. The rate of bleeding recurrence is considerable in both patients with benign and malignant etiology.

TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study.

OBJECTIVE: Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding. However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT). Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata. METHODS: This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers. RESULTS: Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group. TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer. Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group. One patient required angio-embolization therapy while three had successful conventional endotherapy. Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related. In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding. CONCLUSIONS: Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers. Larger trials are necessary for definitive results.