Tu1478 NOVEL HEMOSTATIC POWDER STOPS BLEEDING IN A LIVE PROCINE MODEL OF UPPER GASTROINTESTINAL BLEEDING

Abstract Background and study aims TC-325 is a novel mineral hemostatic powder that creates a mechanical barrier by absorbing blood components and promoting clotting. Recently approved for use in humans, it has shown promise for treatment of upper gastrointestinal bleeding (UGIB). However, because there have been no large studies of TC-325, its true efficacy and safety profile remain unknown. We performed a systematic review and meta-analysis to determine the safety and efficacy of TC-325 in treating UGIB, based on rates of initial hemostasis, rebleeding, and adverse events (AEs). Methods We searched the MEDLINE/PubMed, EMBASE, CENTRAL, Latin-American and Caribbean Health Sciences Literature databases, as well as the gray literature, to identify articles describing use of TC-325 up to October 2018. Primary outcomes were initial hemostasis and rebleeding. AEs were described as a secondary outcome. Risk of bias was assessed with international scores. Results We identified 2077 records after removal of duplicates. We included 50 studies, involving a collective total of 1445 patients, in the quantitative synthesis. Primary hemostasis and rebleeding rates were 90.7 % and 26.1 %, respectively. Subgroup analyses showed similar results. Only eight AEs were reported. Conclusions TC-325 appears to be a safe, effective treatment for UGIB. The overall rate of initial hemostasis after TC-325 use is high, regardless of etiology of bleeding or whether TC-325 is used as a primary or rescue therapy. Although it is also associated with high rebleeding rates, rates of AEs and equipment failure after TC-325 use are extremely low.

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The Role of Hemostatic Powder in Endoscopic Hemostasis of Nonvariceal Upper Gastrointestinal Bleeding

Annals of Internal Medicine ◽

10.7326/m21-4267 ◽

2021 ◽

Author(s):

Alan N. Barkun ◽

Ali Alali

Keyword(s):

Gastrointestinal Bleeding ◽

Upper Gastrointestinal Bleeding ◽

Endoscopic Hemostasis ◽

Hemostatic Powder ◽

Upper Gastrointestinal

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Tu1094 THE USE OF HEMOSTATIC POWDER IN UPPER GASTROINTESTINAL BLEEDING: A SYSTEMATIC REVIEW AND META-ANALYSIS

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2019.03.1321 ◽

2019 ◽

Vol 89 (6) ◽

pp. AB553

Author(s):

Daniel T. Rezende ◽

Wanderlei M. Bernardo ◽

Vitor O. Brunaldi ◽

Igor B. Ribeiro ◽

Sérgio E. Matuguma ◽

...

Keyword(s):

Systematic Review ◽

Gastrointestinal Bleeding ◽

Upper Gastrointestinal Bleeding ◽

Meta Analysis ◽

Hemostatic Powder ◽

Upper Gastrointestinal

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A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the “GRAPHE” registry)

Endoscopy ◽

10.1055/s-0042-116148 ◽

2016 ◽

Vol 48 (12) ◽

pp. 1084-1095 ◽

Cited By ~ 49

Author(s):

Sami Haddara ◽

Jeremie Jacques ◽

Stéphane Lecleire ◽

Julien Branche ◽

Sarah Leblanc ◽

...

Keyword(s):

Gastrointestinal Bleeding ◽

Multicenter Study ◽

Upper Gastrointestinal Bleeding ◽

Hemostatic Powder ◽

Upper Gastrointestinal

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Effectiveness of the polysaccharide hemostatic powder in non-variceal upper gastrointestinal bleeding: Using propensity score matching

Journal of Gastroenterology and Hepatology ◽

10.1111/jgh.14118 ◽

2018 ◽

Vol 33 (8) ◽

pp. 1500-1506 ◽

Cited By ~ 9

Author(s):

Jun Chul Park ◽

Yeong Jin Kim ◽

Eun Hye Kim ◽

Jinae Lee ◽

Hyun Su Yang ◽

...

Keyword(s):

Propensity Score ◽

Gastrointestinal Bleeding ◽

Propensity Score Matching ◽

Upper Gastrointestinal Bleeding ◽

Hemostatic Powder ◽

Upper Gastrointestinal

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Severe upper gastrointestinal bleeding is halted by endoscopically delivered self-propelling thrombin powder: A porcine pilot study

Endoscopy International Open ◽

10.1055/a-1374-5839 ◽

2021 ◽

Vol 09 (05) ◽

pp. E693-E698

Author(s):

Nabil Ali-Mohamad ◽

Massimo Cau ◽

James Baylis ◽

Veronika Zenova ◽

Hugh Semple ◽

...

Keyword(s):

Pilot Study ◽

Gastrointestinal Bleeding ◽

Upper Gastrointestinal Bleeding ◽

Vascular Bundles ◽

Average Mass ◽

Primary Hemostasis ◽

Needle Knife ◽

Hemostatic Powder ◽

Mean Time ◽

Upper Gastrointestinal

Abstract Background and study aims Hemostatic powders have emerged recently to treat upper gastrointestinal bleeding (UGIB). Previously, we developed a novel self-propelling thrombin powder (SPTP) that effectively manages external pulsatile arterial bleed without compression, by effervescing and carrying thrombin into the wound. Here, we tested if SPTP, sprayed endoscopically, can manage severe UGIB in a live porcine model. Materials and methods Anesthetized pigs underwent laparotomy to insert the gastroepiploic vascular bundles into the stomach lumen via a gastrotomy. Bleeding was initiated endoscopically in the stomach by needle knife. SPTP was delivered to the site of bleeding from a CO2-powered spray device using a 7 FR catheter. Successful primary hemostasis, time to hemostasis, and the mass of SPTP delivered were measured. Results Hemostasis was achieved at all bleeding sites using SPTP. Mean time to hemostasis was 4.2 ± 0.9 minutes (mean ± standard error of the mean, n = 12). The average mass of SPTP delivered was 2.4 ± 0.6 g. Conclusions In this pilot study, SPTP successfully stopped 12 cases of severe UGIB, demonstrating early promise asa novel hemostatic powder.

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Randomized controlled trial of hemostatic powder versus endoscopic clipping for non-variceal upper gastrointestinal bleeding

Surgical Endoscopy ◽

10.1007/s00464-019-06769-z ◽

2019 ◽

Vol 34 (1) ◽

pp. 317-324 ◽

Cited By ~ 4

Author(s):

Felipe Iankelevich Baracat ◽

Diogo Turiani Hourneaux de Moura ◽

Vítor Ottoboni Brunaldi ◽

Caio Vinicius Tranquillini ◽

Renato Baracat ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Gastrointestinal Bleeding ◽

Upper Gastrointestinal Bleeding ◽

Controlled Trial ◽

Randomized Controlled ◽

Hemostatic Powder ◽

Endoscopic Clipping ◽

Upper Gastrointestinal

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Hemostatic powder application for control of acute upper gastrointestinal bleeding in patients with gastric malignancy

Endoscopy International Open ◽

10.1055/a-0593-5884 ◽

2018 ◽

Vol 06 (06) ◽

pp. E700-E705 ◽

Cited By ~ 6

Author(s):

Yeong Kim ◽

Jun Park ◽

Eun Kim ◽

Sung Shin ◽

Sang Lee ◽

...

Keyword(s):

Gastrointestinal Bleeding ◽

Upper Gastrointestinal Bleeding ◽

Tumor Location ◽

Short Term ◽

Modified Polymer ◽

Acute Upper Gastrointestinal Bleeding ◽

All Cause Mortality ◽

Hemostatic Powder ◽

Upper Gastrointestinal ◽

Gastric Malignancy

Abstract Background and study aims Despite use of various endoscopic therapies in patients with tumor-related bleeding, various rates of successful immediate hemostasis and short-term rebleeding have been reported. We aimed to evaluate preliminary results of use of the EndoClot polysaccharide hemostatic system (PHS) in patients with acute upper gastrointestinal bleeding (UGIB) from a gastric malignancy. Patients and methods We retrospectively analyzed data from a prospectively collected database of 12 patients with acute UGIB from a gastric malignancy who had been treated with EndoClot PHS. The EndoClot air compressor was used to propel 2 g of absorbable modified polymer particles onto the bleeding site. We checked successful immediate hemostasis, rebleeding events and mortality within 30 days. Results Twelve patients were enrolled in the study. The median patient age was 72.5 years (range, 57 – 89). The initial median hemoglobin level was 6.75 g/dL (range, 5.4 – 8.9). The median systolic blood pressure was 114 mmHg (range, 86 – 153). Eleven patients had advanced gastric cancer and one patient had a gastrointestinal stromal tumor. The lower body of the stomach was the most common tumor location (58.3 %), and the median tumor size was 40 mm (range, 15 – 100). Immediate hemostasis was achieved in all patients, and rebleeding developed in 2 of 12 patients (16 %), 3 and 5 days after treatment. There were no significant Endoclot PHS-related adverse events, and there was no all-cause mortality at 30 days after the intervention. Conclusions Endoclot PHS represents a new alternative, complementary, and promising therapy for patients with an acute UGIB from a gastric malignancy.

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