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

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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Use of hemostatic powder in treatment of upper gastrointestinal bleeding: a systematic review and meta-analysis

Endoscopy International Open ◽

10.1055/a-0977-2897 ◽

2019 ◽

Vol 07 (12) ◽

pp. E1704-E1713 ◽

Cited By ~ 4

Author(s):

Daniel Tavares de Rezende ◽

Vitor Ottoboni Brunaldi ◽

Wanderley Marques Bernardo ◽

Igor Braga Ribeiro ◽

Raquel Cristina Lins Mota ◽

...

Keyword(s):

Systematic Review ◽

Gastrointestinal Bleeding ◽

Latin American ◽

Upper Gastrointestinal Bleeding ◽

Rescue Therapy ◽

Meta Analysis ◽

Secondary Outcome ◽

Primary Hemostasis ◽

Hemostatic Powder ◽

Upper Gastrointestinal

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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Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study

Endoscopy ◽

10.1055/a-0809-5276 ◽

2019 ◽

Vol 51 (05) ◽

pp. 458-462 ◽

Cited By ~ 1

Author(s):

Jin-Seok Park ◽

Byung Wook Bang ◽

Su Jin Hong ◽

Eunhye Lee ◽

Kye Sook Kwon ◽

...

Keyword(s):

Pilot Study ◽

Gastrointestinal Bleeding ◽

Success Rate ◽

Salvage Therapy ◽

Upper Gastrointestinal Bleeding ◽

Endoscopic Hemostasis ◽

High Success Rate ◽

Bleeding Site ◽

Endoscopic Procedures ◽

Upper Gastrointestinal

Abstract Background A new hemostatic adhesive powder (UI-EWD) has been developed to reduce the high re-bleeding rates associated with the currently available hemostatic powders. The current study aimed to assess the efficacy of UI-EWD as a salvage therapy for the treatment of refractory upper gastrointestinal bleeding (UGIB). Methods A total of 17 consecutive patients who had failed to achieve hemostasis with conventional endoscopic procedures and had undergone treatment with UI-EWD for endoscopic hemostasis in refractory UGIB were prospectively enrolled in the study. We evaluated the success rate of initial hemostasis and rate of re-bleeding within 30 days. Results All patients underwent successful UI-EWD application at the bleeding site. Initial hemostasis occurred in 16/17 patients (94 %). Re-bleeding within 30 days occurred in 3/16 patients (19 %) who had achieved initial hemostasis. In the second-look endoscopy after 24 hours, hydrogel from UI-EWD was found attached at the bleeding site in 11/16 patients (69 %). Conclusion UI-EWD has a high success rate for initial hemostasis in refractory UGIB and shows promising results in the prevention of re-bleeding.

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