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

Ramírez-Polo, A.I.; Casal-Sánchez, Jorge; Hernández-Guerrero, Angélica; Castro-Reyes, Luz María; Yañez-Cruz, M.; Giau-Triulzi, Louis Francois De; Vinageras-Barroso, Javier; Téllez-Ávila, Félix Ignacio

doi:10.1007/s00464-019-06719-9

Cited by 11 publications

(12 citation statements)

References 10 publications

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“…Moreover, infection and physicochemical stimulation aggravate chronic inflammation after endoscopic treatment and delay extracellular matrix (ECM) degradation and the wound healing process. Faced with the great challenge of rapid hemorrhage after endoscopic treatment, a variety of commercial hemostatic spray powders that have the ability to spray toward the lesion through a catheter have been developed in recent years and have shown a certain therapeutic potential to promote gastric wound healing and hemostasis [9][10][11]. However, the hemostatic effects of these powders usually last for only a short time (up to one day) because they have low adhesive strength to the wound and dissolve quickly.…”

Section: Introductionmentioning

confidence: 99%

Injectable Self-Healing Adhesive pH-Responsive Hydrogels Accelerate Gastric Hemostasis and Wound Healing

et al. 2021

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Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are well-established therapeutics for gastrointestinal neoplasias, but complications after EMR/ESD, including bleeding and perforation, result in additional treatment morbidity and even threaten the lives of patients. Thus, designing biomaterials to treat gastric bleeding and wound healing after endoscopic treatment is highly desired and remains a challenge. Herein, a series of injectable pH-responsive self-healing adhesive hydrogels based on acryloyl-6-aminocaproic acid (AA) and AA-g-N-hydroxysuccinimide (AA-NHS) were developed, and their great potential as endoscopic sprayable bioadhesive materials to efficiently stop hemorrhage and promote the wound healing process was further demonstrated in a swine gastric hemorrhage/wound model. The hydrogels showed a suitable gelation time, an autonomous and efficient self-healing capacity, hemostatic properties, and good biocompatibility. With the introduction of AA-NHS as a micro-cross-linker, the hydrogels exhibited enhanced adhesive strength. A swine gastric hemorrhage in vivo model demonstrated that the hydrogels showed good hemostatic performance by stopping acute arterial bleeding and preventing delayed bleeding. A gastric wound model indicated that the hydrogels showed excellent treatment effects with significantly enhanced wound healing with type I collagen deposition, α-SMA expression, and blood vessel formation. These injectable self-healing adhesive hydrogels exhibited great potential to treat gastric wounds after endoscopic treatment.

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Section: Introductionmentioning

confidence: 99%

Injectable Self-Healing Adhesive pH-Responsive Hydrogels Accelerate Gastric Hemostasis and Wound Healing

et al. 2021

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“…TC-325 is the most studied and widely used hemostatic powder on the market, with studies on its clinical use in many settings of gastrointestinal bleeding ( Table 2 ). TC-325 has been successfully applied to many etiologies including peptic ulcer disease, malignant gastrointestinal bleeding, post-procedure gastrointestinal bleeding (endoscopic mucosal resection, sphincterotomy, ampullary resection, and polypectomy), variceal bleeding, portal hypertensive gastropathy/colopathy, and diverticular bleeding 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 . Of particular note is successful use in clinical scenarios not amenable to traditional endoscopic methods, such as malignant gastrointestinal bleeding with friable surfaces or diverticular bleeding.…”

Section: Resultsmentioning

confidence: 99%

Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field

et al. 2022

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Background and study aims Hemostatic powders are increasingly used to address limitations in conventional endoscopic techniques for gastrointestinal bleeding. Various agents exist with different compositions, characteristics, efficacy, and adverse events (AEs). We sought to review existing hemostatic powders, from preclinical to established agents. Methods A literature review on hemostatic powders for gastrointestinal bleeding was undertaken through a MEDLINE search from 2000–2021 and hand searching of articles. Relevant literature was critically appraised and reviewed for mechanism of action, hemostasis and rebleeding rate, factors associated with hemostatic failure, and AEs. Results The most established agents are TC-325 (Hemospray), EndoClot, and Ankaferd Blood Stopper (ABS). These agents have been successfully applied to a variety of upper and lower gastrointestinal bleeding etiologies, in the form of primary, combination, salvage, and bridging therapy. Few AEs have been reported, including visceral perforation, venous embolism, and self-limited abdominal pain. Newer agents include CEGP-003 and UI-EWD, which have shown results similar to those for the older agents in initial clinical studies. All aforementioned powders have high immediate hemostasis rates, particularly in scenarios not amenable to conventional endoscopic methods, but are limited by significant rates of rebleeding. Other treatments include TDM-621 (PuraStat) consisting of a liquid hemostatic agent newly applied to endoscopy and self-propelling thrombin powder (CounterFlow Powder), a preclinical but promising agent. Conclusions Rapid development of hemostatic powders and growing clinical expertise has established these agents as a valuable strategy in gastrointestinal bleeding. Further research will continue to refine the efficacy and applicability of these agents.

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“…Overall, 59 studies were included (n = 3417 patients). Hemospray (TC-325) was the sole intervention in 44 studies 15 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 , EndoClot in five 65 66 67 68 69 , PuraStat in four 70 71 72 73 , Nexpowder in three 74 75 76 and CEGP-003 77 in one. In addition, two studies included both Hemospray and EndoClot 78 79 .…”

Section: Resultsmentioning

confidence: 99%

“…Most of the bleeding lesions were classified as oozing bleeding (Forrest Ib). There were 11 studies 26 27 28 37 38 49 50 57 60 64 78 (n = 124 patients) that addressed patients with variceal bleeding. Full study and patient characteristics are shown in Table 2 .…”

Section: Resultsmentioning

confidence: 99%

Topical hemostatic agents in the management of upper gastrointestinal bleeding: a meta-analysis

et al. 2022

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Background 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. Primary 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. Amongst 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 risks (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 amongst RCTs and in malignant bleeding. Due to methodological limitations of available data, additional studies are needed to more confidently ascertain their effectiveness in patients with UGIB.

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

Cited by 11 publications

References 10 publications

Injectable Self-Healing Adhesive pH-Responsive Hydrogels Accelerate Gastric Hemostasis and Wound Healing

Injectable Self-Healing Adhesive pH-Responsive Hydrogels Accelerate Gastric Hemostasis and Wound Healing

Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field

Topical hemostatic agents in the management of upper gastrointestinal bleeding: a meta-analysis

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