Hemostatic Powder Spray TC-325

Hemostatic Powder Spray TC-325 (Hemospray or TC-325) is an inert, highly absorptive mineral agent which is used for the treatment of gastrointestinal bleeding. Applied during endoscopy to bleeding lesions, TC-325 is derived from bentonite, and is used to achieve hemostasis (control of bleeding) by absorbing water and creating a barrier that leads to mechanical tamponade (pressure) and concentration of clotting factors, resulting in enhanced coagulation (clotting of blood).[1] TC-325 was approved for gastrointestinal bleeding from causes other than gastric or esophageal varices (e.g., nonvariceal bleeding). TC-325 results in immediate control of bleeding in 91-93% of cases.[2][3] Technical success has gradually increased between 2011 and 2019, which may be due to device improvements or physician familiarity with the application of TC-325.[2]

Hemostatic Powder Spray TC-325
Other namesHemospray, TC-325

History

Hemostatic Powder Spray TC-325 was approved by the United States Food and Drug Administration in 2018 for gastrointestinal bleeding.[4] Technical success has gradually increased between 2011 and 2019, which may be due to device improvements or physician familiarity with the application of TC-325.[2]

Uses

TC-325 is recommended for temporary control of gastrointestinal bleeding when other treatments are ineffective or not available.[5] TC-325 may also be used for massive bleeding with poor visualization or diffuse bleeding due to cancer.[6]

The device is not FDA approved for the treatment of gastroesophageal variceal bleeding.[7] However, TC-325 is 90.4% effective in achieving initial hemostasis in variceal bleeding, and its use was associated with a 4.2% rate of rebleeding.[8] TC-325 use for variceal bleeding is safe.[9]

Efficacy

TC-325 is 91-93% effective in achieving initial control of bleeding,[3][2] but does not prevent re-bleeding from occurring.[3] Rebleeding is most likely to occur if the initial bleed was brisk (spurting) or hypotension was present.[10]

Risks

Risks of TC-325 use include failure to control bleeding, gastrointestinal perforation, bowel obstruction, or malfunction of device or delivery system. If TC-325 is used for the control of bleeding at the site of a sphincterotomy or ampullary resection, there is a risk of biliary obstruction. Additional risks include allergy to the TC-325 powder. The overall rate of adverse events to TC-325 is 0.7%.[11]

References
  1. Mourad, Fadi H; Leong, Rupert W (August 2018). "Role of hemostatic powders in the management of lower gastrointestinal bleeding: A review: Hemostatic agents lower intestinal bleed". Journal of Gastroenterology and Hepatology. 33 (8): 1445–1453. doi:10.1111/jgh.14114. PMID 29405446.
  2. Aziz, Muhammad (2020). "Efficacy of Hemospray in non-variceal upper gastrointestinal bleeding: a systematic review with meta-analysis". Annals of Gastroenterology. 33 (2): 145–154. doi:10.20524/aog.2020.0448. PMC 7049242. PMID 32127735.
  3. Ofosu, A; Ramai, D; John, F; Mohan, BP; Dhindsa, B; Antoine, G; Hajiyeva, G; Alatevi, EM; Ofori, E; Dhaliwal, AS; Gaduputi, V; Gurram, KC; Reddy, M; McDonough, S; Adler, DG (2021-05-01). "The Efficacy and Safety of Hemospray for the Management of Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis". Journal of Clinical Gastroenterology. 55 (5): e37–e45. doi:10.1097/MCG.0000000000001379. PMID 33470608. S2CID 225556360.
  4. "FDA approves Hemospray device to treat GI bleeding". Healio Gastroenterology. May 8, 2018.
  5. Barkun, Alan N.; Almadi, Majid; Kuipers, Ernst J.; Laine, Loren; Sung, Joseph; Tse, Frances; Leontiadis, Grigorios I.; Abraham, Neena S.; Calvet, Xavier; Chan, Francis K.L.; Douketis, James; Enns, Robert; Gralnek, Ian M.; Jairath, Vipul; Jensen, Dennis; Lau, James; Lip, Gregory Y.H.; Loffroy, Romaric; Maluf-Filho, Fauze; Meltzer, Andrew C.; Reddy, Nageshwar; Saltzman, John R.; Marshall, John K.; Bardou, Marc (3 December 2019). "Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group". Annals of Internal Medicine. 171 (11): 805–822. doi:10.7326/M19-1795. PMC 7233308. PMID 31634917.
  6. Mullady, Daniel K.; Wang, Andrew Y.; Waschke, Kevin A. (June 2020). "AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review". Gastroenterology. 159 (3): 1120–1128. doi:10.1053/j.gastro.2020.05.095. PMID 32574620. S2CID 220046314.
  7. "DE NOVO CLASSIFICATION REQUEST FOR HEMOSPRAY ENDOSCOPIC HEMOSTAT" (PDF). AccessData. FDA.
  8. de Rezende, Daniel Tavares; Brunaldi, Vitor Ottoboni; Bernardo, Wanderley Marques; Ribeiro, Igor Braga; Mota, Raquel Cristina Lins; Baracat, Felipe Iankelevich; de Moura, Diogo Turiani Hourneaux; Baracat, Renato; Matuguma, Sergio Eiji; de Moura, Eduardo Guimarães Hourneaux (December 2019). "Use of hemostatic powder in treatment of upper gastrointestinal bleeding: a systematic review and meta-analysis". Endoscopy International Open. 07 (12): E1704–E1713. doi:10.1055/a-0977-2897. PMC 6887646. PMID 31803822.
  9. Facciorusso, Antonio; Straus Takahashi, Marcelo; Eyileten Postula, Ceren; Buccino, Vincenzo Rosario; Muscatiello, Nicola (December 2019). "Efficacy of hemostatic powders in upper gastrointestinal bleeding: A systematic review and meta-analysis". Digestive and Liver Disease. 51 (12): 1633–1640. doi:10.1016/j.dld.2019.07.001. PMID 31401022.
  10. Rodríguez de Santiago, E; Burgos-Santamaría, D; Pérez-Carazo, L; Brullet, E; Ciriano, L; Riu Pons, F; de Jorge Turrión, MÁ; Prados, S; Pérez-Corte, D; Becerro-Gonzalez, I; Martinez-Moneo, E; Barturen, A; Fernández-Urién, I; López-Serrano, A; Ferre-Aracil, C; Lopez-Ibañez, M; Carbonell, C; Nogales, O; Martínez-Bauer, E; Terán Lantarón, Á; Pagano, G; Vázquez-Sequeiros, E; Albillos, A; TC-325 Collaboration Project, Endoscopy Group of the Spanish Association of, Gastroenterology. (October 2019). "Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis". Gastrointestinal Endoscopy. 90 (4): 581–590.e6. doi:10.1016/j.gie.2019.06.008. PMID 31220444.
  11. Chahal, D; Sidhu, H; Zhao, B; Jogendran, M; Dahiya, M; Tandon, P; Donnellan, F (2021-07-01). "Efficacy of Hemospray (TC-325) in the Treatment of Gastrointestinal Bleeding: An Updated Systematic Review and Meta-analysis". Journal of Clinical Gastroenterology. 55 (6): 492–498. doi:10.1097/MCG.0000000000001564. PMID 34049382. S2CID 235243320.
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