Hemostatic Powder Spray TC-325
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| name = Hemostatic Powder Spray TC-325
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| synonyms = Hemospray, TC-325
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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).{{cite journal |last1=Mourad |first1=Fadi H |last2=Leong |first2=Rupert W |title=Role of hemostatic powders in the management of lower gastrointestinal bleeding: A review: Hemostatic agents lower intestinal bleed |journal=Journal of Gastroenterology and Hepatology |date=August 2018 |volume=33 |issue=8 |pages=1445–1453 |doi=10.1111/jgh.14114|pmid=29405446 |doi-access=free }} 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. 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.
History
Hemostatic Powder Spray TC-325 was approved by the United States Food and Drug Administration in 2018 for gastrointestinal bleeding.{{cite news |title=FDA approves Hemospray device to treat GI bleeding |url=https://www.healio.com/news/gastroenterology/20180508/fda-approves-hemospray-device-to-treat-gi-bleeding#:~:text=The%20FDA%20announced%20it%20has,according%20to%20a%20press%20release. |work=Healio Gastroenterology |date=May 8, 2018}}
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.
Uses
TC-325 is recommended for temporary control of gastrointestinal bleeding when other treatments are ineffective or not available.{{cite journal |last1=Barkun |first1=Alan N. |last2=Almadi |first2=Majid |last3=Kuipers |first3=Ernst J. |last4=Laine |first4=Loren |last5=Sung |first5=Joseph |last6=Tse |first6=Frances |last7=Leontiadis |first7=Grigorios I. |last8=Abraham |first8=Neena S. |last9=Calvet |first9=Xavier |last10=Chan |first10=Francis K.L. |last11=Douketis |first11=James |last12=Enns |first12=Robert |last13=Gralnek |first13=Ian M. |last14=Jairath |first14=Vipul |last15=Jensen |first15=Dennis |last16=Lau |first16=James |last17=Lip |first17=Gregory Y.H. |last18=Loffroy |first18=Romaric |last19=Maluf-Filho |first19=Fauze |last20=Meltzer |first20=Andrew C. |last21=Reddy |first21=Nageshwar |last22=Saltzman |first22=John R. |last23=Marshall |first23=John K. |last24=Bardou |first24=Marc |title=Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group |journal=Annals of Internal Medicine |date=3 December 2019 |volume=171 |issue=11 |pages=805–822 |doi=10.7326/M19-1795|pmid=31634917 |pmc=7233308 }} TC-325 may also be used for massive bleeding with poor visualization or diffuse bleeding due to cancer.{{cite journal |last1=Mullady |first1=Daniel K. |last2=Wang |first2=Andrew Y. |last3=Waschke |first3=Kevin A. |title=AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review |journal=Gastroenterology |date=June 2020 |volume=159 |issue=3 |pages=1120–1128 |doi=10.1053/j.gastro.2020.05.095|pmid=32574620 |s2cid=220046314 }}
The device is not FDA approved for the treatment of gastroesophageal variceal bleeding.{{cite web |title=DE NOVO CLASSIFICATION REQUEST FOR HEMOSPRAY ENDOSCOPIC HEMOSTAT |url=https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170015.pdf |archive-url=https://web.archive.org/web/20210117013043/https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170015.pdf |url-status=dead |archive-date=January 17, 2021 |website=AccessData |publisher=FDA}} 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.{{cite journal |last1=de Rezende |first1=Daniel Tavares |last2=Brunaldi |first2=Vitor Ottoboni |last3=Bernardo |first3=Wanderley Marques |last4=Ribeiro |first4=Igor Braga |last5=Mota |first5=Raquel Cristina Lins |last6=Baracat |first6=Felipe Iankelevich |last7=de Moura |first7=Diogo Turiani Hourneaux |last8=Baracat |first8=Renato |last9=Matuguma |first9=Sergio Eiji |last10=de Moura |first10=Eduardo Guimarães Hourneaux |title=Use of hemostatic powder in treatment of upper gastrointestinal bleeding: a systematic review and meta-analysis |journal=Endoscopy International Open |date=December 2019 |volume=07 |issue=12 |pages=E1704–E1713 |doi=10.1055/a-0977-2897|pmid=31803822 |pmc=6887646 |doi-access=free }} TC-325 use for variceal bleeding is safe.{{cite journal |last1=Facciorusso |first1=Antonio |last2=Straus Takahashi |first2=Marcelo |last3=Eyileten Postula |first3=Ceren |last4=Buccino |first4=Vincenzo Rosario |last5=Muscatiello |first5=Nicola |title=Efficacy of hemostatic powders in upper gastrointestinal bleeding: A systematic review and meta-analysis |journal=Digestive and Liver Disease |date=December 2019 |volume=51 |issue=12 |pages=1633–1640 |doi=10.1016/j.dld.2019.07.001|pmid=31401022 |s2cid=199539602 }}
Efficacy
TC-325 is 91-93% effective in achieving initial control of bleeding,{{cite journal |last1=Aziz |first1=Muhammad |title=Efficacy of Hemospray in non-variceal upper gastrointestinal bleeding: a systematic review with meta-analysis |journal=Annals of Gastroenterology |date=2020 |volume=33 |issue=2 |pages=145–154 |doi=10.20524/aog.2020.0448|pmid=32127735 |pmc=7049242 |doi-access=free }} but does not prevent re-bleeding from occurring.{{cite journal |last1=Ofosu |first1=A |last2=Ramai |first2=D |last3=John |first3=F |last4=Mohan |first4=BP |last5=Dhindsa |first5=B |last6=Antoine |first6=G |last7=Hajiyeva |first7=G |last8=Alatevi |first8=EM |last9=Ofori |first9=E |last10=Dhaliwal |first10=AS |last11=Gaduputi |first11=V |last12=Gurram |first12=KC |last13=Reddy |first13=M |last14=McDonough |first14=S |last15=Adler |first15=DG |title=The Efficacy and Safety of Hemospray for the Management of Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis. |journal=Journal of Clinical Gastroenterology |date=2021-05-01 |volume=55 |issue=5 |pages=e37–e45 |doi=10.1097/MCG.0000000000001379 |pmid=33470608|s2cid=225556360 }} Rebleeding is most likely to occur if the initial bleed was brisk (spurting) or hypotension was present.{{cite journal |last1=Rodríguez de Santiago |first1=E |last2=Burgos-Santamaría |first2=D |last3=Pérez-Carazo |first3=L |last4=Brullet |first4=E |last5=Ciriano |first5=L |last6=Riu Pons |first6=F |last7=de Jorge Turrión |first7=MÁ |last8=Prados |first8=S |last9=Pérez-Corte |first9=D |last10=Becerro-Gonzalez |first10=I |last11=Martinez-Moneo |first11=E |last12=Barturen |first12=A |last13=Fernández-Urién |first13=I |last14=López-Serrano |first14=A |last15=Ferre-Aracil |first15=C |last16=Lopez-Ibañez |first16=M |last17=Carbonell |first17=C |last18=Nogales |first18=O |last19=Martínez-Bauer |first19=E |last20=Terán Lantarón |first20=Á |last21=Pagano |first21=G |last22=Vázquez-Sequeiros |first22=E |last23=Albillos |first23=A |last24=TC-325 Collaboration Project, Endoscopy Group of the Spanish Association of |first24=Gastroenterology. |title=Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis. |journal=Gastrointestinal Endoscopy |date=October 2019 |volume=90 |issue=4 |pages=581–590.e6 |doi=10.1016/j.gie.2019.06.008 |pmid=31220444|s2cid=195192053 }}
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%.{{cite journal |last1=Chahal |first1=D |last2=Sidhu |first2=H |last3=Zhao |first3=B |last4=Jogendran |first4=M |last5=Dahiya |first5=M |last6=Tandon |first6=P |last7=Donnellan |first7=F |title=Efficacy of Hemospray (TC-325) in the Treatment of Gastrointestinal Bleeding: An Updated Systematic Review and Meta-analysis. |journal=Journal of Clinical Gastroenterology |date=2021-07-01 |volume=55 |issue=6 |pages=492–498 |doi=10.1097/MCG.0000000000001564 |pmid=34049382|s2cid=235243320 }}
References
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