Hemostatic Powder Spray TC-325
| Hemostatic Powder Spray TC-325 | |
|---|---|
| Other names | Hemospray, TC-325 |
| Specialty | {{#Statements:p1995}} |
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]
History
[edit | edit source]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
[edit | edit source]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
[edit | edit source]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
[edit | edit source]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
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