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 An endoscopy is a procedure used in medicine to look inside the body. The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes are insert ...

to bleeding lesions, TC-325 is derived from bentonite, and is used to achieve

hemostasis In biology, hemostasis or haemostasis is a process to prevent and stop bleeding, meaning to keep blood within a damaged blood vessel (the opposite of hemostasis is hemorrhage). It is the first stage of wound healing. This involves coagulation, whi ...

(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 Coagulation, also known as clotting, is the process by which blood changes from a liquid to a gel, forming a blood clot. It potentially results in hemostasis, the cessation of blood loss from a damaged vessel, followed by repair. The mechanism o ...

(clotting of blood). TC-325 was approved for gastrointestinal bleeding from causes other than gastric or

esophageal varices Esophageal varices are extremely dilated sub-mucosal veins in the lower third of the esophagus. They are most often a consequence of portal hypertension, commonly due to cirrhosis. People with esophageal varices have a strong tendency to develop ...

(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 The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

in 2018 for gastrointestinal bleeding. 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. TC-325 may also be used for massive bleeding with poor visualization or diffuse bleeding due to cancer. The device is not FDA approved for the treatment of gastroesophageal variceal bleeding. 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. TC-325 use for variceal bleeding is safe.

Efficacy

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

hypotension Hypotension is low blood pressure. Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps out blood. Blood pressure is indicated by two numbers, the systolic blood pressure (the top number) and the dias ...

was present.

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%.

References

{{Antihemorrhagics, state=open Antihemorrhagics Endoscopy Gastroenterology Implants (medicine)