麻豆传媒

A hemostatic powder, TC-325 (Hemospray), worked as well as standard treatment for endoscopic control of acute bleeds from nonvariceal upper gastrointestinal lesions, a randomized trial found.

In the study of over 200 patients, 90.1% of those who received TC-325 had their bleeding controlled within 30 days, as compared to 81.4% of those who received standard treatment, meeting criteria for non-inferiority, reported James Y.W. Lau, MD, of the Prince of Wales Hospital in Hong Kong, and colleagues.

Fewer treatment failures during an initial attempt at endoscopic control were seen in the TC-325 group (2.7%) compared to the standard treatment arm (9.7%) as well (OR 0.26, CI 0.07-0.95), the group wrote in .

No difference in recurrent bleeding within 30 days was observed between study arms (8.1% vs 8.8%, respectively), nor were there significant differences in treatment for further bleeding between the TC-325 and standard treatment groups, respectively, via:

• Surgery: 0.9% vs 0%
• Angiography: 2% vs 4%
• Further endoscopic treatments: 7% vs 9%

"TC-325 may be used as one of the first endoscopic treatments in patients with active bleeding from nonvariceal upper gastrointestinal lesions and can also be considered when other treatments have failed," wrote Lau and coauthors.

In 2018, the FDA allowed marketing of the product for treating most types of GI bleeding. TC-325 contains aluminum phyllosilicate clay and has been shown to stop cases of active bleeding by forming an adhesive barrier at the site, which can be used in a variety of settings.

In an , Alan Barkun, MD, MSc, of McGill University in Montreal, and Ali Alali, MB BCh, BAO, of Kuwait University, noted that "the significant difference in the immediate hemostasis rate favoring TC-325 may have resulted in part from procedural bias due to the unblinded endoscopists' decisions to cross over in the absence of a formal definition for failure of hemostasis at the index endoscopy."

Nine of 11 patients in the TC-325 arm crossed over versus just two of three in the standard therapy group.

Given its biological properties and limitations in the study, "for patients with bleeding ulcers, a cautious approach is prudent when choosing TC-325 alone," Barkun and Alali noted. "Performance of a second-look endoscopy 16 to 24 hours after successful immediate hemostasis in such instances may be a reasonable approach."

From September 2015 to December 2018, the study randomized 224 patients with nonvariceal acute bleeding to either TC-325 (n=111) or standard hemostatic treatment (n=113). Adults from three university hospitals in Hong Kong, Thailand, and Singapore were included if they were scheduled for an endoscopy. The primary outcome assessed bleeding control within 30 days of intervention. Bleeding cessation for a minimum of 5 minutes defined treatment success.

Researchers used a 3.7 mm dual channelled endoscope with one to two "bursts" of TC-325 sprayed by a carbon dioxide canister onto the bleeding site. Hemoclipping or contact thermocoagulation were used for standard treatment patients, regardless of pre-injected epinephrine use. Mean procedure times were similar between arms (17.6 vs 18.7 minutes).

Most of the patients in the study were men (65-69%) and the mean age was 66 to 69. Coexisting diseases included cancer (20-27%), ischemic heart disease (11-12%), and liver disease (9-12%).

Overall, 61% had bleeding attributed to gastroduodenal ulcers, 25% to other causes, and 15% due to tumors. There were 14 deaths in each group.

"Active bleeding is required for TC-325 to adhere to the bleeding lesion," the editorialists added. "Thus, the findings are generalizable only to patients with active spurting (Forrest Ia) or oozing (Forrest Ib) hemorrhage."

In addition to already noted limitations, Lau and colleagues pointed out that tumor bleeds were overrepresented among the TC-325 patients.

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