ORLANDO – TC-325 (Hemospray), a proprietary mineral powder blend developed for endoscopic hemostasis, promoted immediate hemostasis and prevented rebleeding in patients with malignant gastrointestinal bleeding in a randomized pilot trial.
Nine of 10 patients randomized to receive treatment with TC-325 experienced immediate hemostasis, compared with 4 of 10 patients randomized to receive standard of care (usually argon plasma coagulation, sometimes with radiation therapy), Alan Barkun, MD, of McGill University, Montreal reported at the World Congress of Gastroenterology at ACG 2017.
Five of six patients in the standard of care group who did not achieve immediate hemostasis crossed over to TC-325. Hemostasis was then achieved at index endoscopy in 80% of these crossovers, said Dr. Barkun, whose work received the 2017 GI Bleeding Category Award at the congress.
“So a total of 15 patients were treated with Hemospray among both groups, and 100% of them achieved immediate hemostasis,” he said. “We also assessed feasibility of recruitment and randomization, and it was indeed demonstrated in the context of this feasibility trial.”
Secondary measures, including the use of additional hemostatic approaches, blood transfusions, length of stay, and mortality, among others, did not differ between the two groups.
“This pilot trial is the first to assess TC-325 in patients with malignant bleeding, allowing us to plan for adequate powering and demonstrating feasibility for a larger multicenter, randomized, controlled trial,” he said. “Although this trial was not powered to seek statistically significant differences, the observed results suggest that TC-325 may indeed be a promising hemostatic modality in managing patients with malignant bleeding in achieving both immediate hemostasis and in our minds, surprisingly, perhaps delayed rebleeding.”
Hemospray, which is approved in Canada for upper/lower gastrointestinal bleeding of any etiology, as well as in Mexico and in some countries in Europe, Asia, and South America, works by forming a mechanical barrier over the bleeding site. The powder absorbs water, then acts both cohesively and adhesively to form that barrier, according to information from Cook Medical, which developed the product. It is not currently approved for this indication in the United States.
“An adequately powered randomized, controlled trial is now needed to better determine any beneficial downstream effect on subsequent rebleeding and health care resource use when compared to existing standard of care,” he concluded.
Dr. Barkun is an advisory committee/board member and consultant for Cook Medical and has received grant/research support from the company.