Haemostatic powder noninferior to standard treatment for upper GI bleeding

TC-325, a bentonite haemostatic powder with aluminium phyllosilicate clay as the main ingredient, is found to be comparable to standard treatment in controlling active upper gastrointestinal bleeding, according to results of a randomized clinical trial by the Chinese University of Hong Kong (CUHK), King Chulalongkorn Memorial University Hospital in Thailand, and Changi General Hospital in Singapore.

In the one-sided, noninferiority, randomized controlled trial, 224 adult patients who had signs of acute upper gastrointestinal bleeding from nonvariceal causes and were undergoing endoscopy were randomized in a 1:1 ratio to receive either TC-325 (n=111; mean age, 68.5 years) or standard treatment (n=113, mean age, 66.3 years). The causes of bleeding in the enrolled patients included gastroduodenal ulcers (60.7 percent), tumours (14.7 percent), and other causes (24.6 percent). [Ann Intern Med 2021;doi:10.7326/M21-0975]

Bleeding was controlled within 30 days in 90.1 percent of patients in the TC-325 group compared with 81.4 percent of patients in the standard treatment group (odds ratio [OR], 8.7; 1-sided 95 percent confidence interval [CI], 0.95). “The lower limit of the CI for the treatment difference did not extend beyond the prespecified noninferiority margin of 10, indicating that TC-325 is noninferior to standard treatment [ie, use of clips, contact thermocoagulation for peptic ulcers, and argon plasma coagulation for diffuse vascular lesions and tumour] in the control of bleeding,” pointed out the researchers.

A lower rate of failure of haemostasis during index endoscopy was noted in the TC-325 group compared with the standard treatment group (2.7 percent vs 9.7 percent; OR, 0.26; 95 percent CI, 0.07 to 0.95).

After initial haemostasis, the rate of recurrent bleeding within 30 days did not differ significantly between groups (8.1 percent vs 8.8 percent; OR, 0.91; 95 percent CI, 0.37 to 2.22). Similarly, the need for further interventions also did not differ significantly between groups (9.0 percent vs 10.6 percent; OR 0.83, 95 percent CI, 0.34 to 2.02). Interventions for further bleeding control included endoscopic treatment (7.2 percent vs 8.8 percent), angiography (1.8 percent and 3.5 percent), and surgery (0.9 percent vs 0 percent).

TC-325, when in contact with blood, forms an adherent barrier at the bleeding site. “TC-325 has the advantage of being technically easy to apply and is particularly good for treating a diffuse oozing haemorrhage from a large area, such as in bleeding gastrointestinal cancers,” said the researchers.

For the last 10 years, endoscopic application of TC-325 has been used as a rescue therapy in patients in whom standard treatment failed to control bleeding. 

“This is the world’s first randomized clinical trial with a sufficient sample size to compare TC-325 monotherapy with standard treatment,” the researchers noted.

With the results showing that a single endoscopic application of TC-325 led to bleeding control in 90 percent of patients and was noninferior to standard treatment, the researchers suggested that TC-325 can be considered as a first-line endoscopic treatment for upper gastrointestinal bleeding from nonvariceal causes in addition its use as a rescue therapy.