TC-325 on par with standard treatment for control of bleeding from upper nonvariceal lesions

The hemostatic powder TC-325 has demonstrated its noninferiority to standard treatment in the endoscopic control of bleeding from nonvariceal upper gastrointestinal causes, reports a study.

A one-sided, noninferiority, randomized controlled trial was conducted at university teaching hospitals across the Asia-Pacific region. A total of 224 adult patients with acute bleeding from a nonvariceal cause on upper gastrointestinal endoscopy were randomly assigned to receive either TC-325 (n=111) or standard hemostatic treatment (n=113).

Bleeding control within 30 days was the primary outcome; other outcomes analysed were failure to control bleeding during index endoscopy, recurrent bleeding after initial hemostasis, further interventions, blood transfusion, hospitalization, and death.

Of the patients, 136 (60.7 percent) had gastroduodenal ulcers, 33 (14.7 percent) had tumours, and 55 (24.6 percent) had other causes of bleeding.

One hundred of 111 (90.1 percent) patients in the TC-325 group and 92 of 113 (81.4 percent) in the standard treatment group were able to control bleeding within 30 days (risk difference, 8.7 percentage points, one-sided 95 percent CI, 0.95). Moreover, the TC-325 group had fewer failures of hemostasis during index endoscopy (3 vs 11; odds ratio, 0.26, 95 percent CI, 0.07–0.95).

Recurrent bleeding within 30 days did not differ between groups (9 vs 10). No between-group difference was also noted in the need for further interventions (further endoscopic treatment: 8 vs 10; angiography: 2 vs 4; surgery: 1 vs 0). Notably, 14 deaths occurred in each group (12.6 percent vs 12.4 percent).

The study was limited by the clinicians who were not blinded to treatment.