A Prospective, Multicenter, Randomized, Noninferiority Trial of Stopad^® Versus Tachosil^® for Hemostasis After Liver Resection.

ABSTRACT:

Background

Hemostatic products are widely used to control bleeding in hepatic resections. Stopad is a pad-type hemostatic agent containing carboxymethyl chitosan and recombinant thrombin-like hemocoagulase.

Methods

We conducted a prospective, multicenter, randomized, noninferiority study of Stopad vs. Tachosil in 104 patients who required open hepatic resection. The subjects were randomized 1:1 to either the investigational group (Stopad; 53) or the control group (Tachosil; 51).

Results

The 3-min bleeding control success rate was 92.45% in the Stopad group and 90.20% in the Tachosil group. The lower bound of the one-sided 97.5% confidence level for the between-group difference in the success rate was -9.82%, which was within the preset noninferiority limit of -22.9%.

SUBMITTER: Lim SY 

PROVIDER: S-EPMC11898775 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature