Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial.

ABSTRACT:

Objective

A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze.

Methods

This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale t

SUBMITTER: Mumtaz M 

PROVIDER: S-EPMC10328980 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature