Prophylactic Hemostatic Treatment to Control Iatrogenic Bleeding During Endobronchial Biopsy (PROTECT Study): A Multicenter, Randomized, Single-Anonymized, Placebo-Controlled Study.

BACKGROUND

Iatrogenic bleeding related to endobronchial biopsy could be catastrophic and might lead to fatal outcomes. Although some guidelines and studies recommend the prophylactic use of hemostatic agents, there is still insufficient evidence from clinical studies.

RESEARCH QUESTION: Is prophylactic hemostatic treatment effective for controlling bleeding in patients undergoing endobronchial biopsy?

STUDY DESIGN AND

METHODS

In this multicenter, randomized, placebo-controlled trial, eligible participants scheduled to undergo endobronchial biopsy were randomly assigned (1:1:1) to the adrenaline group, the ice-cold saline group, or the saline (placebo) group. The primary efficacy outcomes were defined as the Bleeding Severity Scale and the visual analog scale in the termination of the biopsy.

RESULTS

A total of 462 participants were randomly assigned to the 3 groups and assessed for efficacy and safety outcomes. Overall, prophylactic hemostasis did not statistically improve the bleeding condition based on the Bleeding Severity Scale or the visual analog scale. However, in the subgroup of patients < 65 years of age, the incidence of bleeding in the ice-cold saline group showed a decreasing trend compared with the placebo group (relative risk, 0.90; 95% CI, 0.82-0.99; P = .04). Besides, our findings demonstrated the safety of prophylactic hemostasis.

INTERPRETATION: We did not observe any improvement in biopsy-related iatrogenic bleeding with the prophylactic hemostasis. However, we observed a trend toward reduced bleeding with prophylactic hemostasis in the subgroup of patients < 65 years of age, which merits further study.

CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Register; No.: ChiCTR2400089591; URL: https://www.chictr.org.cn/indexEN.html.