NCT06149091

Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase

Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid，Adrenalin and Hemagglutinase: a Double-blind Randomized Controlled Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A prospective national multi-center study will be conducted to evaluate the effectiveness of hemocoagulase in iatrogenic airway bleeding in a large class III hospital, such as the Second Affiliated Hospital of Harbin Medical University, the First Affiliated Hospital of Nanchang University, and to compare it with topical epinephrine and tranexamic acid in a prospective double-blind cluster randomized controlled trial.

Conditions

• Iatrogenic Endobronchial Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid；	Tranexamic acid (TXA) is an antifibrinolytic drug that competitively inhibits the activation of plasminogen. After its efficacy and safety were confirmed in several randomized controlled trials, both systemic and topical administration of TXA have been widely used for hemostasis in trauma and various surgical settings.
DRUG	Adrenalin	In diagnostic bronchoscopy, one of the most commonly used topical hemostatic agent is epinephrine. The primary mechanism of epinephrine is vasoconstriction, leading to reduced blood flow and hemostasis.
DRUG	Hemagglutinase	Thrombin injection (Batroxobin) is an enzymatic hemostatic agent refined from the venom of the Brazilian lancehead snake. It promotes clot formation at the bleeding site, characterized by rapid and effective hemostasis and high safety. It is now widely used for clinical prevention and treatment of perioperative bleeding and oozing. Multiple randomized controlled studies have evaluated the safety and efficacy of intravenous/topical application of thrombin in various trauma and surgical settings.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-11-28
• Last updated: 2023-11-28

Locations

1 site across 1 country: China