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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China-Japan Friendship Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; The Second Affiliated Hospital of Harbin Medical University
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• During diagnostic bronchoscopy, patients with bronchial bleeding that was not successfully controlled with cold (4°C) saline (3 times within 60 seconds, 5ml each time).

Exclusion Criteria:

• 1: Patients with contraindications for diagnostic flexible bronchoscopy.

2: Coagulopathy (PV INR >1.3).

3: Thrombocytopenia (<50x10^9) or anemia (hgb <80 g/L).

4: Direct oral anticoagulant, low molecular weight heparin, or antiplatelet therapy.

5: Thrombophilia, history of pulmonary embolism or deep vein thrombosis.

6: Contraindications for the use of epinephrine in the bronchus.

7: Coronary artery disease, cerebrovascular disease, history of rapid arrhythmias.

8: Uncontrolled pulmonary hypertension.

9: Cardiovascular decompensation.

10: Severe hypoxia (PaO2 <60mmHg, SaO2 <90%, FiO2 >=60%).