Controlling bleeding during bronchoscopy with medications
Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid，Adrenalin and Hemagglutinase: a Double-blind Randomized Controlled Trial
This study is testing a new medication called hemagglutinase to see if it can better control bleeding during bronchoscopy compared to other treatments like epinephrine and tranexamic acid for patients who have bleeding that saline can't stop.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (BeiJing, Beijing) |
| Trial ID | NCT06149091 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hemagglutinase in controlling iatrogenic endobronchial bleeding during diagnostic bronchoscopy. It is a prospective, multi-center, double-blind, cluster randomized controlled trial comparing hemagglutinase with topical epinephrine and tranexamic acid. The trial will be conducted in major hospitals in China, focusing on patients who experience bronchial bleeding that is not controlled by saline. The goal is to determine the best intervention for managing this complication.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing diagnostic bronchoscopy who experience bronchial bleeding not controlled by saline.
Not a fit: Patients with contraindications for bronchoscopy or those with coagulopathy or severe cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing bleeding during bronchoscopy, improving patient safety and outcomes.
How similar studies have performed: While there have been studies on managing bleeding during bronchoscopy, the specific combination of interventions in this trial is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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%).
Where this trial is running
BeiJing, Beijing
- China-Japan Friendship Hospital — BeiJing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.