Status:

UNKNOWN

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

Lead Sponsor:

China-Japan Friendship Hospital

Collaborating Sponsors:

The Second Affiliated Hospital of Harbin Medical University

The First Affiliated Hospital of Nanchang University

Conditions:

Iatrogenic Endobronchial Bleeding

Eligibility:

All Genders

18-90 years

Phase:

EARLY_PHASE1

Brief 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 Ho...

Eligibility Criteria

Inclusion

  • 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

  • 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%).

Key Trial Info

Start Date :

December 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT06149091

Start Date

December 1 2023

End Date

December 31 2024

Last Update

November 28 2023

Active Locations (1)

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1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029