Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase
- Conditions
- Iatrogenic Endobronchial Bleeding
- Interventions
- Registration Number
- NCT06149091
- Lead Sponsor
- China-Japan Friendship Hospital
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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).
-
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%).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic Acid Group Tranexamic Acid； Patients with iatrogenic airway bleeding who were randomly assigned to the group and failed to achieve hemostasis after three applications of cold saline within a given week were treated with tranexamic acid for hemostasis. Hemagglutinase Group Hemagglutinase Patients with iatrogenic airway bleeding who were randomly assigned to the group and failed to achieve hemostasis after three applications of cold saline within a given week were treated with Hemagglutinase for hemostasis. Adrenalin Group Adrenalin Patients with iatrogenic airway bleeding who were randomly assigned to the group and failed to achieve hemostasis after three applications of cold saline within a given week were treated with Adrenalin for hemostasis.
- Primary Outcome Measures
Name Time Method Intratracheal bleeding control rate Up to a single examination, no more than 1 minute after each drug application. Under bronchoscopy, physicians visually assess clot formation to evaluate bleeding control The percentage of iatrogenic bronchial bleeding successfully controlled in each group (%)
- Secondary Outcome Measures
Name Time Method Number of tranexamic acid/adrenaline/thrombin applications required to control bronchial bleeding Until the end of a single procedure (bronchoscopy), up to 1 minute after each drug application. Number of tranexamic acid/adrenaline/thrombin applications required to control bronchial bleeding
Number of recurrent bleeding episodes after infusion of tranexamic acid/adrenaline/thrombin (N) Within 24 hours after a single procedure (bronchoscopy) Number of recurrent bleeding episodes after infusion of tranexamic acid/adrenaline/thrombin (N)
Percentage (%) of iatrogenic bronchial bleeding successfully controlled in each group in relation to the severity of the bleeding. Up to the end of a single procedure (bronchoscopy), a maximum of 1 minute after each drug application. Percentage (%) of iatrogenic bronchial bleeding successfully controlled in each group in relation to the severity of the bleeding. Bronchoscopic physicians assess using a Visual Analog Scale (VAS) 1-10 (1 very mild - 10 very severe)
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳BeiJing, Beijing, China