Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tranexamic Acid Group 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. |
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.
|
| Active Comparator: Adrenalin Group 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. |
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.
|
| Experimental: Hemagglutinase Group 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
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%).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | BeiJing | Beijing | China | 100029 |
Sponsors and Collaborators
- China-Japan Friendship Hospital
- The Second Affiliated Hospital of Harbin Medical University
- The First Affiliated Hospital of Nanchang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZRJY2021-BJ08-02-01