Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase
NCT ID: NCT06149091
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
300 participants
INTERVENTIONAL
2023-12-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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%).
18 Years
90 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Harbin Medical University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Principal Investigator
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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ZRJY2021-BJ08-02-01
Identifier Type: -
Identifier Source: org_study_id