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

Early Phase 1UnknownNCT06149091

China-Japan Friendship Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Iatrogenic Endobronchial Bleeding

Interventions

Tranexamic Acid；DRUG

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.

AdrenalinDRUG

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.

HemagglutinaseDRUG

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

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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%).

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Intratracheal bleeding control rate

The percentage of iatrogenic bronchial bleeding successfully controlled in each group (%)

Time frame: 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

Secondary Outcomes

Number of tranexamic acid/adrenaline/thrombin applications required to control bronchial bleeding

Time frame: Until the end of a single procedure (bronchoscopy), up to 1 minute after each drug application.

Number of recurrent bleeding episodes after infusion of tranexamic acid/adrenaline/thrombin (N)

Time frame: Within 24 hours after a single procedure (bronchoscopy)

Percentage (%) of iatrogenic bronchial bleeding successfully controlled in each group in relation to the severity of the bleeding.

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)

Time frame: Up to the end of a single procedure (bronchoscopy), a maximum of 1 minute after each drug application.

Data from ClinicalTrials.gov

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