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

Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid，Adrenalin and Hemagglutinase: a Double-blind Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Iatrogenic Endobronchial Bleeding
• Intervention / Treatment: Drug: Tranexamic Acid；; Drug: Adrenalin; Drug: Hemagglutinase

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Gang Hou, Professor; Phone Number: 13840065481; Email: hougangcmu@163.com
      • Contact: Mingming Deng, Doctor; Phone Number: 18801336854; Email: isdeng1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intratracheal bleeding control rate	The percentage of iatrogenic bronchial bleeding successfully controlled in each group (%)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of tranexamic acid/adrenaline/thrombin applications required to control bronchial bleeding	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 recurrent bleeding episodes after infusion of tranexamic acid/adrenaline/thrombin (N)	Number of recurrent bleeding episodes after infusion of tranexamic acid/adrenaline/thrombin (N)	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)	Up to the end of a single procedure (bronchoscopy), a maximum of 1 minute after each drug application.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Tranexamic Acid; flexible bronchoscopy; diagnostic flexible bronchoscopy; hemocoagulase; Adrenalin
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: ZRJY2021-BJ08-02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No