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

NCT06149091 | Unknown Early Phase 1 DMC

• 1 other identifier: ZRJY2021-BJ08-02-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Iatrogenic Endobronchial Bleeding

Keywords

flexible bronchoscopy; diagnostic flexible bronchoscopy; hemocoagulase; Tranexamic Acid; Adrenalin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

  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.

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

Study Arms (3)

Tranexamic Acid Group

ACTIVE COMPARATOR

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；

Adrenalin Group

ACTIVE COMPARATOR

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

Hemagglutinase Group

EXPERIMENTAL

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

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.

Tranexamic Acid Group

Adrenalin DRUG

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.

Adrenalin Group

Hemagglutinase DRUG

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.

Hemagglutinase Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• : Patients with contraindications for diagnostic flexible bronchoscopy.
• : Coagulopathy (PV INR \>1.3).
• : Thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/L).
• : Direct oral anticoagulant, low molecular weight heparin, or antiplatelet therapy.
• : Thrombophilia, history of pulmonary embolism or deep vein thrombosis.
• : Contraindications for the use of epinephrine in the bronchus.
• : Coronary artery disease, cerebrovascular disease, history of rapid arrhythmias.
• : Uncontrolled pulmonary hypertension.
• : Cardiovascular decompensation.
• : Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90%, FiO2 \>=60%).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid; Epinephrine

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)