Clinical trial NCT06149091: Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase
Official title: Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid，Adrenalin and Hemagglutinase: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Iatrogenic Endobronchial Bleeding
Keywords: flexible bronchoscopy
diagnostic flexible bronchoscopy
hemocoagulase
Tranexamic Acid
Adrenalin
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
name: The First Affiliated Hospital of Nanchang University
First posted: 2023-11-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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%).

Primary outcomes:
measure: Intratracheal bleeding control rate
timeFrame: 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:
measure: Number of tranexamic acid/adrenaline/thrombin applications required to control bronchial bleeding
timeFrame: Until the end of a single procedure (bronchoscopy), up to 1 minute after each drug application.
measure: Number of recurrent bleeding episodes after infusion of tranexamic acid/adrenaline/thrombin (N)
timeFrame: Within 24 hours after a single procedure (bronchoscopy)
measure: Percentage (%) of iatrogenic bronchial bleeding successfully controlled in each group in relation to the severity of the bleeding.
timeFrame: Up to the end of a single procedure (bronchoscopy), a maximum of 1 minute after each drug application.
Other outcomes:
Locations:
city: BeiJing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: