Iatrogenic Endobronchial BleedingEarly Phase 1NCT06149091
Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase
A Early Phase 1 study testing Tranexamic Acid；, Adrenalin and Hemagglutinase in people with Iatrogenic Endobronchial Bleeding, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Iatrogenic Endobronchial Bleeding
- What is being tested?
- Tranexamic Acid；, Adrenalin and Hemagglutinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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%).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Gang Hou, Professor, 13840065481, hougangcmu@163.com
Mingming Deng, Doctor, 18801336854, isdeng1017@163.com
About this study
Official title: 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.
- Conditions
- Iatrogenic Endobronchial Bleeding
- Being tested
- Tranexamic Acid；, Adrenalin, Hemagglutinase
- Keywords
- flexible bronchoscopy, diagnostic flexible bronchoscopy, hemocoagulase, Tranexamic Acid, Adrenalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Hemagglutinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratracheal bleeding control rate
The percentage of iatrogenic bronchial bleeding successfully controlled in each group (%)
Measured: 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
Number of tranexamic acid/adrenaline/thrombin applications required to control bronchial bleeding
Measured: 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)
Measured: 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)
Measured: Up to the end of a single procedure (bronchoscopy), a maximum of 1 minute after each drug application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic Endobronchial BleedingStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149091
- Sponsor's protocol ID
- ZRJY2021-BJ08-02-01
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid，Adrenalin and Hemagglutinase: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06149091
- Acronym / sponsor ID
- ZRJY2021-BJ08-02-01
- Conditions
- Iatrogenic Endobronchial Bleeding
- Keywords
- flexible bronchoscopy, diagnostic flexible bronchoscopy, hemocoagulase, Tranexamic Acid, Adrenalin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Nanchang University
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Group | Active comparator | Drug: Tranexamic Acid；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. |
| Adrenalin Group | Active comparator | Drug: AdrenalinPatients 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. |
| Hemagglutinase Group | Experimental | Drug: HemagglutinasePatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Tranexamic Acid Group |
| AdrenalinIn 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. | Drug | Adrenalin Group |
| HemagglutinaseThrombin 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. | Drug | Hemagglutinase Group |
Primary outcome
Intratracheal bleeding control rate
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
The percentage of iatrogenic bronchial bleeding successfully controlled in each group (%)
3 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.
Time frame: Up to the end of a single procedure (bronchoscopy), a maximum of 1 minute after each drug application.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic Acid；, Adrenalin and Hemagglutinase in people with Iatrogenic Endobronchial Bleeding, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratracheal bleeding control rate (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.