Endobronchial BleedingCATERNCT07759089
The Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding
A study testing Adrenaline and Tranexamic Acid in people with Endobronchial Bleeding and Hemoptysis, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
Trial summary
During bronchoscopy (a procedure using a thin, flexible camera to look inside the airways), doctors sometimes take small tissue samples (biopsies) to diagnose lung conditions. This can cause bleeding in the airway. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endobronchial Bleeding, Hemoptysis
- What is being tested?
- Adrenaline and Tranexamic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jan 2022to 2 Jan 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients of any age and gender undergoing diagnostic flexible bronchoscopy for suspected benign or malignant airway disease
- Required endobronchial forceps biopsy during the procedure
- Developed moderate endobronchial bleeding following biopsy (defined as bleeding that obscured the bronchoscopic view, required repeated suctioning to clear the airway, and required endoscopic intervention for hemostasis, but remained hemodynamically stable)
Who cannot join
- Severe bleeding (requiring instillation of ice-cold saline, bronchoscopic tamponade, electrocautery, or argon plasma coagulation)
- Life-threatening bleeding (requiring endotracheal intubation, or spontaneous hemoptysis of more than 100-150 mL per hour)
- Contraindications to bronchoscopy, including:
- Cardiac arrhythmias
- Oxygen saturation below 90% on supplemental oxygen
- Acute respiratory failure with hypercapnia
Show all 10Show fewer
- Tracheal obstruction
- Bleeding diathesis with raised INR or platelet count less than 50,000/mm³
- Unstable coronary artery disease
- Hypersensitivity to tranexamic acid or adrenaline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between the Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding - A Randomized Controlled Trial
During bronchoscopy (a procedure using a thin, flexible camera to look inside the airways), doctors sometimes take small tissue samples (biopsies) to diagnose lung conditions. This can cause bleeding in the airway. Doctors currently use a medicine called adrenaline to stop this bleeding, but it doesn't always work, and bleeding can come back afterward. Another medicine, tranexamic acid, may work better because it helps blood clot and stay clotted, rather than just narrowing the blood vessels.
This study compared tranexamic acid and adrenaline, both given directly onto the bleeding site through the bronchoscope, in patients who developed moderate bleeding after a biopsy. The goal was to find out which medicine stopped the bleeding better right away, and which one was less likely to let the bleeding start again within 30 minutes.
Read the detailed description
This was a randomized controlled trial conducted at the Department of Pulmonology, Shaikh Zayed Hospital, Federal Postgraduate Medical Institute, Lahore, Pakistan, over a 12-month period. Adult patients undergoing diagnostic flexible bronchoscopy with endobronchial forceps biopsy who developed moderate post-biopsy bleeding (bleeding that obscured the bronchoscopic view and required repeated suctioning and endoscopic intervention, but without hemodynamic instability) were randomized by lottery method into two equal groups (n=38 each).
Group A received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; 0.05 mg/mL), and Group B received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; 25 mg/mL). The assigned drug was instilled directly onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, with administration repeated up to three times at 30-second intervals if bleeding persisted.
The primary outcome was immediate hemostasis, defined as cessation of oozing and/or formation of a stable clot within 90 seconds of drug instillation. The secondary outcome was rebleeding within 30 minutes of initial hemostasis, assessed by repeat bronchoscopic inspection. If bleeding persisted beyond 90 seconds despite maximal drug administration, this was classified as treatment failure, and rescue measures (cold saline, crossover drug instillation, wedge tamponade, electrocautery, or argon plasma coagulation) were used.
Demographic and clinical data (age, gender, BMI, smoking status, symptom duration, diabetes, hypertension) were recorded, and stratified subgroup analyses were performed. Statistical analysis used the Chi-square test for intergroup comparisons, with p≤0.05 considered significant.
- Conditions
- Endobronchial Bleeding, Hemoptysis
- Being tested
- Adrenaline, Tranexamic Acid
- Keywords
- ranexamic acid, adrenaline, Endobronchial bleeding, Bronchoscopy, endobronchial biopsy, Hemostasis
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
1 mg adrenaline diluted in 20 mL normal saline (0.05 mg/mL), administered topically via bronchoscope working channel in 5 mL aliquots, up to 3 applications at 30-second intervals.
Tranexamic AcidDrug
500 mg tranexamic acid diluted in 20 mL normal saline (25 mg/mL), administered topically via bronchoscope working channel in 5 mL aliquots, up to 3 applications at 30-second intervals.
| Study group | Role | What they receive |
|---|---|---|
| Adrenaline Group | Active comparator | Patients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; concentration 0.05 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted. Receives: Drug: Adrenaline |
| Tranexamic Acid Group | Experimental | Patients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; concentration 25 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Hemostasis (Bleeding Cessation)
Immediate bleeding control, defined as direct bronchoscopic observation of cessation of oozing and/or formation of a stable clot at the bleeding site, assessed within 90 seconds of drug instillation. If bleeding persisted beyond 90 seconds despite maximal drug administration (up to 3 applications), this was classified as treatment failure and rescue hemostatic measures were initiated.
Measured: Within 90 seconds of drug instillation
Secondary outcomes (1)
Rebleeding
Fresh bleeding from the same biopsy site following initial hemostasis, assessed by close clinical observation and repeat inspection with flexible bronchoscopy, with pulse oximetry monitoring to confirm clot stability and adequate ventilation.
Measured: Within 30 minutes of initial hemostasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start3 Jan 2022
- Primary completion2 Jan 2023
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial BleedingStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Mahmud, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759089
- Sponsor's protocol ID
- MahmudT
- Other IDs
- No funding
- Acronym
- CATER
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07759089
- Acronym / sponsor ID
- CATER / MahmudT
- Conditions
- Endobronchial Bleeding, Hemoptysis
- Keywords
- ranexamic acid, adrenaline, Endobronchial bleeding, Bronchoscopy, endobronchial biopsy, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 11 Aug 2026 (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.
During bronchoscopy (a procedure using a thin, flexible camera to look inside the airways), doctors sometimes take small tissue samples (biopsies) to diagnose lung conditions. This can cause bleeding in the airway. Doctors currently use a medicine called adrenaline to stop this bleeding, but it doesn't always work, and bleeding can come back afterward. Another medicine, tranexamic acid, may work better because it helps blood clot and stay clotted, rather than just narrowing the blood vessels.
This study compared tranexamic acid and adrenaline, both given directly onto the bleeding site through the bronchoscope, in patients who developed moderate bleeding after a biopsy. The goal was to find out which medicine stopped the bleeding better right away, and which one was less likely to let the bleeding start again within 30 minutes.
Detailed description
This was a randomized controlled trial conducted at the Department of Pulmonology, Shaikh Zayed Hospital, Federal Postgraduate Medical Institute, Lahore, Pakistan, over a 12-month period. Adult patients undergoing diagnostic flexible bronchoscopy with endobronchial forceps biopsy who developed moderate post-biopsy bleeding (bleeding that obscured the bronchoscopic view and required repeated suctioning and endoscopic intervention, but without hemodynamic instability) were randomized by lottery method into two equal groups (n=38 each).
Group A received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; 0.05 mg/mL), and Group B received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; 25 mg/mL). The assigned drug was instilled directly onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, with administration repeated up to three times at 30-second intervals if bleeding persisted.
The primary outcome was immediate hemostasis, defined as cessation of oozing and/or formation of a stable clot within 90 seconds of drug instillation. The secondary outcome was rebleeding within 30 minutes of initial hemostasis, assessed by repeat bronchoscopic inspection. If bleeding persisted beyond 90 seconds despite maximal drug administration, this was classified as treatment failure, and rescue measures (cold saline, crossover drug instillation, wedge tamponade, electrocautery, or argon plasma coagulation) were used.
Demographic and clinical data (age, gender, BMI, smoking status, symptom duration, diabetes, hypertension) were recorded, and stratified subgroup analyses were performed. Statistical analysis used the Chi-square test for intergroup comparisons, with p≤0.05 considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenaline Group | Active comparator | Drug: AdrenalinePatients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; concentration 0.05 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted. |
| Tranexamic Acid Group | Experimental | Drug: Tranexamic AcidPatients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; concentration 25 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of any age and gender undergoing diagnostic flexible bronchoscopy for suspected benign or malignant airway disease
- Required endobronchial forceps biopsy during the procedure
- Developed moderate endobronchial bleeding following biopsy (defined as bleeding that obscured the bronchoscopic view, required repeated suctioning to clear the airway, and required endoscopic intervention for hemostasis, but remained hemodynamically stable)
Key exclusion criteria (10 listed)
- Severe bleeding (requiring instillation of ice-cold saline, bronchoscopic tamponade, electrocautery, or argon plasma coagulation)
- Life-threatening bleeding (requiring endotracheal intubation, or spontaneous hemoptysis of more than 100-150 mL per hour)
- Contraindications to bronchoscopy, including:
- Bleeding diathesis with raised INR or platelet count less than 50,000/mm³
- Unstable coronary artery disease
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 |
|---|---|---|
| Adrenaline1 mg adrenaline diluted in 20 mL normal saline (0.05 mg/mL), administered topically via bronchoscope working channel in 5 mL aliquots, up to 3 applications at 30-second intervals. | Drug | Adrenaline Group |
| Tranexamic Acid500 mg tranexamic acid diluted in 20 mL normal saline (25 mg/mL), administered topically via bronchoscope working channel in 5 mL aliquots, up to 3 applications at 30-second intervals. | Drug | Tranexamic Acid Group |
Primary outcome
Immediate Hemostasis (Bleeding Cessation)
Time frame: Within 90 seconds of drug instillation
Immediate bleeding control, defined as direct bronchoscopic observation of cessation of oozing and/or formation of a stable clot at the bleeding site, assessed within 90 seconds of drug instillation. If bleeding persisted beyond 90 seconds despite maximal drug administration (up to 3 applications), this was classified as treatment failure and rescue hemostatic measures were initiated.
1 secondary outcome
Rebleeding
Time frame: Within 30 minutes of initial hemostasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Endobronchial Bleeding
Active, not recruitingPhase 3
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Hemorrhage Lung, Endobronchial Mass
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenaline and Tranexamic Acid in people with Endobronchial Bleeding and Hemoptysis, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
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 3 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: finished, as of the sponsor's last update on 11 Aug 2026. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Hemostasis (Bleeding Cessation) (time frame: Within 90 seconds of drug instillation). 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 11 Aug 2026.