An interventional study of Adrenaline and Tranexamic Acid in Endobronchial Bleeding and Hemoptysis, sponsored by Sheikh Zayed Federal Postgraduate Medical Institute. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Sheikh Zayed Federal Postgraduate Medical Institute · Not applicable, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's enrollment of 76 is close to the median of 73 across 20 interventional studies indexed under Hemoptysis.
Browse Hemoptysis studies →Sheikh Zayed Federal Postgraduate Medical Institute is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to bronchoscopy, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Adrenaline
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.
Drug: Tranexamic Acid
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.
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.
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.
Time frame: Within 90 seconds of drug instillation
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.
Time frame: Within 30 minutes of initial hemostasis
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Tranexamic Acid
Sheikh Zayed Federal Postgraduate Medical Institute