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Prevention of bleeding after bronchoscopic biopsy with the use of prophylactic local tranexemic acid

â??Efficacy of prophylactic topical instillation of tranexamic acid versus cold saline for prevention of iatrogenic bleeding after flexible bronchoscopic biopsy: a double blind randomised control trialâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052223
Enrollment
70
Registered
2023-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J980- Diseases of bronchus, not elsewhere classified

Interventions

Intervention1: Tranexamic acid: Dose- 500 mg TXA (500 mg/5 mL given in 5 ml of saline before bronchoscopic endobronchial and transbronchial biopsy. Route- Topical through working channel of bronchosco

Sponsors

Pulmonary Medicine Department of AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. All patients requiring EBB or TBLB and fulfilling the fitness to undergo flexible bronchoscopy. 3. Patients providing prior written informed consent

Exclusion criteria

Exclusion criteria: 1. Coagulopathy: INR >1.5 2. Thrombocytopenia: platelets count 3. Anaemia: haemoglobin 4. Ongoing treatment with direct oral anticoagulant agents (DOAC), low molecular weight heparin (LMWH) or dual antiplatelet therapy (DAPT) 5. Patients with unstable or recent coronary heart disease or cerebrovascular disease 6. Decompensated liver disease, end stage kidney disease 7. Uncontrolled arrhythmia. 8. Hemodynamic instability and cardiovascular decompensation: patients with hypotension (MAP 9. Severe hypoxemia prior to bronchoscopy start (PaO2 10. Refusal to consent

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of prophylactic topical instillation of TXA with cold saline for prevention or reduction of bleeding after endobronchial or transbronchial forceps biopsy during flexible bronchoscopy.Timepoint: 6 months, 12 months, 18 months—

Secondary

MeasureTime frame
1. The number of biopsies obtained 2. Need of additional measures (cold saline, ADR, Balloon tamponade) to achieve haemostasis in case of uncontrolled bleeding. 3. Assess the adverse effect of TXA. Timepoint: 6 months, 12 months, 18 months—

Countries

India

Contacts

Public ContactAmarendra Kumar Shukla

Pulmonary medicine department AIIMS Jodhpur

nishant97@gmail.com7307632248

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026