Prevention of bleeding after bronchoscopic biopsy with the use of prophylactic local tranexemic acid
- Conditions
- Health Condition 1: J980- Diseases of bronchus, not elsewhere classified
- Registration Number
- CTRI/2023/05/052223
- Lead Sponsor
- Pulmonary Medicine Department of AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1.Coagulopathy: INR >1.5
2.Thrombocytopenia: platelets count < 50000
3.Anaemia: haemoglobin < 7gm/dl
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 <65mm of hg)
9.Severe hypoxemia prior to bronchoscopy start (PaO2 <60mmog hg and Spo2 <90% with Fio2 of 60% or higher)
10.Refusal to consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.The number of biopsies obtained <br/ ><br>2.Need of additional measures (cold saline, ADR, Balloon tamponade) to achieve haemostasis in case of uncontrolled bleeding. <br/ ><br>3.Assess the adverse effect of TXA. <br/ ><br>Timepoint: 6 months, 12 months, 18 months
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