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

Not yet recruiting

Conditions: Diseases of bronchus, not elsewhere classified,

Registration Number: CTRI/2023/05/052223

Lead Sponsor: Pulmonary Medicine Department of AIIMS Jodhpur

Brief Summary: Allpatients satisfying the inclusion criteria during the study period will beenrolled in the study after obtaining written informed consent. A routine clinicalexamination will be done and all the baseline characteristics will be recorded. Blood investigations like CBC, LFT, and KFT,baseline ECG will be done along with coagulation parameters like PT/PTT/INR andviral markers for HIV, Hep-B and Hep-C. Data will be collected according to a predesigned proforma. Flexible bronchoscopy will beperformed in the bronchoscopy suite by two experienced bronchoscopists, onewill be the lead bronchoscopist and other will be assisting bronchoscopist. Itwill be performed via either the oropharyngeal or nasopharyngeal route underconscious sedation and local anaesthesia. Patient will be sedated withintravenous injection of midazolam and fentanyl. Pharyngeal anaesthesia with10% lidocaine spray will be applied before bronchoscopy. 2% lidocaine solutionwill be instilled through the bronchoscope using spray-as-you go technique tothe trachea and main airways for local anaesthesia. Bloodpressure, heart rate, SPO2, electrocardiogram, and consciousness level will becontinuously monitored during the procedure. Bronchoscopy shall be performed usingOlympus (BF 1TH 190 or BF 1T150) bronchoscope. Through the working channel ofthe bronchoscope, 500 mg TXA (500 mg/5 mL given in 5 ml of saline, or coldsaline (4Â°C, 10 ml of 0.9% NaCl) would be instilled as per the randomization sequencein the target lobar bronchus or endobronchial lesion. After 2â€“3 min, forcepsbiopsy specimens will be obtained with the aim of a minimum of four biopsies. Wewill use dedicated biopsy forceps for EBB and TBLB. Bleeding severity shall begraded by the assisting bronchoscopist, who will be blinded for prophylactic agent.Assisting bronchoscopist will be asked to come inside the bronchoscopy suite onlyafter 2-3 minutes of instillation of prophylactic agent. Suctioning will beperformed using a wall-mounted suction system. Need for bleeding controlmeasures (i.e. cold saline, topical adrenaline or wedge tamponade) will berecorded for all procedures. Patient will be observed in a recovery area for atleast 2 hours after bronchoscopy, routine chest X-ray will be performed beforedischarge, in cases of transbronchial lung biopsy or as per clinical indication.Follow-up telephone calls and medical record reviews will be performed at 1 monthto detect any adverse events such as myocardial infarction, stroke, seizures, deepvein thrombosis, or pulmonary embolism.

Thebleeding severity will be graded by the bronchoscopist using visual analogscale (VAS; 1 - very mild, 10 â€“ very severe). and BTS classification ofbleeding severity.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

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

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.	6 months, 12 months, 18 months

Secondary Outcome Measures

Name	Time	Method
1.The number of biopsies obtained	2.Need of additional measures (cold saline, ADR, Balloon tamponade) to achieve haemostasis in case of uncontrolled bleeding.

Trial Locations

Locations (1): Pulmonary medicine department, AIIMS jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
Pulmonary medicine department, AIIMS jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
AMARENDRA KUMAR SHUKLA
Principal investigator
7307632248
shuklaamarendrakumar@gmail.com