se of nebulised versus injected Tranexamic acid in treating blood in sputum:a randomised controlled trial.
- Conditions
- Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere
- Registration Number
- CTRI/2021/10/037079
- Lead Sponsor
- Vasudha D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All adult patients more than 18 years of age, attending the emergency medicine department with nonmassive haemoptysis.(haemoptysis less than 200ml/day with no haemodynamic instability. Patients with more than one episode of haemoptysis (spitting of blood)in the last 24 hours.
1.Massive haemoptysis( >200ml in the last 24 hours)with haemodynamic instability and/or respiratory obstruction,
2. Patients with haematemesis.
3.Patients on antiplatelet drug therapy,
4.Patients with pre-existing coagulation abnormalities,
5.Known hypersensitivity to the study drug,
6.Impaired renal functions (as evidenced by serum creatinine level more than 3mg/dl or need for renal replacement therapy),
7.Impaired hepatic function(serum bilirubin more than 2mg/dl,aspartate amino transferase greater than 3 times the normal,INR greater than 2).In case of subjects already started on treatment ,whose renal and hepatic function tests as detected by investigations above are impaired, they will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Among the patients undergoing treatment for hemoptysis, to compare the efficacy of nebulised TXA to that of intravenous TXA in <br/ ><br>1. successful cessation of bleeding at 8 hours post administration, <br/ ><br>2. amount of blood lost by expectoration per day <br/ ><br>3. total dose of TXA administered for treatment success. <br/ ><br>Timepoint: Initial 8 hours and 8th hourly in the next 72 hours.
- Secondary Outcome Measures
Name Time Method Complications, duration of hospital stay,need for invasive procedures, number of transfusions,to assess for relapse in bleeding,as assessed by increasing episodes of haemoptysis,fall in Hb level to below 10g/dl or falls more than 2g/dl from the baseline value.Timepoint: Initial 8 hours and 8th hourly in the next 72 hours.