Efficacy of Tranexamic Acid in Hemoptysis

Study Overview
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Brief Summary
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The purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding in patients of hemoptysis and also to evaluate the safety of tranexamic acid.

Detailed Description
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Hemoptysis is a common problem in India due to high incidence of tuberculosis and also due to post tubercular sequale. Hemoptysis is usually managed conservatively in mild to moderate cases and cases of massive hemoptysis are managed with more definitive treatment options like vessel embolization (bronchial/pulmonary artery) and surgery as a last option. Tranexamic acid is a antifibrinolytic used in many surgeries and trauma patients to control bleeding and it has been shown effective and safe. The purpose of the study is to evaluate the efficacy of tranexamic acid in patients with hemoptysis in controlling bleeding.

Official Title
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Efficacy of Tranexamic Acid in Controlling Hemoptysis, A Randomized Control Trial

Conditions
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Hemoptysis

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ongoing hemoptysis Age: 18 years and above Exclusion Criteria: Pregnant females Females on oral contraceptives Patients on antifibrinolytics Patients with known drug allergy Patients with renal failure Patients requiring intubation during study period Patients with Massive hemoptysis (>600 ml/24 hrs)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid<br>All patients will receive basic resuscitative measures and standard treatment like assessment and management of Airway, breathing, circulation, antitussives, and blood products. Patients in group T will receive Inj Tranexamic acid in a loading dose of 1 g over 10 min followed by an infusion of 1 g over 8 h. | Drug: Tranexamic Acid<br>* Patients will receive Inj Tranexamic acid, in IV in a loading dose of 1 g over 10 min followed by an infusion of 1 g over 8 h in 500ml normal saline<br>* Other names: TA;|
| Placebo Comparator: Placebo<br>All patients will receive basic resuscitative measures and standard treatment like assessment and management of Airway, breathing, circulation, antitussives, and blood products. Patients will receive 0.9% normal saline instead of Tranexamic acid. | Drug: Placebo<br>* Patients will receive 0.9% normal saline<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of hemoptysis | Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours. | day1 and day2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention needed | Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No) | 2 days | 
| Blood transfusion needed | Number of blood transfused | 2 days | 
| Hospital stay | Number of days of hospital stay | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoptysis, Tranexamic acid, VAS score