Efficacy of Tranexamic Acid in Hemoptysis

Phase 3

Completed

• Conditions: Hemoptysis
• Interventions: Drug: Placebo; Drug: Tranexamic Acid

• Registration Number: NCT02781597
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2016-04-17
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-20
• Last Update Submitted: 2016-05-20
• Study First Posted: 2016-05-24
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Acute ongoing hemoptysis
2. Age: 18 years and above

Exclusion Criteria

1. Pregnant females
2. Females on oral contraceptives
3. Patients on antifibrinolytics
4. Patients with known drug allergy
5. Patients with renal failure
6. Patients requiring intubation during study period
7. Patients with Massive hemoptysis (>600 ml/24 hrs)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Tranexamic acid	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
Change in severity of hemoptysis	day1 and day2	Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Post graduate institute of medical education and research; 🇮🇳 Chandigarh, UT, India