Efficacy of Tranexamic Acid in Hemoptysis

Hemoptysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781597
• Other study ID #: HEMOP-TXA 23
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2016
• Last updated: May 20, 2016
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemoptysis

Intervention

Drug:
• Tranexamic Acid
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
• Placebo
Patients will receive 0.9% normal saline

Locations

Country	Name	City	State
India	Post graduate institute of medical education and research	Chandigarh	UT

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of hemoptysis	Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.	day1 and day2	No
Secondary	Intervention needed	Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No)	2 days	Yes
Secondary	Blood transfusion needed	Number of blood transfused	2 days	No
Secondary	Hospital stay	Number of days of hospital stay	Through study completion, an average of 1 year	No