Efficacy of Tranexamic Acid in Hemoptysis

Sponsor

Postgraduate Institute of Medical Education and Research (Other)

Overall Status

Completed

CT.gov ID

NCT02781597

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemoptysis	Drug: Tranexamic Acid Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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 Other Names: TA
Placebo Comparator: 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.	Drug: Placebo Patients will receive 0.9% normal saline Other Names: Placebo control

Arm

Intervention/Treatment

Active Comparator: 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.

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

Other Names:

Placebo Comparator: 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.

Drug: Placebo

Patients will receive 0.9% normal saline

Other Names:

Placebo control

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Post graduate institute of medical education and research	Chandigarh	UT	India	160012

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Balaji Laxminarayanshetty Bellam, junior resident, Postgraduate Institute of Medical Education and Research

ClinicalTrials.gov Identifier:

NCT02781597

Other Study ID Numbers:

HEMOP-TXA 23

First Posted:

May 24, 2016

Last Update Posted:

May 24, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Balaji Laxminarayanshetty Bellam, junior resident, Postgraduate Institute of Medical Education and Research

Hemoptysis

Tranexamic acid

VAS score

Additional relevant MeSH terms:

Hemoptysis

Tranexamic Acid

Study Results

No Results Posted as of May 24, 2016