Efficacy of Tranexamic Acid in Hemoptysis

May 20, 2016 updated by: Balaji Laxminarayanshetty Bellam, Postgraduate Institute of Medical Education and Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • UT
      • Chandigarh, UT, India, 160012
        • Post Graduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in severity of hemoptysis
Time Frame: day1 and day2
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
Time Frame: 2 days
Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No)
2 days
Blood transfusion needed
Time Frame: 2 days
Number of blood transfused
2 days
Hospital stay
Time Frame: Through study completion, an average of 1 year
Number of days of hospital stay
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 17, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMOP-TXA 23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not required at present

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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