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NCT Number: NCT02781597

Efficacy of Tranexamic Acid in Hemoptysis

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.

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Key information

Conditions

Hemoptysis Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Post graduate institute of medical education and research

Chandigarh, Uttarakhand, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

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

Drug

Patients will receive 0.9% normal saline

Other names: Placebo control

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. Blood transfusion needed

    Time frame: 2 days

    Number of blood transfused

  3. Hospital stay

    Time frame: Through study completion, an average of 1 year

    Number of days of hospital stay

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 24, 2016
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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