Efficacy of Tranexamic Acid in Hemoptysis

NCT ID: NCT02781597

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Hemoptysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive 0.9% normal saline

Interventions

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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

Intervention Type DRUG

Placebo

Patients will receive 0.9% normal saline

Intervention Type DRUG

Other Intervention Names

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TA Placebo control

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Balaji Laxminarayanshetty Bellam

junior resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Post graduate institute of medical education and research

Chandigarh, Uttarakhand, India

Site Status

Countries

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India

Other Identifiers

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HEMOP-TXA 23

Identifier Type: -

Identifier Source: org_study_id

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