- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781597
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
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
-
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UT
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Chandigarh, UT, India, 160012
- Post Graduate Institute of Medical Education and Research
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-
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:
- 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)
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.
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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:
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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.
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Patients will receive 0.9% normal saline
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in severity of hemoptysis
Time Frame: day1 and day2
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Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.
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day1 and day2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention needed
Time Frame: 2 days
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Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No)
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2 days
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Blood transfusion needed
Time Frame: 2 days
|
Number of blood transfused
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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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