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Trial record 52 of 419 for:    TRANEXAMIC ACID

Efficacy of Tranexamic Acid in Hemoptysis

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ClinicalTrials.gov Identifier: NCT02781597
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Balaji Laxminarayanshetty Bellam, Postgraduate Institute of Medical Education and Research

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo control




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781597


Locations
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India
Post graduate institute of medical education and research
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Balaji Laxminarayanshetty Bellam, junior resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02781597     History of Changes
Other Study ID Numbers: HEMOP-TXA 23
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not required at present
Keywords provided by Balaji Laxminarayanshetty Bellam, Postgraduate Institute of Medical Education and Research:
Hemoptysis
Tranexamic acid
VAS score
Additional relevant MeSH terms:
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Tranexamic Acid
Hemoptysis
Lung Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants