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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02781597
Other study ID # HEMOP-TXA 23
Secondary ID
Status Completed
Phase Phase 3
First received April 17, 2016
Last updated May 20, 2016
Start date January 2011
Est. completion date June 2012

Study information

Verified date May 2016
Source Postgraduate Institute of Medical Education and Research
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Placebo
Patients will receive 0.9% normal saline

Locations

Country Name City State
India Post graduate institute of medical education and research Chandigarh UT

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in severity of hemoptysis Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours. day1 and day2 No
Secondary Intervention needed Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No) 2 days Yes
Secondary Blood transfusion needed Number of blood transfused 2 days No
Secondary Hospital stay Number of days of hospital stay Through study completion, an average of 1 year No
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