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Efficacy of Tranexamic Acid in Hemoptysis

Primary Purpose

Hemoptysis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemoptysis focused on measuring Hemoptysis, Tranexamic acid, VAS score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Post graduate institute of medical education and research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in severity of hemoptysis
Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.

Secondary Outcome Measures

Intervention needed
Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No)
Blood transfusion needed
Number of blood transfused
Hospital stay
Number of days of hospital stay

Full Information

First Posted
April 17, 2016
Last Updated
May 20, 2016
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02781597
Brief Title
Efficacy of Tranexamic Acid in Hemoptysis
Official Title
Efficacy of Tranexamic Acid in Controlling Hemoptysis, A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoptysis
Keywords
Hemoptysis, Tranexamic acid, VAS score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TA
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo control
Intervention Description
Patients will receive 0.9% normal saline
Primary Outcome Measure Information:
Title
Change in severity of hemoptysis
Description
Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.
Time Frame
day1 and day2
Secondary Outcome Measure Information:
Title
Intervention needed
Description
Whether intervention needed to control hemoptysis, in the form of bronchial/pulmonary artery embolization or surgery.(Yes/No)
Time Frame
2 days
Title
Blood transfusion needed
Description
Number of blood transfused
Time Frame
2 days
Title
Hospital stay
Description
Number of days of hospital stay
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Post graduate institute of medical education and research
City
Chandigarh
State/Province
UT
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not required at present

Learn more about this trial

Efficacy of Tranexamic Acid in Hemoptysis

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