Efficacy of Tranexamic Acid in Hemoptysis

NCT02781597 | Completed Phase 3 DMC

• 1 other identifier: HEMOP-TXA 23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoptysis

Keywords

Hemoptysis; Tranexamic acid; VAS score

Outcome Measures

Primary Outcomes (1)

• Change in severity of hemoptysis

  Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.

  day1 and day2

Secondary Outcomes (3)

• Intervention needed

  2 days

• Blood transfusion needed

  2 days

• Hospital stay

  Through study completion, an average of 1 year

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid 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

Also known as: TA

Tranexamic acid

Placebo DRUG

Patients will receive 0.9% normal saline

Also known as: Placebo control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ongoing hemoptysis
• Age: 18 years and above

You may not qualify if:

• 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)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post graduate institute of medical education and research

Chandigarh, Uttarakhand, 160012, India

Location

MeSH Terms

Conditions

Hemoptysis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: junior resident

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: May 24, 2016
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)