Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis

NCT07845747 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: IRB-4175/DUHS/APPROVAL/2025
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi. It will be conducted over six months after obtaining necessary approvals. We will recruit 154 patients aged 18-60 years, regardless of gender, who will present with complain of hemoptysis. Patients will be selected through a non-probability consecutive sampling method, where each eligible patient will be approached for participation. Participants will be randomly assigned to one of two groups using a lottery method:

• Group A will receive 500 mg of inhaled Tranexamic acid three times a day.
• Group B will receive 500 mg of intravenous Tranexamic acid three times a day. Once patients give consent for participation, we will gather detailed medical history. Blood tests and X-rays will be done to assess each patient's health status. We will then monitor the amount of blood expectorated after 30 minutes, 6 hours, 12 hours, and 24 hours post-administration. We will also observe any side effects from the treatment.

Conditions

Hemoptysis

Outcome Measures

Primary Outcomes (1)

• Significant reduction in hemoptysis

  Proportion of patients achieving more than 50% reduction in hemoptysis blood volume after administration of Tranexamic Acid.

  2 hours after drug administration

Secondary Outcomes (2)

• Amount of hemoptysis reduction

  30 minutes, 6 hours, 12 hours, and 24 hours after drug administration

• Side effects of Tranexamic Acid

  Within 24 hours after drug administration

Study Arms (2)

Inhaled Tranexamic Acid

EXPERIMENTAL

Drug: Tranexamic Acid

Intravenous Tranexamic Acid

EXPERIMENTAL

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Tranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis

Inhaled Tranexamic Acid; Intravenous Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-60 years.
• Patients diagnosed with hemoptysis based on the defined operational definition.
• Patients who provide written informed consent to participate in the study.

You may not qualify if:

• Patients with known hypersensitivity to Tranexamic acid.
• Hemodynamically unstable patients.
• Patients requiring immediate interventional procedure or mechanical ventilation.
• Patients with active thromboembolic events (pulmonary embolism, deep vein thrombosis, ischemic stroke).
• Patients with a history of thromboembolic disease.
• Patients with disseminated intravascular coagulation (DIC) without heparin.
• Patients with severe renal impairment, gross upper urinary tract hematuria, recent vascular stent/graft, or subarachnoid hemorrhage.
• Pregnant and breastfeeding women.
• Patients who are not willing to participate in the study.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Ward-2 Ojha Institute of Chest Diseases (OICD), Dow University of Health Sciences

Karachi, Sindh, Pakistan

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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

PA (1)