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Enrolling by invitationNCT07845747Updated Sep 29, 2026

Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis

A Phase 4 interventional study of Tranexamic Acid in Hemoptysis, sponsored by Dow University of Health Sciences. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Dow University of Health Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
154
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemoptysis

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (estimated)

Study arms

  • Experimental
    Inhaled Tranexamic Acid

    Drug: Tranexamic Acid

  • Experimental
    Intravenous Tranexamic Acid

    Drug: Tranexamic Acid

Interventions

  • DrugTranexamic Acid

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

05

What researchers measure

Primary outcomes

  1. Significant reduction in hemoptysis

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

    Time frame: 2 hours after drug administration

Secondary outcomes

  1. Amount of hemoptysis reduction

    Change in amount of blood loss due to hemoptysis after treatment.

    Time frame: 30 minutes, 6 hours, 12 hours, and 24 hours after drug administration

  2. Side effects of Tranexamic Acid

    Presence of adverse effects after administration of Tranexamic Acid, including redness, burning, pain, swelling, or other reported side effects.

    Time frame: Within 24 hours after drug administration

06

Study locations

1 site
  • Ward-2 Ojha Institute of Chest Diseases (OICD), Dow University of Health Sciences
    Karachi, Sindh, Pakistan
07

Registry details

Key details

Study ID
NCT07845747
Lead sponsor
Dow University of Health Sciences
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Sep 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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