NCT07212452

Brief Summary

This study compares the effect of tranexamic acid on hemoptysis when given through the conventional IV route and Through nebulization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 28, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 30, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

HemoptysisNebulizationtranexamic acid

Outcome Measures

Primary Outcomes (1)

  • Time to control hemoptysis

    In this study the time taken by tranexamic acid to acehive comolete control of hemoptysis will be compared when given through IV and nebulization.

    48 hours

Study Arms (2)

Group receiving tranexamic acid via IV route

ACTIVE COMPARATOR

Tranexamic acid has been used conventionally for hemoptysis via IV route

Drug: Tranexamic Acid (TXA)

The Group receiving tranexamic acid via nebulization

EXPERIMENTAL

Tranexamic acid when given through nebulization can be more effective than IV route in controlling hemoptysis

Drug: Tranexamic Acid (TXA)

Interventions

In this study we are comparing the effect of tranexamic acid on hemoptysis when given through IV route and nebulization

Also known as: nebulization
Group receiving tranexamic acid via IV routeThe Group receiving tranexamic acid via nebulization

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate hemoptysis \< 600ml/ 24 hours of age 12 to 80 years and both genders.
  • Patients with hemoptysis due to infective pathology.
  • Patients with hemoptysis due to malignant pathology.

You may not qualify if:

  • Patients on antiplatelet therapy or aspirin
  • Hemoptysis after penetrating lung injury e.g. firearm injury
  • Patients with history of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Gopinath B, Mishra PR, Aggarwal P, Nayaka R, Naik SR, Kappagantu V, Shrimal P, Ramaswami A, Bhoi S, Jamshed N, Sinha TP, Ekka M, Kumar A. Nebulized vs IV Tranexamic Acid for Hemoptysis: A Pilot Randomized Controlled Trial. Chest. 2023 May;163(5):1176-1184. doi: 10.1016/j.chest.2022.11.021. Epub 2022 Nov 19.

Related Links

MeSH Terms

Conditions

Hemoptysis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There is no masking as the participnats will be explained the whole process and consent would be taken for using the either route for administration of tranexamic acid
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention will be given to the participants via providing the tranexamic acide through both IV and nebulization routes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 8, 2025

Study Start

August 1, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

November 28, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations