Impact of Inhaled Tranexamic Acid in Pulmonary Hemorrhage in Pediatric Intensive Care Unit

March 15, 2026 updated by: Shrouk Akram Osman Nasr, Tanta University
This study aimed to detect the impact of inhaled Tranexamic acid® in pulmonary hemorrhage in pediatric intensive care unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pulmonary hemorrhage, often manifested as hemoptysis, can be a severe and life-threatening condition.

Tranexamic acid (TXA)® is a lysine analog that prevents the conversion of plasminogen to plasmin and inhibits plasmin's binding to fibrin, stabilizing the fibrin matrix and reducing bleeding.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 1 to 216 months.
  • Both sexes.
  • Patients with pulmonary hemorrhage.

Exclusion Criteria:

  • Disseminated Intravascular Coagulation (DIC).
  • Laryngeal oedema.
  • Laryngeal web.
  • Contraindications to tranexamic acid include arterial thrombosis, pre-existing coagulopathy, or oral anticoagulant treatment.
  • Patients with traumatic lesions such as hemothorax.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy.
Drug: Tranexamic acid + conventional therapy.
Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy.
Experimental: Group II
Patients received conventional systemic Tranexamic acid (TXA) alone.
Drug: Tranexamic acid
Patients received conventional systemic Tranexamic acid (TXA) alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cessation of pulmonary hemorrhage
Time Frame: 48 hours of starting inhaled tranexamic acid
The cessation of pulmonary hemorrhage within 48 hours of starting inhaled tranexamic acid was recorded.
48 hours of starting inhaled tranexamic acid
Incidence of adverse effects
Time Frame: 48 hours of starting inhaled tranexamic acid
Incidence of adverse effects was recorded.
48 hours of starting inhaled tranexamic acid

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 48 hours of starting inhaled tranexamic acid
Incidence of in-hospital mortality was recorded.
48 hours of starting inhaled tranexamic acid
Length of hospital stay
Time Frame: Till the discharge from the hospital (Up to 2 weeks)
Length of hospital stay was recorded from the admission till the discharge from the hospital.
Till the discharge from the hospital (Up to 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264MS203/6/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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