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

NCT07481682 | Completed

• 1 other identifier: 36264MS203/6/23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to detect the impact of inhaled Tranexamic acid® in pulmonary hemorrhage in pediatric intensive care unit.

Conditions

Tranexamic Acid; Pulmonary Hemorrhage; Pediatric; Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

• Cessation of pulmonary hemorrhage

  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

  Incidence of adverse effects was recorded.

  48 hours of starting inhaled tranexamic acid

Secondary Outcomes (2)

• In-hospital mortality

  48 hours of starting inhaled tranexamic acid

• Length of hospital stay

  Till the discharge from the hospital (Up to 2 weeks)

Study Arms (2)

Group I

EXPERIMENTAL

Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy.

Drug: Tranexamic acid + conventional therapy.

Group II

EXPERIMENTAL

Patients received conventional systemic Tranexamic acid (TXA) alone.

Drug: Tranexamic acid

Interventions

Tranexamic acid + conventional therapy. DRUG

Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy.

Group I

Tranexamic acid DRUG

Patients received conventional systemic Tranexamic acid (TXA) alone.

Group II

Eligibility Criteria

• Age: 1 Month - 216 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Pediatrics, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: August 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)