Tranexamic AcidNCT07481682
Impact of Inhaled Tranexamic Acid in Pulmonary Hemorrhage in Pediatric Intensive Care Unit
A study testing Tranexamic acid + conventional therapy. and Tranexamic acid in people with Tranexamic Acid and Pulmonary Hemorrhage, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to detect the impact of inhaled Tranexamic acid® in pulmonary hemorrhage in pediatric intensive care unit. Read more about this study
- Who is it for?
- Ages 1 month to 216 months
- Conditions the study is for
- Tranexamic Acid, Pulmonary Hemorrhage, Pediatric
- What is being tested?
- Tranexamic acid + conventional therapy. and Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 216 months
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 1 to 216 months.
- Both sexes.
- Patients with pulmonary hemorrhage.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to detect the impact of inhaled Tranexamic acid® in pulmonary hemorrhage in pediatric intensive care unit.
Read the 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.
- Conditions
- Tranexamic Acid, Pulmonary Hemorrhage, Pediatric, Intensive Care Unit
- Being tested
- Tranexamic acid + conventional therapy., Tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid + conventional therapy.Drug
Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy.
Tranexamic acidDrug
Patients received conventional systemic Tranexamic acid (TXA) alone.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy. Receives: Drug: Tranexamic acid + conventional therapy. |
| Group II | Experimental | Patients received conventional systemic Tranexamic acid (TXA) alone. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of pulmonary hemorrhage
The cessation of pulmonary hemorrhage within 48 hours of starting inhaled tranexamic acid was recorded.
Measured: 48 hours of starting inhaled tranexamic acid
Incidence of adverse effects
Incidence of adverse effects was recorded.
Measured: 48 hours of starting inhaled tranexamic acid
Secondary outcomes (2)
In-hospital mortality
Incidence of in-hospital mortality was recorded.
Measured: 48 hours of starting inhaled tranexamic acid
Length of hospital stay
Length of hospital stay was recorded from the admission till the discharge from the hospital.
Measured: Till the discharge from the hospital (Up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Aug 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic AcidStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Akram Osman Nasr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481682
- Sponsor's protocol ID
- 36264MS203/6/23
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inhaled Tranexamic Acid in Pulmonary Hemorrhage in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07481682
- Acronym / sponsor ID
- 36264MS203/6/23
- Conditions
- Tranexamic Acid, Pulmonary Hemorrhage, Pediatric, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to detect the impact of inhaled Tranexamic acid® in pulmonary hemorrhage in pediatric intensive care unit.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Tranexamic acid + conventional therapy.Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy. |
| Group II | Experimental | Drug: Tranexamic acidPatients received conventional systemic Tranexamic acid (TXA) alone. |
Who may qualify
- Ages
- 1 month to 216 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age from 1 to 216 months.
- Both sexes.
- Patients with pulmonary hemorrhage.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid + conventional therapy.Patients received inhaled or endotracheally instilled Tranexamic acid (TXA) in addition to conventional therapy. | Drug | Group I |
| Tranexamic acidPatients received conventional systemic Tranexamic acid (TXA) alone. | Drug | Group II |
Primary outcome
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.
Incidence of adverse effects
Time frame: 48 hours of starting inhaled tranexamic acid
Incidence of adverse effects was recorded.
2 secondary outcomes
In-hospital mortality
Time frame: 48 hours of starting inhaled tranexamic acid
Length of hospital stay
Time frame: Till the discharge from the hospital (Up to 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid + conventional therapy. and Tranexamic acid in people with Tranexamic Acid and Pulmonary Hemorrhage, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of pulmonary hemorrhage (time frame: 48 hours of starting inhaled tranexamic acid). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.