HemoptysisPhase 3TXA-NEBNCT05648656
TXA Nebulization for the Treatment of Hemoptysis
A Phase 3 study testing TXA Nebulization and 0.9% NS Nebulization in people with Hemoptysis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Hemoptysis is a common presentation in medical emergency. Prompt medical therapy, bronchoscopic and endovascular procedures remains the cornerstone of management for both diagnostic as well as therapeutic purpose in hemoptysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoptysis
- What is being tested?
- TXA Nebulization and 0.9% NS Nebulization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 3 Feb 2022to 31 Jan 2023
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cases of active hemoptysis
- irrespective of gender
- age≥ 18 years
Who cannot join
- Massive hemoptysis
- Pregnancy
- Drug allergy to TXA4
- Renal failure
- Receiving Oral Contraceptive Pills.
- Already on blood thinner
- Not willing for consent.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Deba Prasad dhibar, MD, +911722756670, dhibar.dp@pgimer.edu.in
About this study
Official title: Efficacy of TXA Nebulization for the Treatment of Hemoptysis: A Randomized Controlled Clinical Trial
Hemoptysis is a common presentation in medical emergency. Prompt medical therapy, bronchoscopic and endovascular procedures remains the cornerstone of management for both diagnostic as well as therapeutic purpose in hemoptysis. Priority is given for medical management to achieve hemostasis and prevent aspiration as well as treatment of underlying etiology, before undertaking any definitive bronchoscopic or endovascular intervention. While majority of the patients are managed successfully by prompt medical therapy, only the refractory cases and life-threatening hemoptysis need more definitive procedures like DSA guided bronchial artery embolization and bronchoscopic procedures like endobronchial biocompatible glue, endobronchial embolization using silicone spigots, endobronchial stents, laser photocoagulation. Tranexamic acid is an anti-fibrinolytic agent which prevent breakdown of fibrin clots, thus helping in clot stabilization and controlling bleeding. As a medical therapy Tranexamic Acid is used for bleeding control in hemoptysis as well as other surgical or traumatic bleeding. Previously conducted institutional study comparing IV infusion of TXA to placebo in patients with sub massive hemoptysis showed results favoring TXA over placebo in terms of decreasing frequency \& quantity of hemoptysis, duration of hospital stay and need for DSA/ broncoscopic/ surgical intervention and blood transfusion (1). While the oral and IV routes have been most commonly studied, use of novel approaches like aerosolized TXA and endobronchial instillation of TXA during bronchoscopy have showed positive results in achieving hemostasis in hemoptysis (2). A recently conducted RCT, to assess the effectiveness of TXA nebulization in sub-massive hemoptysis concluded that nebulized TXA is effective in reducing the frequency and quantity of hemoptysis. Nebulized TXA was also found to be safe as no severe ADR was noted during its use as per previous RCT as well as multiple case reports.
However, because of limited number of research with small sample size and barring some case reports evidence for the use of nebulized TXA is limited in hemoptysis. In hemoptysis nebulized form of TXA is supposed to reach local site of bleeding (lung/ airway) promptly at a higher concentration leading to rapid control of hemoptysis. So, this study has been planned to evaluate further this novel approach of TXA nebulization for the management of hemoptysis. Similarly, data regarding adverse drug reaction related to TXA nebulization is also limited. This study will produce additional information regarding efficacy, safety and ADR related to TXA nebulization.
- Conditions
- Hemoptysis
- Being tested
- TXA Nebulization, 0.9% NS Nebulization
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXA NebulizationDrug
Nebulization with TXA 500mg/ 5mL 8 hourly for 2 days plus standard care of therapy
0.9% NS NebulizationOther
Nebulization with 0.9% normal saline (NS) 5mL 8 hourly for 2 days plus standard care of therapy
| Study group | Role | What they receive |
|---|---|---|
| TXA | Active comparator | Nebulization with TXA 500mg/ 5mL 8 hourly for 2 days. Receives: Drug: TXA Nebulization |
| Control | Placebo comparator | Nebulization with 0.9%normal saline 5mL 8 hourly for 2 days Receives: Other: 0.9% NS Nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hemoptysis
Number of episode of hemoptysis per day will be compared at baseline and day 2 (48 hours)
Measured: 48 hours
Quantity of hemoptysis
Through collection of expectorated blood, quantityofhemoptysis per day will be compared at baseline and day2 (48hours) .
Measured: 48 hours
Visual analogue scale (VAS)
Visual subjective assessment by the patient will be used to compare the amount of hemoptysis at baseline and day 2 (48 hours). VAS will be presented to the patients as a 100 mm line anchored by description with 'no-hemoptysis' at one end and 'worst imaginable hemoptysis' on the other end. Patients will be asked to mark a point on the 100 mm line to indicate the severity.
A millimeter scale will be used to measure the score and this will provide 0-100 levels of hemoptysis and the score increases with increasing severity.
Measured: 48 hours
Secondary outcomes (7)
Adverse drug events
Frequency/number of adverse drug events will be compared between the groups.
Measured: 48 hours
Resolution of hemoptysis
Resolution of hemoptysis is defined as no episode of hemoptysis containing fresh blood sustained for at least 48 hours following cessation of hemoptysis. The rate of resolution of hemoptysis will be compared between the groups.
Measured: 48 Hours
Need for intervention
The overall the rate of the need for therapeutic interventional procedures (BAE, bronchoscopic procedures), to achieve hemostasis, will be compared between the study and control group.
Measured: 48 Hours
Need for blood transfusion
The percentage of patients requiring blood transfusion as well as the mean number of PRBCs transfused will be compared between the groups.
Measured: 48 Hours
Duration of hospital stay
The total duration of hospital stay (from the day of admission to the day of discharge or death) will be compared between both the groups.
Measured: 4 weeks
Mortality
All patients will be followed up at day 28, physically or telephonically to assess the mortality as well as their well-being. The rate of mortality will be compared between the groups.
Measured: 4 weeks
Recurrence of hemoptysis
Recurrence will be defined as fresh episode of hemoptysis after resolution during 28 days follow-up. The rate of recurrence of hemoptysis will be compared between the groups.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start3 Feb 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648656
- Sponsor's protocol ID
- INT/IEC/2021/SPL-1634
- Acronym
- TXA-NEB
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrawal A, Dhibar DP, Prakash A, Sreedhara BC, Muthu V, Pannu AK. Efficacy and safety of tranexamic acid nebulization to control bleeding of hemoptysis: The TXA-NEB randomized controlled clinical trial. Indian J Pharmacol. 2025 Nov 1;57(6):392-400. doi: 10.4103/ijp.ijp_824_25. Epub 2025 Oct 12.
PubMed 41221568
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TXA Nebulization for the Treatment of Hemoptysis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05648656
- Acronym / sponsor ID
- TXA-NEB / INT/IEC/2021/SPL-1634
- Conditions
- Hemoptysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 13 Dec 2022 (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.
Hemoptysis is a common presentation in medical emergency. Prompt medical therapy, bronchoscopic and endovascular procedures remains the cornerstone of management for both diagnostic as well as therapeutic purpose in hemoptysis. Priority is given for medical management to achieve hemostasis and prevent aspiration as well as treatment of underlying etiology, before undertaking any definitive bronchoscopic or endovascular intervention. While majority of the patients are managed successfully by prompt medical therapy, only the refractory cases and life-threatening hemoptysis need more definitive procedures like DSA guided bronchial artery embolization and bronchoscopic procedures like endobronchial biocompatible glue, endobronchial embolization using silicone spigots, endobronchial stents, laser photocoagulation. Tranexamic acid is an anti-fibrinolytic agent which prevent breakdown of fibrin clots, thus helping in clot stabilization and controlling bleeding. As a medical therapy Tranexamic Acid is used for bleeding control in hemoptysis as well as other surgical or traumatic bleeding. Previously conducted institutional study comparing IV infusion of TXA to placebo in patients with sub massive hemoptysis showed results favoring TXA over placebo in terms of decreasing frequency \& quantity of hemoptysis, duration of hospital stay and need for DSA/ broncoscopic/ surgical intervention and blood transfusion (1). While the oral and IV routes have been most commonly studied, use of novel approaches like aerosolized TXA and endobronchial instillation of TXA during bronchoscopy have showed positive results in achieving hemostasis in hemoptysis (2). A recently conducted RCT, to assess the effectiveness of TXA nebulization in sub-massive hemoptysis concluded that nebulized TXA is effective in reducing the frequency and quantity of hemoptysis. Nebulized TXA was also found to be safe as no severe ADR was noted during its use as per previous RCT as well as multiple case reports.
However, because of limited number of research with small sample size and barring some case reports evidence for the use of nebulized TXA is limited in hemoptysis. In hemoptysis nebulized form of TXA is supposed to reach local site of bleeding (lung/ airway) promptly at a higher concentration leading to rapid control of hemoptysis. So, this study has been planned to evaluate further this novel approach of TXA nebulization for the management of hemoptysis. Similarly, data regarding adverse drug reaction related to TXA nebulization is also limited. This study will produce additional information regarding efficacy, safety and ADR related to TXA nebulization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Active comparator | Drug: TXA NebulizationNebulization with TXA 500mg/ 5mL 8 hourly for 2 days. |
| Control | Placebo comparator | Other: 0.9% NS NebulizationNebulization with 0.9%normal saline 5mL 8 hourly for 2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All cases of active hemoptysis
- irrespective of gender
- age≥ 18 years
Key exclusion criteria (7 listed)
- Massive hemoptysis
- Pregnancy
- Drug allergy to TXA4
- Renal failure
- Receiving Oral Contraceptive Pills.
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 |
|---|---|---|
| TXA NebulizationNebulization with TXA 500mg/ 5mL 8 hourly for 2 days plus standard care of therapy | Drug | TXA |
| 0.9% NS NebulizationNebulization with 0.9% normal saline (NS) 5mL 8 hourly for 2 days plus standard care of therapy | Other | Control |
Primary outcome
Frequency of hemoptysis
Time frame: 48 hours
Number of episode of hemoptysis per day will be compared at baseline and day 2 (48 hours)
Quantity of hemoptysis
Time frame: 48 hours
Through collection of expectorated blood, quantityofhemoptysis per day will be compared at baseline and day2 (48hours) .
Visual analogue scale (VAS)
Time frame: 48 hours
Visual subjective assessment by the patient will be used to compare the amount of hemoptysis at baseline and day 2 (48 hours). VAS will be presented to the patients as a 100 mm line anchored by description with 'no-hemoptysis' at one end and 'worst imaginable hemoptysis' on the other end. Patients will be asked to mark a point on the 100 mm line to indicate the severity. A millimeter scale will be used to measure the score and this will provide 0-100 levels of hemoptysis and the score increases with increasing severity.
7 secondary outcomes
Adverse drug events
Time frame: 48 hours
Resolution of hemoptysis
Time frame: 48 Hours
Need for intervention
Time frame: 48 Hours
Need for blood transfusion
Time frame: 48 Hours
Duration of hospital stay
Time frame: 4 weeks
Mortality
Time frame: 4 weeks
Recurrence of hemoptysis
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 41221568Agrawal A, Dhibar DP, Prakash A, Sreedhara BC, Muthu V, Pannu AK. Efficacy and safety of tranexamic acid nebulization to control bleeding of hemoptysis: The TXA-NEB randomized controlled clinical trial. Indian J Pharmacol. 2025 Nov 1;57(6):392-400. doi: 10.4103/ijp.ijp_824_25. Epub 2025 Oct 12.
- Individual participant dataSharing planned: No
Related trials for Hemoptysis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TXA Nebulization and 0.9% NS Nebulization in people with Hemoptysis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deba P Dhibar, MD (9530881462, drdeba_prasad@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hemoptysis (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648656, which also lists 1 linked publication.
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 13 Dec 2022.