HemoptysisPhase 3ACTIVENCT04961528
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
A Phase 3 study testing Tranexamic Acid 500 MG and Terlipressin in people with Hemoptysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study aims is to verify the hypothetize that inhaled Tranexamic Acid (TXA) or Terlipressin (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemoptysis
- What is being tested?
- Tranexamic Acid 500 MG and Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2022to 25 Mar 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years, under 90 years
- Mild to severe hemoptysis that has been going on for less than 7 days
- Total expectorate blood ranging from 50 ml to 200 ml
- Admission in emergency department or ICU for less than 12 hours
- Social security affiliation
- Signed informed consent
- For child-bearing aged women, efficient contraception includes oral oestrogen- progestin, oral progestin, progestin implants and all types of intrauterine devices
Who cannot join
- Need for mechanical ventilation
- Cystic fibrosis
- Pregnancy or breast feeding
- Contraindication for contrast agents injection (renal failure with creatinin clearance < 30mL/min, know allergy to contrast agents injection)
- Known hypersensitivity to TXA or TER or one of its excipients
- Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..)
Show all 12Show fewer
- Contraindication to TXA (including renal failure with creatinin clearance < 30mL/min) or TER therapy :
- acute myocardial infarction in the 6 past months,
- intrathecal injection in the 3 past months,
- seizure in the past 3 months
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
- Patient under tutorship or / guardianship, and incapable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The study aims is to verify the hypothetize that inhaled Tranexamic Acid (TXA) or Terlipressin (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.
This randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.
Read the detailed description
In over 90% of cases, hemoptysis is due to a bronchial or non-bronchial systemic arterial mechanism.
Embolization of Bronchial Arteries (EBA) is the main specific treatment but is not easily available. Medical treatment for hemoptysis is not evidence-based.
For this study, the investigators will dispense trial drugs using inhalation route which has not been evaluated in mild to severe hemoptysis in previous trials. In addition, as opposed to previous trials, the investigators will assess the safety of trials drugs during hospital stay.
Acid tranexamic (TXA), an antifibrinolytic drug, reduces bleeding in uterine and traumatic haemorrhage by blocking the action of plasmin on fibrin. Intravenous terlipressin (TER), a vasoconstrictor, contributes to control digestive haemorrhage but presents many contraindication when administrated by intravenous route.
The investigator hypothetize that inhaled antifibrinolytic (TXA) or vasoconstrictor (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.
Patients will be randomized into 3 groups:
- Active treatment 1: Tranexamic Acid 500 mg three times a day (every 8 hours) for 3 days.
- Active treatment 2: Terlipressin 1 mg three times a day (every 8 hours) for 3 days.
- Placebo: normal saline nebulization three times a day (every 8 hours) for 3 days.
Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER vs placebo is demonstrated. The above secondary objectives will then be assessed for the comparison of TXA versus TER.
- Conditions
- Hemoptysis
- Being tested
- Tranexamic Acid 500 MG, Terlipressin, Placebo
- Keywords
- terlipressin, tranexamic acid
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 500 MGDrug
Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient).
The nebulization lasts 10 minutes. Posology: 500 mg x 3/day (= 500 mg / 8 hours) Treatments duration: 3 days
TerlipressinDrug
Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient).
The nebulization lasts 10 minutes. Posology: 1 mg x 3/day (= 1 mg / 8 hours) Treatments duration: 3 days
PlaceboDrug
Also called Normal saline placebo
Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient).
The nebulization lasts 10 minutes. Posology: 5ml x 3/day (= 5 ml / 8 hours) Treatments duration: 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Experimental | Dosage: 1 mg /5 ml Pharmaceutical form: solution for infusion Posology: 1 mg /8 hours Treatment duration: 3 days
Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers Receives: Drug: Terlipressin |
| Tranexamic Acid | Experimental | Dosage : 500 mg /5 ml Pharmaceutical form: solution for infusion Posology (and adjustments based on toxicity) : 500 mg/ 8 hours Treatment duration: 3 days
Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers. Receives: Drug: Tranexamic Acid 500 MG |
| Normal Saline Placebo | Placebo comparator | Dose : normal saline solution (NaCl 0.9%) Pharmaceutical form : solution for infusion Posology : 5ml / 8 hours Treatment duration: 3 days
Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure.
Efficacy of inhaled tranexamic acid and inhaled terlipressin versus placebo (normal saline) in immediate control of mild to severe hemoptysis within the first 3 days of hospitalization.
A complete resolution of hemoptysis is defined by absence of recurrence within 3 days; partial resolution is defined as hemoptysis recurrence < 50 ml within the first 3 days
Measured: 3 days
Secondary outcomes (10)
Rate of complete resolution of hemoptysis within 3 days, as previously defined
Complete resolution of hemoptysis, as previously defined
Measured: 3 days
Rate of partial resolution of hemoptysis defined as recurrence < 50 ml
Partial resolution of hemoptysis, as previously defined
Measured: 3 days
Rate of patients with total volume of hemoptysis < 200 ml
Total volume of hemoptysis < 200 ml
Measured: 3 days
Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)
Need of invasive procedure such as bronchial arterial endovascular embolization
Measured: 3 days
Time between hospital admission and bronchial arterial endovascular embolization
Time between hospital admission and endovascular treatment
Measured: 3 days
Rate of patients who need a mechanical ventilation
Need of invasive procedure such as mechanical ventilation,
Measured: 3 days
Rate of specific adverse events
Specific Adverse Events (AE) : acute myocardial ischemia, symptomatic venous thromboembolism, hyponatremia (<130 mmol/L), bronchospasm (defined by the need of short-acting bronchodilatator).
Measured: 3 days
Rate of in-hospital mortality
Measured: 30 days
Rate of patients with hemoptysis recurrence
Measured: 30 days
Death rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start27 Mar 2022
- Primary completion28 Dec 2025
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Benjamin Planquette, MD, PhD, Study chair, AP-HP, Hôpital Européen Georges Pompidou, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961528
- Sponsor's protocol ID
- APHP200043
- Other IDs
- 2020-005931-58, PHRC-19-0412
- Acronym
- ACTIVE
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
- ClinicalTrials.gov ID
- NCT04961528
- Acronym / sponsor ID
- ACTIVE / APHP200043
- Conditions
- Hemoptysis
- Keywords
- terlipressin, tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 14 Jul 2021 (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.
The study aims is to verify the hypothetize that inhaled Tranexamic Acid (TXA) or Terlipressin (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.
This randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.
Detailed description
In over 90% of cases, hemoptysis is due to a bronchial or non-bronchial systemic arterial mechanism.
Embolization of Bronchial Arteries (EBA) is the main specific treatment but is not easily available. Medical treatment for hemoptysis is not evidence-based.
For this study, the investigators will dispense trial drugs using inhalation route which has not been evaluated in mild to severe hemoptysis in previous trials. In addition, as opposed to previous trials, the investigators will assess the safety of trials drugs during hospital stay.
Acid tranexamic (TXA), an antifibrinolytic drug, reduces bleeding in uterine and traumatic haemorrhage by blocking the action of plasmin on fibrin. Intravenous terlipressin (TER), a vasoconstrictor, contributes to control digestive haemorrhage but presents many contraindication when administrated by intravenous route.
The investigator hypothetize that inhaled antifibrinolytic (TXA) or vasoconstrictor (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.
Patients will be randomized into 3 groups:
- Active treatment 1: Tranexamic Acid 500 mg three times a day (every 8 hours) for 3 days.
- Active treatment 2: Terlipressin 1 mg three times a day (every 8 hours) for 3 days.
- Placebo: normal saline nebulization three times a day (every 8 hours) for 3 days.
Using a hierarchical analysis, the comparison between TXA and TER will be tested once superiority on efficacy of both inhaled TXA and TER vs placebo is demonstrated. The above secondary objectives will then be assessed for the comparison of TXA versus TER.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Experimental | Drug: TerlipressinDosage: 1 mg /5 ml Pharmaceutical form: solution for infusion Posology: 1 mg /8 hours Treatment duration: 3 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers |
| Tranexamic Acid | Experimental | Drug: Tranexamic Acid 500 MGDosage : 500 mg /5 ml Pharmaceutical form: solution for infusion Posology (and adjustments based on toxicity) : 500 mg/ 8 hours Treatment duration: 3 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers. |
| Normal Saline Placebo | Placebo comparator | Drug: PlaceboDose : normal saline solution (NaCl 0.9%) Pharmaceutical form : solution for infusion Posology : 5ml / 8 hours Treatment duration: 3 days Method and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years, under 90 years
- Mild to severe hemoptysis that has been going on for less than 7 days
- Total expectorate blood ranging from 50 ml to 200 ml
- Admission in emergency department or ICU for less than 12 hours
- Social security affiliation
Key exclusion criteria (12 listed)
- Need for mechanical ventilation
- Cystic fibrosis
- Pregnancy or breast feeding
- Contraindication for contrast agents injection (renal failure with creatinin clearance < 30mL/min, know allergy to contrast agents injection)
- Known hypersensitivity to TXA or TER or one of its excipients
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 500 MGJet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient). The nebulization lasts 10 minutes. Posology: 500 mg x 3/day (= 500 mg / 8 hours) Treatments duration: 3 days | Drug | Tranexamic Acid |
| TerlipressinJet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient). The nebulization lasts 10 minutes. Posology: 1 mg x 3/day (= 1 mg / 8 hours) Treatments duration: 3 days | Drug | Terlipressin |
| PlaceboAlso: Normal saline placeboJet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient). The nebulization lasts 10 minutes. Posology: 5ml x 3/day (= 5 ml / 8 hours) Treatments duration: 3 days. | Drug | Normal Saline Placebo |
Primary outcome
Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure.
Time frame: 3 days
Efficacy of inhaled tranexamic acid and inhaled terlipressin versus placebo (normal saline) in immediate control of mild to severe hemoptysis within the first 3 days of hospitalization. A complete resolution of hemoptysis is defined by absence of recurrence within 3 days; partial resolution is defined as hemoptysis recurrence < 50 ml within the first 3 days
10 secondary outcomes
Rate of complete resolution of hemoptysis within 3 days, as previously defined
Time frame: 3 days
Rate of partial resolution of hemoptysis defined as recurrence < 50 ml
Time frame: 3 days
Rate of patients with total volume of hemoptysis < 200 ml
Time frame: 3 days
Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)
Time frame: 3 days
Time between hospital admission and bronchial arterial endovascular embolization
Time frame: 3 days
Rate of patients who need a mechanical ventilation
Time frame: 3 days
Rate of specific adverse events
Time frame: 3 days
Rate of in-hospital mortality
Time frame: 30 days
Rate of patients with hemoptysis recurrence
Time frame: 30 days
Death rate
Time frame: 30 days
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 23 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Benjamin Planquette, MD, PhD study chair
AP-HP, Hôpital Européen Georges Pompidou, Paris
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 Tranexamic Acid 500 MG and Terlipressin in people with Hemoptysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 12 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 23 Apr 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 France. 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?
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?
Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure. (time frame: 3 days). 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 23 Apr 2026.