Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:02 PM
Study NCT ID:
NCT04961528
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2021-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006469', 'term': 'Hemoptysis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077585', 'term': 'Terlipressin'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008236', 'term': 'Lypressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 315}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with complete or partial resolution of hemoptysis without the use of any interventional procedure.', 'timeFrame': '3 days', 'description': '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.\n\nA 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'}], 'secondaryOutcomes': [{'measure': 'Rate of complete resolution of hemoptysis within 3 days, as previously defined', 'timeFrame': '3 days', 'description': 'Complete resolution of hemoptysis, as previously defined'}, {'measure': 'Rate of partial resolution of hemoptysis defined as recurrence < 50 ml', 'timeFrame': '3 days', 'description': 'Partial resolution of hemoptysis, as previously defined'}, {'measure': 'Rate of patients with total volume of hemoptysis < 200 ml', 'timeFrame': '3 days', 'description': 'Total volume of hemoptysis \\< 200 ml'}, {'measure': 'Rate of patients who need an endovascular treatment (bronchial arterial endovascular embolization)', 'timeFrame': '3 days', 'description': 'Need of invasive procedure such as bronchial arterial endovascular embolization'}, {'measure': 'Time between hospital admission and bronchial arterial endovascular embolization', 'timeFrame': '3 days', 'description': 'Time between hospital admission and endovascular treatment'}, {'measure': 'Rate of patients who need a mechanical ventilation', 'timeFrame': '3 days', 'description': 'Need of invasive procedure such as mechanical ventilation,'}, {'measure': 'Rate of specific adverse events', 'timeFrame': '3 days', 'description': 'Specific Adverse Events (AE) : acute myocardial ischemia, symptomatic venous thromboembolism, hyponatremia (\\<130 mmol/L), bronchospasm (defined by the need of short-acting bronchodilatator).'}, {'measure': 'Rate of in-hospital mortality', 'timeFrame': '30 days'}, {'measure': 'Rate of patients with hemoptysis recurrence', 'timeFrame': '30 days'}, {'measure': 'Death rate', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['terlipressin', 'tranexamic acid'], 'conditions': ['Hemoptysis']}, 'descriptionModule': {'briefSummary': '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.\n\nThis randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.', 'detailedDescription': 'In over 90% of cases, hemoptysis is due to a bronchial or non-bronchial systemic arterial mechanism.\n\nEmbolization of Bronchial Arteries (EBA) is the main specific treatment but is not easily available. Medical treatment for hemoptysis is not evidence-based.\n\nFor 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.\n\nAcid 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.\n\nThe investigator hypothetize that inhaled antifibrinolytic (TXA) or vasoconstrictor (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.\n\nPatients will be randomized into 3 groups:\n\n* Active treatment 1: Tranexamic Acid 500 mg three times a day (every 8 hours) for 5 days.\n* Active treatment 2: Terlipressin 1 mg three times a day (every 8 hours) for 5 days.\n* Placebo: normal saline nebulization three times a day (every 8 hours) for 5 days.\n\nUsing 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years, under 90 years\n* Mild to severe hemoptysis that has been going on for less than 7 days\n* Total expectorate blood ranging from 50 ml to 200 ml\n* Admission in emergency department or ICU for less than 12 hours\n* Social security affiliation\n* Signed informed consent\n* For child-bearing aged women, efficient contraception includes oral oestrogen- progestin, oral progestin, progestin implants and all types of intrauterine devices\n\nExclusion Criteria:\n\n* Need for mechanical ventilation\n* Cystic fibrosis\n* Pregnancy or breast feeding\n* Contraindication for contrast agents injection (renal failure with creatinin clearance \\< 30mL/min, know allergy to contrast agents injection)\n* Known hypersensitivity to TXA or TER or one of its excipients\n* Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..)\n* Contraindication to TXA (including renal failure with creatinin clearance \\< 30mL/min) or TER therapy :\n\n * acute myocardial infarction in the 6 past months,\n * intrathecal injection in the 3 past months,\n * seizure in the past 3 months\n* Participation in another interventional study or being in the exclusion period at the end of a previous study.\n* Patient under tutorship or / guardianship, and incapable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04961528', 'acronym': 'ACTIVE', 'briefTitle': 'ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.', 'orgStudyIdInfo': {'id': 'APHP200043'}, 'secondaryIdInfos': [{'id': '2020-005931-58', 'type': 'EUDRACT_NUMBER'}, {'id': 'PHRC-19-0412', 'type': 'OTHER_GRANT', 'domain': 'French ministry of health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Terlipressin', 'description': "Dosage: 1 mg /5 ml Pharmaceutical form: solution for infusion Posology: 1 mg /8 hours Treatment duration: 3 days\n\nMethod and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers", 'interventionNames': ['Drug: Terlipressin']}, {'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid', 'description': "Dosage : 500 mg /5 ml Pharmaceutical form: solution for infusion Posology (and adjustments based on toxicity) : 500 mg/ 8 hours Treatment duration: 3 days\n\nMethod and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers.", 'interventionNames': ['Drug: Tranexamic Acid 500 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline Placebo', 'description': "Dose : normal saline solution (NaCl 0.9%) Pharmaceutical form : solution for infusion Posology : 5ml / 8 hours Treatment duration: 3 days\n\nMethod and route of administration: inhalation using the same jet nebulizers (INT'AIR Medical RN 300) in all Investigating centers.", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tranexamic Acid 500 MG', 'type': 'DRUG', 'description': '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).\n\nThe nebulization lasts 10 minutes. Posology: 500 mg x 3/day (= 500 mg / 8 hours) Treatments duration: 3 days', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'Terlipressin', 'type': 'DRUG', 'description': '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).\n\nThe nebulization lasts 10 minutes. Posology: 1 mg x 3/day (= 1 mg / 8 hours) Treatments duration: 3 days', 'armGroupLabels': ['Terlipressin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline placebo'], 'description': '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).\n\nThe nebulization lasts 10 minutes. Posology: 5ml x 3/day (= 5 ml / 8 hours) Treatments duration: 3 days.', 'armGroupLabels': ['Normal Saline Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Planquette, MD', 'role': 'CONTACT', 'email': 'benjamin.planquette@aphp.fr'}], 'facility': 'AP-HP, Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Karine Goude-Ory', 'role': 'CONTACT', 'email': 'karine.goude@aphp.fr', 'phone': '01 44 84 17 22'}, {'name': 'Cléo Bourgeois', 'role': 'CONTACT', 'email': 'cleo.bourgeois@aphp.fr', 'phone': '01 56 09 56 38'}], 'overallOfficials': [{'name': 'Benjamin Planquette, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'AP-HP, Hôpital Européen Georges Pompidou, Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.\n\nTeams wishing obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasability and financial support will be discussed before mandatory contractual agreement.\n\nProcessing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}