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    Summary
    EudraCT Number:2014-003338-15
    Sponsor's Protocol Code Number:RBHP2014ELJEZI
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2014-003338-15
    A.3Full title of the trial
    Role of Nitric Oxide (NO) in pre-oxygenation before anesthetic induction in patients with Pulmonary Hypertension (PH) in cardiac surgery.
    Feasibility study.
    Rôle du Monoxyde d'Azote (NO) en pré-oxygénation avant induction anesthésique chez les patients porteurs d'une Hypertension Pulmonaire (HTP) en chirurgie cardiaque.
    Etude de faisabilité.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of inhaled Nitric Oxide (NO) before cardiac surgery in patients with Pulmonary Hypertension
    Rôle du monoxyde d'azote inhalé avant une chirurgie cardiaque chez les patients porteurs d'une Hypertension Pulmonaire
    A.3.2Name or abbreviated title of the trial where available
    NOCaPH
    A.4.1Sponsor's protocol code numberRBHP2014ELJEZI
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Clermont-Ferrand
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAssociation ARAMU (anesthésie réanimation analgésie médecine d' urgence)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointPatrick LACARIN
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473751195
    B.5.5Fax number0033473754730
    B.5.6E-mailplacarin@chu-clermont-ferrand.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kinox 450 ppm mole/mole
    D.2.1.1.2Name of the Marketing Authorisation holderAir Liquid Santé International
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemonoxyde d'azote
    D.3.4Pharmaceutical form Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNITRIC OXIDE
    D.3.9.2Current sponsor codemonoxyde d'azote
    D.3.9.4EV Substance CodeSUB12540MIG
    D.3.10 Strength
    D.3.10.1Concentration unit l litre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Cardiac surgery open heart
    - Pulmonary Hypertension with PAPs> 40 mmHg secondary to left heart disease or COPD (class 2 or 3), diagnosed by preoperative right heart catheterization or transthoracic echocardiography.
    - Chirurgie cardiaque à cœur ouvert
    - HTP avec PAPs > 40 mmHg secondaire à une cardiopathie gauche ou à une BPCO (classe 2 ou 3), diagnostiquée par cathétérisme cardiaque droit préopératoire ou par échocardiographie trans-thoracique.
    E.1.1.1Medical condition in easily understood language
    - Cardiac surgery open heart
    - Pulmonary Hypertension
    - Chirurgie cardiaque à cœur ouvert
    - Hypertension Artérielle Pulmonaire
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017501
    E.1.2Term Functional disturbances following cardiac surgery
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the feasibility and safety of routine administration of nitric oxide before anesthetic induction of the holders of moderate to severe pulmonary hypertension before having heart surgery with cardiopulmonary bypass. The effect will be evaluated in terms of efficiency (hemodynamic and respiratory optimizing).
    Evaluer la faisabilité et la tolérance de l’administration systématique de monoxyde d'azote avant induction anesthésique des patients porteurs d'une hypertension pulmonaire modérée à sévère devant avoir une chirurgie cardiaque sous circulation extracorporelle. L’effet sera jugé en termes d’efficacité (optimisation hémodynamique et respiratoire).
    E.2.2Secondary objectives of the trial
    - Study the different types of hemodynamic and respiratory behaviors under treatment.
    - Estimate the direct costs of the technique.
    - Etudier les différents types de comportements hémodynamiques et respiratoires sous traitement.
    - Estimer les coûts directs de la technique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 18 years
    - No exclusion criteria
    - Cardiac surgery open heart
    - Pulmonary Hypertension with PAPs> 40 mmHg secondary to left heart disease or COPD (class 2 or 3), diagnosed by preoperative right heart catheterization or transthoracic echocardiography.
    - Having given their written consent
    - Affiliated to Social Security
    - Age > 18 ans
    - Absence de critères de non inclusion
    - Chirurgie cardiaque à cœur ouvert
    - HTP avec PAPs > 40 mmHg secondaire à une cardiopathie gauche ou à une BPCO (classe 2 ou 3), diagnostiquée par cathétérisme cardiaque droit préopératoire ou par échocardiographie trans-thoracique.
    - Ayant donné leur consentement écrit
    - Affiliés à un régime de Sécurité Sociale
    E.4Principal exclusion criteria
    - Heart Transplantation
    - Pulmonary Hypertension type 1, 4, 5 as classified by Dana Point 2008
    - Deficit in methemoglobin reductase.
    - Refusal to protocol.
    - Transplantation cardiaque
    - HTP de type 1, 4, 5 selon la classification de Dana Point-2008
    - Déficit en méthémoglobine réductase.
    - Refus de protocole.
    E.5 End points
    E.5.1Primary end point(s)
    • Absolute values ​​of PAPs PAPm, PAPD, RVP, IC, DC, RVS and SVO2,
    • Ratio PAPm / PAm,
    • Ratio [(PAPm / PAm post induction) - (PAPm / PAm pre induction)] / (PAPm / PAm pre induction)
    • SaO2 and PaO2,
    • SpO2,
    • FeO2,
    • MetHb
    • Valeurs absolues des PAPs, PAPm, PAPd, RVP, IC, DC, RVS, et SVO2,
    • Ratio PAPm/PAm,
    • Ratio : [(PAPm/PAm post induction)- (PAPm/PAm pré induction)] / (PAPm/PAm pré induction),
    • SaO2 et PaO2,
    • SpO2,
    • FeO2,
    • MetHb
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Absolute values ​​of PAPs, PAPm, PAPd, RVP, IC, DC, RVS, SVO2 and FeO2, :
    - In ambiant air,
    - During oxygenation: each minute for 10 mn,
    - While inhaling oxygen + nitrogen monoxide: each minute for 10 mn,
    - at induction,
    - 2 mn after the start of Assisted Ventilation Controlled,
    - 5 mn after the start of the Assisted Controlled Ventilation.
    • Ratio PAPm / PAm,
    • Ratio [(PAPm / PAm post induction) - (PAPm / PAm pre induction)] / (PAPm / PAm pre induction)
    • SaO2, PaO2, SpO2, MetHb: each of these values ​​will be raised:
    - On arrival (t0)
    - at the 10th mn (end of pre-oxygenation)
    - at the 20th mn (end of inhalation O2 + NO)
    - At the end of induction of anesthesia after the positioning of the endotracheal tube checked,
    - After 5 mn of ventilation with pure oxygen.
    • Valeurs absolues des PAPs, PAPm, PAPd, RVP, IC, DC, RVS, SVO2 and FeO2 :
    - en air ambiant,
    - pendant l'oxygénation : toutes les mn pendant 10 mn,
    - pendant l'inhalation O2 + NO : toutes les mn pendant 10 mn,
    - à l'induction,
    - 2 mn après le début de la VAC (Ventilation Assistée Contrôlée),
    - 5 mn après le début de la VAC.
    • Ratio PAPm/PAm,
    • Ratio : [(PAPm/PAm post induction)- (PAPm/PAm pré induction)] / (PAPm/PAm pré induction),
    • SaO2, PaO2, SpO2, MetHb :
    - à l'arrivée (temps t0),
    - à la 10ème mn (fin de la pré-oxygénation),
    - à la 20ème mn (fin de l'inhalation O2 + NO),
    - à la fin de l'induction anesthésique une fois le positionnement de la sonde d'intubation vérifié,
    - après 5 mn de ventilation en oxygène pur.
    E.5.2Secondary end point(s)
    Absolute values ​​of PAs, PAm, PAd
    Valeurs absolues des PAs, PAm, PAd.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Absolute values ​​of PAs, PAm, PAd : each of these values ​​will be raised:
    - In ambiant air,
    - During oxygenation: each minute for 10 minutes,
    - While inhaling oxygen + nitrogen monoxide : each minute for 10 minutes,
    - at Induction,
    - 2 minutes after the start of Assisted Controlled Ventilation,
    - 5 minutes after the start of the Assisted Controlled Ventilation.
    • Valeurs absolues des PAs, PAm, PAd : chacune de ces valeurs sera relevée :
    - en air ambiant,
    - pendant l'oxygénation : toutes les minutes pendant 10 minutes,
    - pendant l'inhalation oxygène + monoxyde d'azote : toutes les minutes pendant 10 minutes,
    - à l'induction,
    - 2 minutes après le début de la Ventilation Assistée Contrôlée,
    - 5 minutes après le début de la Ventilation Assistée Contrôlée.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLP
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No different than the usual care patients
    Non différent de la prise en charge habituelle des patients
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
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