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    Summary
    EudraCT Number:2021-000586-33
    Sponsor's Protocol Code Number:19-PP-15
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-07-23
    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 number2021-000586-33
    A.3Full title of the trial
    Effect of molar sodium lactate infusion on cerebral hemodynamic in patients with severe subarachnoid hemorrhage: a multicenter double-blind randomized controlled study
    Effet du remplissage par lactate de sodium molaire sur
    l’hémodynamique cérébrale chez des patients présentant une
    hémorragie sous arachnoïdienne anévrysmale grave.
    Etude randomisée multicentrique
    LASH Study (LActate and Sub- arachnoid Hemorrhage)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Sodium LActate infusion on cerebral hemodynamic in severe Subarachnoid Hemorrhage (LASH)
    Effet du remplissage par lactate de sodium molaire sur
    l’hémodynamique cérébrale chez des patients présentant une
    hémorragie sous arachnoïdienne anévrysmale grave.
    A.3.2Name or abbreviated title of the trial where available
    LASH study
    LASH study
    A.4.1Sponsor's protocol code number19-PP-15
    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 Nice
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointmonch
    B.5.3 Address:
    B.5.3.1Street Address4 av Reine VICTORIA
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone numberFranc492034702
    B.5.5Fax numberFranc492034011
    B.5.6E-maildrc-chupromoteur@chu-nice.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 sodium lactate
    D.2.1.1.2Name of the Marketing Authorisation holderAPHP- ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
    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 namesodium lactate
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 sodium chloride
    D.2.1.1.2Name of the Marketing Authorisation holderB Braun
    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 namesodium chloride
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subarachnoid hemorrhage caused by rupture of cerebral aneurysm
    hémorragie sous arachnoïdienne anévrysmale grave
    E.1.1.1Medical condition in easily understood language
    meningee haemorrhage
    hémorragie méningée
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10042320
    E.1.2Term Subarachnoid hemorrhage
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Measure of incidence of angiographic vasospasm measured on 15 cerebral arterial segments: basillar vertebro trunk, right and left internal carotid artery, A1, A2, right and left anterior cerebral, M1, M2 of right and left foranity and P1, P2 of the right and left posterior cerebral between J0 and J7. The impact comparison between the two groups will be made. This measurement is performed blindly by an independent radiologist who is not familiar with the treatments received by the patient.
    Mesure de l’incidence du vasospasme angiographique mesuré sur 15 segments artériels cérébraux: tronc vertébro basillaire, artère carotide interne terminale droite et gauche, segment A1, A2, de la cérébrale antérieure droite et gauche, M1, M2 de la sylvienne droite et gauche et P1, P2 de la cérébrale postérieure droite et gauche entre J0 et J7. La comparaison de l’incidence entre les 2 groupes sera réalisée. Cette mesure est réalisée en aveugle par un radiologue indépendant et ne connaissant pas les traitements reçus par le patient.
    E.2.2Secondary objectives of the trial
    Measure of variation in peak velocity and cerebral blood flow at J0 and J7
    Measuring the variation in average transit time (TTM), the infusion scanner on 6 brain regions between J0 and J7. The maximum variation of this parameter will be compared between the two groups.
    Measuring the incidence of clinical vasospasm in the first 14 days
    Measuring the number of angiographic dilation or Milrinone dilation procedures required in the first 14 days.
    Measuring the impact of the J7 recall
    3-month prognostic evaluation: Glasgow Outcome Scale (GOS), modified Rankin Scale (mRS), hospital stay in resuscitation and total, hospital and 3-month mortality
    Systemic hemodynamic J0 and J7
    Cerebral hemodynamics, episodes of HTIC (if PIC presents) J0/J7
    J0 and J7 entry/exit check..
    Blood, urinary and blood gas (GDS) ionogram at J0 and J7
    Mesure de la variation du pic de vélocité et du débit sanguin cérébral à J0 et J7
    Mesure de la variation du temps de transit moyen (TTM), au scanner de perfusion sur 6 régions du cerveau entre J0 et J7. La variation maximale de ce paramètre sera comparée entre les 2 groupes.
    Mesure de l’incidence du vasospasme clinique au cours des 14 premiers jours
    Mesure du nombre de procédures de dilatations angiographiques ou de traitement par Milrinone nécessaires au cours des 14 premiers jours.
    Mesure de l’incidence du resaignement à J7
    Evaluation pronostique à 3 mois : Glasgow Outcome Scale (GOS), modified Rankin Scale (mRS), durée d’hospitalisation en réanimation et totale, mortalité hospitalière et à 3 mois
    Hémodynamique systémique J0 et J7
    Hémodynamique cérébrale, épisodes d‘HTIC (si PIC présente) J0/J7
    Bilan entrée /sortie J0 et J7.
    Ionogramme sanguin, urinaire et gaz du sang (GDS) à J0 et J7
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -all patients with a severe SAH (defined by WFNS score ≥ 3, with a aneurysm treated by an arterial embolization;
    - informed consent of the close (in case of emergency) and of the patients (initially if possible or as soon as possible),
    -belong to a social security scheme
    -After a suitable medical examination
    -Tout patient de plus de 18 ans présentant une hémorragie méningée grave définie par un score WFNS≥3 pourra être inclus dans l’étude.
    - Traité par embolisation par voie endovasculaire ou chirurgicalement dans les 48h
    - Après recueil du consentement éclairé du patient, ou de ses proches s’il n’est pas interrogeable (coma).
    - Affiliation à un régime de sécurité sociale
    - Après examen médical préalable adapté
    E.4Principal exclusion criteria
    Traumatic SAH, admission after more than 48 hrs of hemorrhage, neurodegenerative pathology, pregnancy, age < 18 yrs, refusal for participation
    Hémorragie méningée post-traumatique
    - Délai de prise en charge >48h par rapport au saignement
    - Pathologie neurodégénérative connue (Alzheimer, Parkinson …), maladie de Creutzfeld-Jacob
    - Femme enceinte
    - Décision de non-traitement
    - Refus de participation à l’étude
    - Enfants mineurs
    - Patient majeur protégé par la loi
    - Personne privée de liberté administrative ou judiciaire
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of cerebral vasospasm assessed by cerebral CT-scan angiography and perfusion
    • Within the first 7 days following arterial embolization of the aneurysm
    • Lié à la sécurité : 0 OUI 1 NON

    Mesure de l’incidence du vasospasme angiographique mesuré sur 15 segments artériels cérébraux : tronc vertébro basilaire, artère carotide interne terminale droite et gauche, segment A1, A2, de la cérébrale antérieure droite et gauche, M1, M2 de la sylvienne droite et gauche et P1, P2 de la cérébrale postérieure droite et gauche entre J0 et J7. La variation maximale de ce paramètre sera comparée entre les 2 groupes. Cette mesure est réalisée en aveugle par un radiologue indépendant et ne connaissant pas les traitements reçus par le patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    between J0 and J7
    entre J7 et J0
    E.5.2Secondary end point(s)
    - Variation of the mean time of cerebral arterial transit on 6 regions of brain, cerebral blood flow and peak of velocity (CT scan with perfusion)
    - Number of cerebral arterial mechanical (arteriography) and/or pharmacological (milrinone) vasodilation needed within the first 14 days
    - Incidence of new hemorrhage episodes within the first 7 days
    - Neurological outcome at 3 months assessed by the Glasgow Outcome Scale (GOS) and the modified Rankin score (mRS)
    - Secondary Cerebral ischemia at 3 months
    - Systemic hemodynamic at day 0 and 7
    - Numbers of raised intracranial episodes within the first 7 days (in case of intracranial pressure monitoring)
    - - Plasma and urinary major electrolytes and arterial blood gases at day 0 and 7
    Mesure de la variation du temps de transit moyen (TTM), au scanner de perfusion sur 6 régions du cerveau entre J0 et J7 de la perfusion du produit. La variation maximale de ce paramètre sera comparée entre les 2 groupes. Cette mesure est réalisée en aveugle par un radiologue indépendant et ne connaissant pas les traitements reçus par le patient.
    • Mesure de la variation du pic de vélocité et du débit sanguin cérébral à J0 et J7
    • Mesure du vasospasme angiographique à J0 et J7
    • Mesure du nombre de procédures de dilatations angiographiques ou de traitement par Milrinone nécessaires au cours des 14 premiers jours.
    • Mesure de l’incidence du resaignement à J7
    • Evaluation pronostique à 3 mois : GOS, mRS, durée d’hospitalisation en réanimation et totale, mortalité hospitalière et à 3 mois
    • Mesure de l’ischémie cérébrale au TDM cérébral à 3 mois
    • Hémodynamique systémique J0 et J7
    • Hémodynamique cérébrale, épisodes d‘HTIC (si PIC présente) à J0 et J7
    • Bilan entrée /sortie J0 et J7.
    • Ionogramme sanguin, urinaire et GDS à J0 et J7
    E.5.2.1Timepoint(s) of evaluation of this end point
    between J0 and J7
    entre J7 et J0
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient that arrive in emergency department with severe Subarachnoid Hemorrhage
    Patient arrivant au service des urgences avec une hémorragie sous arachnoïdienne anévrysmale grave
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    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)
    the participation of the patient in the study ends after this visit, and their follow-up is resumed based on the guidelines for their condition.
    La participation du patient à l’étude se termine après la visite de fin d'étude, et leur suivi est repris sur la base des lignes directrices pour leur état.
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-06-07
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