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    Summary
    EudraCT Number:2012-000343-26
    Sponsor's Protocol Code Number:ULTRA12
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-14
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000343-26
    A.3Full title of the trial
    Ultra-early tranexamic acid after subarachnoid hemorrhage.
    A prospective, randomized, multicenter study.
    Ultra-vroege toediening van tranexaminezuur na een subarachnoïdale bloeding.
    Een prospectieve, gerandomiseerde multicenter studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ultra-early tranexamic acid after subarachnoid hemorrhage.
    Ultra-vroege toediening van tranexaminezuur na een subarachnoïdale bloeding.
    A.3.2Name or abbreviated title of the trial where available
    ULTRA
    ULTRA
    A.4.1Sponsor's protocol code numberULTRA12
    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 SponsorAcademic Medical Center, Neurosurgery
    B.1.3.4CountryNetherlands
    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 supportAcademic Medical Center Amsterdam
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportFonds NutsOhra
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center Amsterdam
    B.5.2Functional name of contact pointULTRA contact point
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205666564
    B.5.6E-mailD.Verbaan@amc.uva.nl
    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 Cyklokapron
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCyklokapron
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    subarachnoid hemorrhage
    subarachnoïdale bloeding
    E.1.1.1Medical condition in easily understood language
    bleeding from a weak spot in a cerebral artery
    bloeding uit een zwakke plek in een hersenarterie
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether a group of patients with subarachnoid hemorrhage (SAH) treated by standard, state-of-the-art SAH management with additional ultra-early and short-term tranexamic acid (TXA) administration (TXA group) has a significantly higher percentage of patients with a favourable outcome after six months (score 0-3 on the Modified Rankin Scale) compared to a group treated by standard, state-of-the-art SAH management without additional TXA administration (control group).
    Om te evalueren of een groep van patiënten met een subarachnoïdale bloeding (SAB) die behandeld worden door middel van een standaard, up-to-date protocol met toevoeging van ultra-vroege en kortdurende toediening van tranexaminezuur (TXA) (TXA groep) een significant hoger percentage van patiënten met een gunstige uitkomst na zes maanden (score 0-3 op de Modified Rankin Scale) heeft, vergeleken met een groep van patiënten met een SAB die behandeld worden door middel van een standaard, up-to-date protocol zonder toevoeging van TXA (controlegroep).
    E.2.2Secondary objectives of the trial
    To evaluate significant differences between the TXA group and the control group in:
    • case fatality rate at discharge and 6 months after SAH
    • rebleed rate before or during treatment
    • thromboembolic complications during endovascular treatment
    • delayed cerebral ischemia rate
    • complications, such as hydrocephalus, extracranial thrombosis or hemorrhagic complications, during admission and at 6 months after SAH
    • (micro)infarctions on MR imaging at 6 months after endovascular treatment
    • care costs 6 months after SAH
    • quality of life 6 months after SAH

    • To evaluate whether there is a significant association between favourable outcome at six months after SAH and time between ictus and TXA administration
    • To evaluate whether there is a significant difference in rebleeds and favourable outcome between females and males and between patients in different WFNS groups at admittance
    • To evaluate the cause of poor outcome
    Om te evalueren of er significante verschillen zijn tussen de TXA groep en de controle groep in:
    • mortaliteit bij ontslag en 6 maanden na de SAB
    • aantal rebleeds voor of tijdens behandeling
    • tromboembolische complicaties tijdens endovasculaire behandeling
    • aantal gevallen van late cerebrale ischemie
    • complicaties, zoals hydrocefalus, extracraniële trombose of hemorragische complicaties, tijdens opname en 6 maanden na de SAB
    • (micro)infarcten op MRI 6 maanden na endovasculaire behandeling
    • zorgkosten 6 maanden na SAB
    • kwaliteit van leven 6 maanden na SAB

    • Om te evalueren of er een significante associatie is tussen een gunstige uitkomst 6 maanden na de SAB en de tijd tussen de ictus en TXA toediening
    • Om te evalueren of er een significant verschil is in rebleeds en gunstige uitkomst tussen vrouwen en mannen en tussen patiënten met een verschillende WFNS gradering bij binnenkomst
    • Om de oorzaak van een slechte uitkomst te evalueren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Admission to one of the study centers or their referring hospitals
    • CT-confirmed SAH with most recent ictus less than 24 hours ago
    • Age 18 years and older

    • Opname bij één van de studiecentra of diens verwijzende ziekenhuizen
    • Met CT bevestigde subarachnoïdale bloeding met de meest recente ictus minder dan 24 uur geleden
    • Leeftijd 18 jaar of ouder
    E.4Principal exclusion criteria
    • No proficiency of the Dutch or English language
    No loss of consciousness after the hemorrhage with World Federation of Neurological Surgeons (WFNS) grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage
    • Bleeding pattern on CT compatible with a traumatic SAH
    • Treatment for deep vein thrombosis
    • History of blood coagulation disorder
    • Pregnancy
    • Severe renal (serum creatinin >150 mmol/L) or liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or γ-GT > 150 U/l)
    • Imminent death within 24 hours
    • No proficiency of the Dutch or English language
    Geen bewustzijnsverlies na de bloeding met een World Federation of Neurological Surgeons (WFNS) graad 1 of 2 bij opname in combinatie met een perimesencephale bloeding
    • Bloedingspatroon op de CT scan passend bij een traumatische SAB
    • Behandeling voor diep veneuze trombose
    • Bloedstollingsproblemen in de voorgeschiedenis
    • Zwangerschap
    • Ernstig nier- (serum creatinine >150 mmol/L) of leverfalen (AST > 150 U/l of ALT > 150 U/l of AF > 150 U/l of γ-GT > 150 U/l)
    • Dreigend overlijden binnen 24 uur
    E.5 End points
    E.5.1Primary end point(s)
    Clinical outcome assessed by the Modified Rankin Scale Score dichotomized as a favourable (0-3) or unfavourable (4-6) outcome.
    Klinische uitkomst beoordeeld met de Modified Rankin Scale Score gedichotomiseerd als een gunstige (0-3) of ongunstige (4-6) uitkomst.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after SAH
    6 maanden na de SAB
    E.5.2Secondary end point(s)
    1: case fatality rate
    2: rebleed rate
    3: thromboembolic complications
    4: delayed cerebral ischemia rate
    5: complications (hydrocephalus, extracranial thrombosis or hemorrhagic complications)
    6: (micro)infarctions on MR imaging
    7: care costs
    8: quality of life

    1: mortaliteit
    2: aantal rebleeds
    3: tromboembolische complicaties
    4: aantal gevallen van late cerebrale ischemie
    5: complicaties (hydrocefalus, extracraniële trombose of hemorragische complicaties)
    6: (micro)infarcten op MRI
    7: zorgkosten
    8: kwaliteit van leven


    E.5.2.1Timepoint(s) of evaluation of this end point
    1: six months after SAH
    2: before or during aneurysm treatment
    3: during endovascular treatment
    4: during admission
    5: during admission and at six months after SAH
    6: six months after endovascular treatment
    7: six months after SAH
    8: six months after SAH
    1: 6 maanden na de SAB
    2: voor of tijdens behandeling van het aneurysma
    3: tijdens endovasculaire behandeling
    4: tijdens opname
    5: tijdens opname en 6 maanden na de SAB
    6: 6 maanden na endovasculaire behandeling
    7: 6 maanden na SAB
    8: 6 maanden na SAB
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    geblindeerde eindpunt meting
    blinded endpoint assessment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standaard, up-to-date behandeling (die de TXA groep ook krijgt)
    standard, up-to-date management (which is also received by the TXA group)
    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 concerned30
    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 Yes
    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
    Last endpoint assessment of last subject
    Laatste eindpuntmeting van laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 730
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the nature of the population studied, it is conceivable that in about 70% eligible subjects have a depressed level of consciousness at admittance and thus not be able to give informed consent.
    Gebaseerd op de kenmerken van de te bestuderen populatie, is het de verwachting dat zo'n 70% van de proefpersonen die geschikt zijn voor deelname een verlaagd bewustzijnsniveau hebben bij opname en daarom niet in staat zijn informed consent te geven.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state950
    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)
    None.
    Geen.
    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 Decision2012-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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