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    Summary
    EudraCT Number:2008-005653-37
    Sponsor's Protocol Code Number:ICH-VKA
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-005653-37
    A.3Full title of the trial
    Multicenter, prospective randomized trial on the use of prothrombin complex and fresh frozen plasma in patients with intracerebral hemorrhage related to vitamin K antagonists (VKA)
    Multicenter, prospektiv randomiseret sammenligning af prothrombin complex og frisk frossen plasma ved Vitamin-K antagonist relateret intracerebral hæmorragi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acute treatment of stroke in patients reciving anticoagulant treatment
    Akut behandling af hjerneblødning ved blodfortyndende behandling
    A.3.2Name or abbreviated title of the trial where available
    ICH-VKA
    ICH-VKA
    A.4.1Sponsor's protocol code numberICH-VKA
    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 SponsorUniversityhospital of Heidelberg
    B.1.3.4CountryGermany
    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 supportOctapharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Heidelberg
    B.5.2Functional name of contact pointCoordination Center for Clinical Tr
    B.5.3 Address:
    B.5.3.1Street AddressVossstrase/Gebäude 4410
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69115
    B.5.3.4CountryGermany
    B.5.4Telephone number+49062215634513
    B.5.5Fax number+49062215633508
    B.5.6E-mailanja.freiberger@kks-hd.de
    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 Octaplex
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma AD, Sweden
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Powder and solvent for suspension 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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Fresh frozen plasma - no trade name
    D.2.1.1.2Name of the Marketing Authorisation holderDifferent blood banks in Denmark
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameFresh frozen plasma
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman plasma coagulation factors
    D.3.9.2Current sponsor codeFresh frozen plasma
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 ml/ kg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Intracerebral hemorrhage (ICH) in patients related to vitamin K antagonists
    Multicenter, prospektiv randomiseret sammenligning af prothrombin complex og frisk frossen plasma ved Vitamin-K antagonist relateret intracerebral hæmorragi.
    E.1.1.1Medical condition in easily understood language
    Acute treatment of stroke related to anticoagulant treatment.
    Akut behandling af hjerneblødning ved blodfortyndende behandling.
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10022754
    E.1.2Term Intracerebral 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
    Efficacy of PCC compared to FPP in patients with ICH-VKA
    Sammenligning af effekt af PCC og FFP hos patienter med VKA-ICH
    E.2.2Secondary objectives of the trial
    Safety and efficacy of PCC compared to FPP in patients with ICH-VKA
    Sikkerhed og effekt af PCC sammelignet med FFP hos patienter med VKA-ICH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Spontaneous ICH (intraparenchymal), subdural hematoma (SDH) diagnosed by CT scanning ≤ 12 hours after onset of symptoms. In case of unknown time of symptom onset: time between last seen in healthy condition and first CCT ≤ 12 hours.
    2. Therapy receiving vitamin K antagonists (VKA)
    3. International Normalized Ratio (INR) ≥ 2
    4. Male or female subjects, age ≥ 18 years

    Spontan TCH, SDH diagnosticeret ved CT indenfor 12 timer efter symptomdebut, hvis ukendt defineret som sidst set rask indenfor 12 timer inden CTC
    2. I behandling med VKA
    3. INR >=2
    4.mindst 18 år gammel
    E.4Principal exclusion criteria
    1 Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
    2. Deep Coma (GCS ≤ 5) at the time of admission or before intubation if intubated outside the hospital
    3. Known thrombocytopenia (platelets <50,000/L), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)
    4. Pregnancy and lactation
    5. Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke
    6. Acute or known congestive heart failure (NYHA III, IV)
    7. Pulmonary edema
    8. Known history of claudicatio intermittens
    9. Known recent thrombotic event < 30 days
    10. Known active malignant disease
    11. Known alcohol or other drug abuse
    12. Known previous disability (mRS > 2 before stroke occurred)
    13. Known liver failure (child-pugh-score C)
    14. History of hypersensitivity to the investigational products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
    15. Known allergy to heparin or history of heparin induced thrombocytopenia.
    16. Previous participation in this trial
    17. Participation in ANY clinical trial within 30 days of entry into the trial and during the trial
    19. Concomitant use of antithrombotic (with PTT > 1.5 of normal PTT), thrombolytic treatment. – Use of aspirin, clopidogrel or dipyridamole or combinations thereof (e.g. Aggrenox®) is not an exclusion criterion. These drugs should be discontinued and not restarted earlier than 24 hours after normalization of INR if indicated.
    Sekundær ICH (infarkt, hæmofili, tumor,sinusthrombose,aneurisme, AVM eller signifikant hovedtraume)
    2.Dyb coma defineret som GCS<=5 ved indlæggelse elle før intubation præ-hospitalt
    3. Kendt koagulationsforstyrrelse
    graviditet eller laktation
    4. akut myokardieinfarkt, sepsis, vævsknusning eller tidligere dessimineret intravskulær koagulation.
    6. Kendt hjertesvigt (NYHA III,IV)
    7. Lungeødem
    8. kendt Claudicatio
    9.Kendt thrombose < 30 dage
    10. Kendt aktiv malign sygdom.
    11. Kendt alkohol eller stofmisbrug.
    12. Kendt eksisterende handikap (mRS >2)
    13. Kendt leversvigt
    14. Kendt overfølsomhed overfor Octaplex eller hepariner.
    15. tidligere deltagelse i denne trial eller deltagelse i anden interventionel trial indenfor 30 dage
    16. absolut indikation for fortsat brug af plade-hæmmer under studiebehandlingen.

    Aku
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients with INR ≤ 1.2 3 hours after start of drug infusion
    Antal patienter med INR<= 1,2 3 timer efter start af studiemedicin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 hours after initiation of study drug
    3 timer efter start af studie medicin
    E.5.2Secondary end point(s)
    1. Time to normalisation of INR (measured 30 min and 3 hours after start of infusion, or at the end of infusion if FFP is terminated before 3 hours)
    2. Hematomagrowth defined as change in hematoma volume within 24 hours.
    3. Modified rankin Scale, at day 15 and 90.
    4. National Institute of health Stroke Scale at 15 days.
    5. Glasgow outcome scale at day 90.
    6. Barthel Index at day 90.
    EQ-5D self-report questionnaire (Quality of life at day 90.
    1. Tid til normalisering af INR (målt efter 30 min og 3 timer efter start af infusion, hvis FFP ved afslutning af infusion, hvis før 3 timer)
    2. Hæmatomvækst defineret ved forskel i hæmatom volumen indenfor 24 timer.
    3. Modified rankin Scale, pådag 15 og 90.
    4. National Institute of health Stroke Scale på dag 15.
    5. Glasgow outcome scale på dag 90.
    6. Barthel Index på dag 90.
    EQ-5D self-report questionnaire (Livskvalitet) på dag 90.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The above mentioned end points are evaluated at 15 days or 90 days as described under the individual items above
    Evalueres efter 15 dage eller 90 dage som anført under de enkelte punkter
    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 Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    blindet observatør
    observer-blinded
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 Information not present in EudraCT
    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
    The trial ends after 74 subjects have been included and the last patient has finished the last visit.
    Studieafslutningen er defineret ved at den sidste af de planlagte 74 forsøgspersoner er inkluderet og har gennemført det sidste besøg.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    It is expected that the vast majority of patients with intracerebral hemorrhage are unconcious or of restricted conciousness and not able to give consent at their own at the time of admission to the hospital.

    Det forventes at langt hovedparten af patienter med intracerebral hæmorragi er bevidsthedspåvirkede ved ankomsten til hospitalet og ikke kan afgive informeret samtykke. Der ansøges den Centrale Videnskabsetiske Komite om tilladelse til auktforsøg
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 74
    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)
    Patient care after the end of the trial will not differ from standard care applied in patients who are not included in this trial.
    Ud over den akutte behandling vil alle patienter modtage vanlig behandling.
    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 Decision2013-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-02-06
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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