Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Study title: Pediatric patients treatted in the Rosou Study In the Baxter clinical study 014/015, also published by Rousou, which was the pivotal study of the primary BLA submission, 26 of the randomized patients were below 18 years old (7 days – 16 years). Twenty-one of these patients were in the fibrin sealant group, 5 in the control group. Of the 21 patients in the fibrin sealant group 17 (80.9%) achieved hemostasis within 5 minutes and were rated a success, while of the 5 control patients only 1 (20%) achieved time to hemostasis within 5 minutes.

    Type of medicine: Medicines containing chemical active substances
    Therapeutic area: Hemic and Lymphatic Diseases [C15] 
    Brands: Please see report, Please see report, Please see report
    MAH holders: Please see report, Please see report, Please see report
    Assessment:
    Active substance: FIBRINOGEN 70 - 110 MG/ML + PLASMAFIBRONECTIN 2-9 MG/ML +FACTOR XIII 10-50 U/ML+ PLASMINOGEN 0.04 - 0.12 MG/ML+ APROTININ 3000 KIU/ML+ THROMBIN 4 IU/ML+ THROMBIN 500 IU/ML+ CALCIUM CHLORIDE 5.88 MG/ML
    ATC code:
    Document link:
    Document date:
    Study number: 014/016
    EudraCT number:
    Scope of study: Clinical
    Population of study subjects: Preterm newborn Infants Newborn infants (1 to 27 days) Infants and toddlers (28 days to 24 months) Children (2 to 11 years) Adolescents (12 to 18 years)
    - - - - -
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 31 23:09:46 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA