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Clinical trials for Cranial sutures

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   44363   clinical trials with a EudraCT protocol, of which   7387   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 ).  
     
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    6 result(s) found for: Cranial sutures. Displaying page 1 of 1.
    EudraCT Number: 2013-001056-35 Sponsor Protocol Number: TXA Start Date*: 2014-11-24
    Sponsor Name:IRCCS Istituto Giannina Gaslini
    Full Title: The Effectiveness and Population Pharmacokinetics and Pharmacogenomics of a Reduced Dose of Tranexamic Acid for Craniosynostosis Surgery: A multicenter study. The TXA Study.
    Medical condition: craniosynostosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10049889 Craniosynostosis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000545-22 Sponsor Protocol Number: 2012/462. Start Date*: 2015-08-05
    Sponsor Name:Aarhus University hospital
    Full Title: Effects of Tranexamic Acid on on Intra- and Postoperative bleeding, Blood transfusion and Coagulation in Children Undergoing Craniosynostosis Surgery
    Medical condition: Bleeding during paediatric Craniosynostosis surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10049889 Craniosynostosis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003558-26 Sponsor Protocol Number: BIOS-13-006 Start Date*: 2014-07-21
    Sponsor Name:Ethicon Inc
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating the Safety and Efficacy of EVICEL® used for Suture-line sealing in Dura-Mater Closure during Paediatric Neurosurgical Cranial Procedures
    Medical condition: Subjects undergoing neurosurgical cranial procedures, requiring water-tight closures (suture-line sealing) in dura-mater during the surgery
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2014-003954-15 Sponsor Protocol Number: BIOS-14-002 Start Date*: 2015-05-06
    Sponsor Name:Ethicon, Inc.
    Full Title: A single blinded, randomized, controlled study to evaluate the safety and effectiveness of EVICEL® Fibrin sealant (Human) compared to a Hydrogel sealant as an adjunct to sutured dural repair
    Medical condition: Cerebrospinal fluid leakage in posterior fossa or supratentorial procedures (craniectomy or craniotomy) during neurosurgery
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016501-41 Sponsor Protocol Number: 400-09-001 Start Date*: 2010-06-29
    Sponsor Name:Omrix Biopharmaceuticals Ltd
    Full Title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair
    Medical condition: tissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed) FI (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-002287-24 Sponsor Protocol Number: 201105-RCTTEG Start Date*: 2012-07-11
    Sponsor Name:Erasmus MC
    Full Title: Massive blood loss in children during multiple trauma or major surgery: Fibrinogen therapy for massive blood loss during elective surgery for craniosynostosis repair, a double blinded randomized c...
    Medical condition: massive blood loss in surgery for premature fusion of cranial sutures, massive blood loss in fused bones of the skull
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004866 10005645 Blood loss of (NOS) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
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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
    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.

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