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Clinical trials for Craniectomy

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    9 result(s) found for: Craniectomy. Displaying page 1 of 1.
    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: 2017-004698-15 Sponsor Protocol Number: S60859 Start Date*: 2021-05-03
    Sponsor Name:UZ Leuven / KU Leuven
    Full Title: Brain Injury and Ketamine: a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on Therapy Intensity Level and intracranial pressure in acute brain inju...
    Medical condition: Traumatic Brain Injury patients requiring sedation to control the intracranial pressure (ICP).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 2018-003858-24 Sponsor Protocol Number: 252BN201 Start Date*: 2019-08-13
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients with Brain Contusion
    Medical condition: Brain contusion
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10052346 Brain contusion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004854-41 Sponsor Protocol Number: 252LH301 Start Date*: 2018-11-09
    Sponsor Name:Biogen Idec Research Limited
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema followi...
    Medical condition: Cerebral edema following Large Hemispheric Infarction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10008107 Cerebral edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) DK (Prematurely Ended) BE (Completed) PT (Prematurely Ended) ES (Prematurely Ended) HU (Completed) FI (Completed) LT (Completed) IT (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001688-66 Sponsor Protocol Number: SC.14/18-19 Start Date*: 2019-09-09
    Sponsor Name:University of Warwick [...]
    1. University of Warwick
    2. University Hospitals Birmingham NHS Foundation Trust
    Full Title: Sugar or Salt (SOS) trial: Hyperosmolar therapy in traumatic brain injury
    Medical condition: Increased intracranial pressure following traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10060690 Traumatic brain injury LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-005535-40 Sponsor Protocol Number: 3599-001 Start Date*: 2016-07-21
    Sponsor Name:Baxter Healthcare Corporation
    Full Title: A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated (FS VH S/D 500 s-apr) Compared to DuraSeal Dural Sealant as an Adjunct ...
    Medical condition: Intra-operative CSF leak
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10024091 Leakage of cerebrospinal fluid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003716-12 Sponsor Protocol Number: RHNIA-001-2021 Start Date*: 2022-08-24
    Sponsor Name:Rigshospitalet
    Full Title: S-ketamine for cortical spreading depolarisation in patients with severe acute brain injury
    Medical condition: Severe acute brain injury caused by aneurysmal subarachnoid hemorrhage, spontaneous intracerebral hemorrhage or traumatic brain injury.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10018061 General anesthesia LLT
    21.1 100000004865 10070731 Electrocorticography LLT
    20.0 100000004852 10056389 Brain damage LLT
    21.0 100000004852 10019529 Hemorrhage brain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    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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