[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575428":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":41,"locations":10,"responsibleParty":50,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":77,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":10},{"fullName":5,"class":6},"Meditech Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Ventriculostomy",null,"Patients are managed with a standard ventriculostomy procedure connected to an external ventricular drain system.",[13],"Procedure: Ventriculostomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Ventriculostomy + Locking Device","Patients are managed with a ventriculostomy procedure plus a locking system (NTDrain) connected to an external ventricular drain system.",[18],"Procedure: Ventriculostomy + Locking Device",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Ventriculostomy","Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement.",[9],[26,27],"Intraventricular Catheter","External Ventricular Drainage",{"type":21,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is an alternative procedure performed for this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. During the insertion, a locking device is attached and secured at the burr hole defect. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement.",[15],[32,33],"Ventricular Drainage + Locking Device","External Ventricular Catheter + Locking Device",[35,38],{"name":36,"affiliation":5,"role":37},"Andres M Rubiano, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Luigi V Berra, MD","La Sapienza University",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Wendy Gonzalez, MD","CONTACT","+576023720672","gonzalez.wendy.meditechf@outlook.com",{"name":48,"role":44,"phone":45,"phoneExt":10,"email":49},"Santiago Cardona, MD","cardona.santiago.meditechf@outlook.com",{"type":37,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Andres M. Rubiano","Principal Investigator","100575428","security-and-effectiveness-assessment-of-locking-systems-in-ventriculostomy-for-traumatic-brain-injury-100575428",false,"NCT06772155","Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury","A Comparative Effectiveness Study on Catheter Locking Device Versus Standard Ventriculostomy for Surgical Management of Traumatic Brain Injury Patients With Intracranial Compartment Syndrome","SEALS-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal Computed Tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3 mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm on the same side of the CT´s primary injury and\u002For an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Medium Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Wave Form (ICPWF)2 \\> ICPWF1 waveform pattern on the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Ventriculostomy surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler, and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Ventriculostomy surgical procedures performed \\> 24 hours after the trauma.","ALL","18 Years","70 Years",{"count":65,"type":66},292,"ESTIMATED","24 Months","OBSERVATIONAL","This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and\u002For reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.",[71,72],"Traumatic Brain Injuries","Intracranial Hypertension",[74,75,76],"External Ventricular Drain","Traumatic Brain Injury","Cranial Compartment Syndrome","NOT_YET_RECRUITING","2025-05-05",{"date":80,"type":81},"2025-05-08","ACTUAL",{"date":83,"type":66},"2025-07-05",{"date":85,"type":66},"2027-12-31",{"name":5,"class":6}]