NCT06772155Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. máj. 8. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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/or 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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 292 (tervezett)
- Első benyújtás
- 2025. jan. 7.
- Kezdés
- 2025. júl. 5.
- Elsődleges befejezés
- 2027. jún. 30.
- Fő szponzor
- Meditech Foundation
- NCT-szám
- NCT06772155
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 292
- 2025. júl. 5. és az elsődleges befejezés (2027. jún. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Ventriculostomy surgical procedures performed > 24 hours after the trauma.
Életkor
- Age less than 18 or more than 70 years old.
Egyéb
- TBI patients arriving at the emergency room after 24 hours following trauma.
- Normal CT scan at the emergency room.
- 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/or non-invasive ICP waveform analyzer).
- Polytrauma or massive brain injury with survival expectancy < 24 hours.
Kiket keres a vizsgálat
- TBI patients arriving at the emergency room in the first 24 hours following trauma.
- 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/or an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or/and a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) > 1.3 and/or Medium Cerebral Artery - Diastolic Velocity (MCA-DV) < 20cm/seg on the same side of the CT´s primary injury or/and an Intracranial Pressure Wave Form (ICPWF)2 > ICPWF1 waveform pattern on the same side of the CT´s primary injury).
- Age 18 to 70 years old.
- Patients with or without polytrauma with survival expectancy >24 hours.
- Ventriculostomy surgical procedures less than 24 hours after the trauma.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.