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Clinical Trial NCT07287358 (Cogitate II) for Traumatic Brain Injury, Severe Traumatic Brain Injury, Intracranial Pressure, Cerebral Perfusion Pressure is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II (Cogitate II) 60 Biomarker-Driven Randomized Personalized Treatment
Clinical Trial NCT07287358 (Cogitate II) is an interventional study for Traumatic Brain Injury, Severe Traumatic Brain Injury, Intracranial Pressure, Cerebral Perfusion Pressure and is currently not yet recruiting. Enrollment is planned to begin on 1 May 2026 and continue until the study accrues 60 participants. Led by Maastricht University Medical Center, this study is expected to complete by 15 May 2028. The latest data from ClinicalTrials.gov was last updated on 6 January 2026.
Brief Summary
After severe traumatic brain injury, adequate blood flow to the brain is essential for recovery. This depends on arterial blood pressure, yet intensive care units apply fixed targets to all patients - treating every brain and patient the same. This study aims to change that. With new technology, 'optimal' blood pressure can be determined for each individual brain and treatment can be tailored accordingly. This person...Show More
Detailed Description
Rationale: In traumatic brain injury patients with intracranial pressure monitoring (TBIicp), individual optimal cerebral perfusion pressure (also called CPPopt) can be determined based on continuous cerebral autoregulation information. In a 2021 study, CPPopt guided management has been demonstrated to be both feasible and safe in clinical practice. This study was performed in 4 European countries and coordinated by ...Show More
Official Title
CPPopt Guided Therapy: Assessment of Target Effectiveness - II
Conditions
Traumatic Brain InjurySevere Traumatic Brain InjuryIntracranial PressureCerebral Perfusion PressurePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- Cogitate II
- NL-010951
NCT ID Number
Start Date (Actual)
2026-05-01
Last Update Posted
2026-01-06
Completion Date (Estimated)
2028-05-15
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
CPPopt
optimal cerebral perfusion pressure
pressure reactivity index
PRx
Intracranial pressure
cerebral perfusion pressure
traumatic brain injury
severe traumatic brain injury
cogitate
cogitate-II
optimal cerebral perfusion pressure
pressure reactivity index
PRx
Intracranial pressure
cerebral perfusion pressure
traumatic brain injury
severe traumatic brain injury
cogitate
cogitate-II
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCPPopt treatment The CPPopt treatment group will receive management according to the Brain Trauma Foundation (BTF) guidelines, except for the targeted cerebral perfusion pressure. Here, the calculated "optimal cerebral perfusion pressure (CPPopt)" will be targeted, with updated CPPopt targets every 4 hours. | Optimal cerebral perfusion pressure The intervention group will receive CPPopt guided management with updated CPPopt targets every 4 hours. All other parameters will be handled according to Brain Trauma Foundation (BTF) guidelines. |
No InterventionControl group The intervention group will receive standard brain trauma management according to the Brain Trauma Foundation (BTF) guidelines, including the standard cerebral perfusion pressure target of 60-70 mmHg. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cumulative concentration of blood biomarker Glial Fibrillary Acidic Protein (GFAP) during first 5 days of ICU admission | The cumulative release of blood biomarker Glial Fibrillary Acidic Protein (GFAP) over the first five days of ICU admission, quantified as the area under the curve (AUC) in both groups | The first 5 days of ICU admission |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cumulative concentrations of biomarkers NSE, UCH-L1, S100B, Tau and NfL during first 5 days of ICU admission | The cumulative release of five additional brain injury biomarkers: Neuron Specific Enolase (NSE), Ubiquitin C-terminal hydrolase L1 (UCH-L1), S100 calcium-binding protein B (S100B), Tau, and Neu-rofilament light chain (NfL) over the first 5 days of ICU admission. | the first 5 days of ICU admission |
Progression of cerebral edema on CT imaging based on size of hypodense regions in sequential CT scans | Cerebral edema progression will be quantified by comparing brain CT scans obtained at admission with follow-up scans within the first five days of ICU admission (performed when clinically indicated). | first five days of ICU admission |
Daily Therapy Intensity Level (TIL) score | Daily intracranial hypertenstion Therapy Intensity Level (TIL) score during the first five days on ICU to test whether our intervention reduces the need for aggressive treatment of increased ICP.
Individual ICP-targeting therapies were assigned a score based on published estimates of their relative efficacy and risks of morbidity. The TIL includes eight ICP-treatment modalities, termed items. The maximum score is 38, with a higher score indicating that a patient is receiving more complex, aggressive, or frequent treatments. | first five days on ICU |
Mean daily Pressure Reactivity Index (PRx) values | Mean daily Pressure Reactivity Index (PRx) values will be calculated as a global measure of cerebral autoregulation. PRx is defined as the moving correlation coefficient between slow waves of ABP and ICP, with more positive values indicating impaired autoregulation. | First 5 days on ICU |
Frequency and duration of CPP outside safety limits (50-100 mmHg) | Frequency and cumulative duration of CPP excursions outside the predefined safety limits (CPP between 50 mmHg and 100 mmHg) during the first five days will be recorded for each patient. These data will be used to evaluate the safety of CPPopt guided management compared to standard care, by quantifying both the number and total time of CPP deviations beyond clinically acceptable thresholds. | First 5 days on ICU |
Glasgow Coma Score at the moment of intensive care unit discharge | Glasgow Coma Score at ICU discharge will be recorded as an early indicator of patient outcome.
The Glasgow Coma Scale (GCS) is a clinical diagnostic tool widely used since the 1970s to roughly assess an injured person's level of brain damage. The GCS diagnosis is based on a patient's ability to respond and interact with three kinds of behaviour: eye movements, speech, and other body motions. A GCS score can range from 3 (completely unresponsive) to 15 (responsive). The higher the value, the better the neurological state. | At the moment a patient is discharged from ICU, assessed up to 2 months after ICU admission |
ICU mortality at the moment of ICU discharge | ICU mortality will also be recorded as an early indicator of patient outcome. Patients dying will be registered as "dead", patients who are alive at ICU discharge will be registered as "survival". | At time of death, or if survival: at the moment the patient is discharged from ICU, assessed up to 2 months after ICU admission |
Non-invasive near-infrared spectroscopy (NIRS) values | Non-invasive near-infrared spectroscopy (NIRS) values will be recorded using bifrontal sensors to estimate cerebral oxygenation. NIRS provides a non-invasive measure of cerebral perfusion, as changes in cerebral oxygenation correlate with changes in cerebral blood flow | First 5 days on ICU |
Progression of cerebral hematoma on CT imaging based on size of hyperdense regions in sequential CT scans | Cerebral hematoma progression will be quantified by comparing brain CT scans obtained at admission with follow-up scans within the first five days of ICU admission (performed when clinically indicated). | First 5 days of ICU admission |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adult (>18 years old)
- Severe TBI requiring ICP-directed therapy for at least 24 hrs on the assessment of the recruiting intensive care team and/or attending neurosurgeon
- Start randomization within 24 hrs after ICU admission.
- Known pregnancy
- Moribund at presentation (e.g. bilaterally absent pupillary responses)
- Patients with a primary decompressive craniectomy
- Failure to get final written informed consent
- 🏛️Medisch...
Study Central Contact
Contact: Marcel Aries, dr., 0031-43-3876387, [email protected]
Contact: Rik Hendrix, dr., 0031-433874373, [email protected]
4 Study Locations in 1 Countries
Medisch Spectrum Twente, Enschede, Netherlands
Beishuizen, dr., Contact, 053 - 4872000, [email protected]
Maastricht Universitair Medisch Centrum+, Maastricht, Netherlands
Marcel Aries, dr., Contact, 0031-434876583, [email protected]
Rik Hendrix, dr., Contact, 0031-433874373, [email protected]
Radboud University Medical Center, Nijmegen, Netherlands
Hoedemaekers, dr., Contact, 024 - 361727 3, [email protected]
Haaglanden Medisch Centrum, The Hague, Netherlands
Van Vliet, dr., Contact, 088 - 979 2119, [email protected]
Contact, [email protected]