Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II

NCT07287358 | Not Yet Recruiting

• 1 other identifier: NL-010951
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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 personalized approach to neurocritical care has never been tested in a randomized controlled study before. If effective in showing reduced brain damage biomarkers, it will fundamentally transform brain injury treatment and dramatically improve recovery outcomes for patients worldwide.

Conditions

Traumatic Brain Injury; Severe Traumatic Brain Injury; Intracranial Pressure; Cerebral Perfusion Pressure

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Cumulative concentrations of biomarkers NSE, UCH-L1, S100B, Tau and NfL during 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

  first five days of ICU admission

• Daily Therapy Intensity Level (TIL) score

  first five days on ICU

• Mean daily Pressure Reactivity Index (PRx) values

  First 5 days on ICU

• Frequency and duration of CPP outside safety limits (50-100 mmHg)

  First 5 days on ICU

Study Arms (2)

CPPopt treatment

EXPERIMENTAL

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.

Other: Optimal cerebral perfusion pressure

Control group

NO INTERVENTION

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.

Interventions

Optimal cerebral perfusion pressure OTHER

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.

Also known as: CPPopt

CPPopt treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known pregnancy
• Moribund at presentation (e.g. bilaterally absent pupillary responses)
• Patients with a primary decompressive craniectomy
• Failure to get final written informed consent

Sponsors & Collaborators

• Medisch Spectrum Twente: collaborator
• Maastricht University Medical Center: lead
• Radboud University Medical Center: collaborator
• Medical Center Haaglanden: collaborator

Study Sites (4)

Medisch Spectrum Twente

Enschede, Netherlands

Location

Maastricht Universitair Medisch Centrum+

Maastricht, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

Related Publications (3)

• Weiss M, Meyfroidt G, Aries MJH. Individualized cerebral perfusion pressure in acute neurological injury: are we ready for clinical use? Curr Opin Crit Care. 2022 Apr 1;28(2):123-129. doi: 10.1097/MCC.0000000000000919.

  PMID: 35058408 BACKGROUND

• Beqiri E, Tas J, Czosnyka M, van Kaam RCR, Donnelly J, Haeren RH, van der Horst ICC, Hutchinson PJ, van Kuijk SMJ, Liberti AL, Menon DK, Hoedemaekers CWE, Depreitere B, Meyfroidt G, Ercole A, Aries MJH, Smielewski P. Does Targeting CPP at CPPopt Actually Improve Cerebrovascular Reactivity? A Secondary Analysis of the COGiTATE Randomized Controlled Trial. Neurocrit Care. 2025 Jun;42(3):937-944. doi: 10.1007/s12028-024-02168-y. Epub 2024 Dec 2.

  PMID: 39623160 BACKGROUND

• Tas J, Beqiri E, van Kaam RC, Czosnyka M, Donnelly J, Haeren RH, van der Horst ICC, Hutchinson PJ, van Kuijk SMJ, Liberti AL, Menon DK, Hoedemaekers CWE, Depreitere B, Smielewski P, Meyfroidt G, Ercole A, Aries MJH. Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial. J Neurotrauma. 2021 Oct 15;38(20):2790-2800. doi: 10.1089/neu.2021.0197. Epub 2021 Aug 16.

  PMID: 34407385 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Marcel Aries, dr.

CONTACT

0031-43-3876387; marcel.aries@mumc.nl

Rik Hendrix, dr.

CONTACT

0031-433874373; rik.hendrix@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized controlled trial

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

NL (4)