Fondazione Policlinico Universitario A. Gemelli IRCCS, UOSD TERAPIA INTENSIVA NEUROCHIRURGICA
Rome, Lazio, 00168, Italy
Location contact
Anselmo Caricato
CONTACT
Anselmo Caricato
PRINCIPAL_INVESTIGATOR
Luca Pisapia
CONTACT
NCT Number: NCT06607211
Background. Cerebral ischemia is a major secondary factor contributing to worsening outcomes in patients with acute brain injuries. Transcranial Color-Coded Doppler (TCCD) is a reliable method for evaluating cerebral perfusion and is recommended for use in emergency settings to reduce secondary injuries. However, there is no established treatment protocol for managing cerebral hypoperfusion as detected by TCCD.
Objective. The primary objective of this study is to assess the efficacy of individual steps in a standardized treatment protocol to normalize TCCD parameters in patients with cerebral hypoperfusion. The secondary objective is to investigate the concordance between invasive intracranial pressure (ICP) measurements and those estimated through TCCD using the Czosnyka formula.
Methods. This prospective multicenter observational study will enroll patients with acute brain injury admitted in emergency or intensive care settings. Inclusion criteria include age over 18, Glasgow Coma Scale <9, and evidence of cerebral hypoperfusion based on TCCD performed on M1 tract of at least one middle cerebral artery. The hypoperfusion is defined as the concurrent presence of at least two of the following parameters: mean velocity below 30 cm/s, diastolic velocity below 20 cm/s, pulsatility index above 1.4.
Patients will undergo a stepwise treatment approach involving normocapnia verification, autoregulation testing increasing mean arterial pressure by 10 mmHg, and hyperosmolar therapy. The effectiveness of each intervention will be assessed by TCCD readings.
Endpoints. The primary endpoint is the percentage of patients who normalize cerebral perfusion parameters at each step of the protocol. The secondary endpoint is the concordance between invasive ICP measurements and those estimated through TCCD.
Sample Size. The study aims to recruit 100 patients over 24 months. Data analysis will include descriptive statistics, with significant results considered at p < 0.05.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Rome, Lazio, 00168, Italy
Anselmo Caricato
CONTACT
Anselmo Caricato
PRINCIPAL_INVESTIGATOR
Luca Pisapia
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
As part of the clinical practice, the examination will be performed with ultrasound machines that have presets for TCCD, using a low-frequency sector probe (2-25 MHz) with a transtemporal approach to obtain a scan through the midbrain plane. Through the use of Color Doppler and Pulsed-Wave Doppler, a spectral doppler waveform of the M1 segment of the middle cerebral artery velocity is obtained bilaterally. If hypoperfusion signs are discovered, TCCD will be repeated to assess the effects of each intervention.
Time frame: 1 hour
To assess the percentage of patients who normalize TCCD cerebral perfusion parameters at each step of the protocol
Time frame: 1 hour
To calculate the concordance coefficients between invasively measured ICP values and those obtained through TCCD using the Czosnyka formula
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Cerebral Hypoperfusion at Transcranial Color-Coded Doppler. Effects of a Treatment Protocol in Patients With Acute Brain Injury
Acronym: IPOPERT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05931250
Brain Diseases, Brain Injuries
Linköping, Other / Non-US, Sweden
View Trial DetailsNCT06018545
Acute Ischemic Stroke, Brain Diseases
London, United Kingdom
View Trial DetailsNCT04696523
Brain Diseases, Brain Infarction
Helsinki, Finland
View Trial DetailsNCT03394248
Brain Diseases, Brain Injuries
Old Westbury, New York, United States
View Trial Details