Cerebral InjuryIPOPERTNCT06607211
Cerebral Hypoperfusion at Transcranial Color-Coded Doppler.
An observational study of Cerebral Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Injury
- What is being tested?
- Transcranial Color-Coded Doppler (TCCD)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with severe acute brain injury in a coma admitted to the Emergency Department or Intensive Care Unit will be subjected to TCCD as routinely done as part of clinical practice.
Who may be able to join
- Age over 18 years
- Patients with intraparenchymal cerebral hemorrhage, subarachnoid hemorrhage, head trauma, or hydrocephalus
- Glasgow Coma Scale belowe 9
- Need for invasive mechanical ventilation
- Arterial catheter for invasive blood pressure monitoring and blood sampling
- Presence of Doppler parameters of cerebral hypoperfusion (concurrent presence of two or more of the following conditions: PI > 1.4, diastolic velocity < 20 cm/s, and mean velocity < 30 cm/s detected in at least one middle cerebral artery)
Who cannot join
- Absence of transtemporal windows bilaterally on TCCD
- Documented severe aortic valve insufficiency
- Heart rate less than 40 bpm
- Patients with suspected vasospasm on TCCD
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOSD TERAPIA INTENSIVA NEUROCHIRURGICA
Rome, Lazio, 00168
Anselmo Caricato, +390630153185, anselmo.caricato@policlinicogemelli.it
Luca Pisapia, luca.pisapia@policlinicogemelli.it
About this study
Official title: Cerebral Hypoperfusion at Transcranial Color-Coded Doppler. Effects of a Treatment Protocol in Patients With Acute Brain Injury
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.
Read more
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.
- Conditions
- Cerebral Injury
- Being tested
- Transcranial Color-Coded Doppler (TCCD)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Color-Coded Doppler (TCCD)Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
TCCD normalization
To assess the percentage of patients who normalize TCCD cerebral perfusion parameters at each step of the protocol
Measured: 1 hour
Secondary outcomes (1)
ICP concordance
To calculate the concordance coefficients between invasively measured ICP values and those obtained through TCCD using the Czosnyka formula
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anselmo Caricato, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607211
- Sponsor's protocol ID
- 6521
- Acronym
- IPOPERT
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Hypoperfusion at Transcranial Color-Coded Doppler. Effects of a Treatment Protocol in Patients With Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06607211
- Acronym / sponsor ID
- IPOPERT / 6521
- Conditions
- Cerebral Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with severe acute brain injury in a coma admitted to the Emergency Department or Intensive Care Unit will be subjected to TCCD as routinely done as part of clinical practice.
Key inclusion criteria (6 listed)
- Age over 18 years
- Patients with intraparenchymal cerebral hemorrhage, subarachnoid hemorrhage, head trauma, or hydrocephalus
- Glasgow Coma Scale belowe 9
- Need for invasive mechanical ventilation
- Arterial catheter for invasive blood pressure monitoring and blood sampling
Key exclusion criteria (4 listed)
- Absence of transtemporal windows bilaterally on TCCD
- Documented severe aortic valve insufficiency
- Heart rate less than 40 bpm
- Patients with suspected vasospasm on TCCD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Color-Coded Doppler (TCCD)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. | Diagnostic test | – |
Primary outcome
TCCD normalization
Time frame: 1 hour
To assess the percentage of patients who normalize TCCD cerebral perfusion parameters at each step of the protocol
1 secondary outcome
ICP concordance
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anselmo Caricato principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anselmo Caricato (+390630153185, anselmo.caricato@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCCD normalization (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.