Cerebral Hypoperfusion at Transcranial Color-Coded Doppler.

NCT06607211 | Not Yet Recruiting

• 1 other identifier: 6521
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Injury

Outcome Measures

Primary Outcomes (1)

• TCCD normalization

  To assess the percentage of patients who normalize TCCD cerebral perfusion parameters at each step of the protocol

  1 hour

Secondary Outcomes (1)

• ICP concordance

  1 hour

Interventions

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.

Eligibility Criteria

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

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.

You may qualify if:

• 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)

You may not qualify if:

• Absence of transtemporal windows bilaterally on TCCD
• Documented severe aortic valve insufficiency
• Heart rate less than 40 bpm
• Patients with suspected vasospasm on TCCD

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOSD TERAPIA INTENSIVA NEUROCHIRURGICA

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Anselmo Caricato

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anselmo Caricato

CONTACT

+390630153185; anselmo.caricato@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 31, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

IT (1)