Cerebral Hypoperfusion at Transcranial Color-Coded Doppler. (IPOPERT)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Cerebral Injury
• Intervention / Treatment: Diagnostic test: Transcranial Color-Coded Doppler (TCCD)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Anselmo Caricato; Phone Number: +390630153185; Email: anselmo.caricato@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOSD TERAPIA INTENSIVA NEUROCHIRURGICA
      • Principal Investigator: Anselmo Caricato
      • Contact: Anselmo Caricato; Phone Number: +390630153185; Email: anselmo.caricato@policlinicogemelli.it
      • Contact: Luca Pisapia; Email: luca.pisapia@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCCD normalization	To assess the percentage of patients who normalize TCCD cerebral perfusion parameters at each step of the protocol	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICP concordance	To calculate the concordance coefficients between invasively measured ICP values and those obtained through TCCD using the Czosnyka formula	1 hour

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Anselmo Caricato, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 6521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No