Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06607211

Cerebral Hypoperfusion at Transcranial Color-Coded Doppler.

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Rome, Lazio, 00168, Italy

Location contact

Anselmo Caricato

CONTACT

[email protected]

+390630153185

Anselmo Caricato

PRINCIPAL_INVESTIGATOR

Luca Pisapia

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. TCCD normalization

    Time frame: 1 hour

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

Secondary outcomes

  1. ICP concordance

    Time frame: 1 hour

    To calculate the concordance coefficients between invasively measured ICP values and those obtained through TCCD using the Czosnyka formula

Study contacts

Contact information is provided by the study sponsor or research team.

Anselmo Caricato

CONTACT

[email protected]

+390630153185

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Cerebral Hypoperfusion at Transcranial Color-Coded Doppler. Effects of a Treatment Protocol in Patients With Acute Brain Injury

Acronym: IPOPERT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

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.