Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery (TCEUS)

September 28, 2021 updated by: University of Erlangen-Nürnberg Medical School

Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall

Transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during pediatric cardiac surgery. This study is aimed as a feasibility study prior to conducting a lager prospective clinical trial including neurologic and developmental outcome measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The cerebral perfusion of infants with congenital heart defects is a critical determinant during cardiac surgery. The majority of these interventions is performed during deep or moderate hypothermia (25-32°C) with reduced blood flow of the heart-lung-machine (HLM). Assuming a symmetrical anatomy of the cerebral arteries (C. Willisii) a single vessel (T. brachiocephalicus) is then supplying the cerebral blood flow. Using contrast-enhanced ultrasound the cerebral blood flow will be assessed during cardiac surgery interventions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neonates and infants ≤ 4 month (open fontanelle)
  • Proper ultrasound conditions/window
  • Appropriate general and neurologic state of health
  • Written consent of both parents/guardians
  • Availability of trained sonographer (medical doctor)

Exclusion Criteria:

  • Absence of trained sonographer (medical doctor)
  • Intolerance against SonoVue® (bzw. sulphur hexafluoride)
  • Missing signed consent
  • Reduced or inappropriate general and neurologic state of health
  • Preexisting cerebral injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A - TCEUS with HLM
General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts)
Diagnostic test: TCEUS
Intravenous sulphur hexafluoride microbubbles
Other Names:
  • Transcranial contrast-enhanced ultrasound
Experimental: Group B - TCEUS with HLM
Surgery of the aortic arc
Diagnostic test: TCEUS
Intravenous sulphur hexafluoride microbubbles
Other Names:
  • Transcranial contrast-enhanced ultrasound
Active Comparator: Group C - TCEUS without HLM
Neonatal cardiac surgery without HLM
Diagnostic test: TCEUS
Intravenous sulphur hexafluoride microbubbles
Other Names:
  • Transcranial contrast-enhanced ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-To-Peak (TTP)
Time Frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Mean-Transit-Time (MTT)
Time Frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Maximum Intensity (MI)
Time Frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative Blood Volume (RBV)
Time Frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative Blood Flow (RBF)
Time Frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-To-Peak (TTP)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Time-To-Peak (TTP)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Time-To-Peak (TTP)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Mean-Transit-Time (MTT)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Mean-Transit-Time (MTT)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Mean-Transit-Time (MTT)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Maximum Intensity (MI)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Maximum Intensity (MI)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Maximum Intensity (MI)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative Blood Volume (RBV)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative Blood Volume (RBV)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative Blood Volume (RBV)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative Blood Flow (RBF)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative Blood Flow (RBF)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative Blood Flow (RBF)
Time Frame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: André Rüffer, MD, University Hospital Erlangen, Department of Pediatric Cardiac Surgery
  • Principal Investigator: Jörg Jüngert, MD, University Hospital Erlangen, Department of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20_17B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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