Heart Defects, CongenitalTCEUSNCT03215628
Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery
A study testing TCEUS in people with Heart Defects, Congenital, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- TCEUS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2017to 30 Aug 2021
- Phase
- Interventional
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery
Erlangen, 91054
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Defects, Congenital
- Being tested
- TCEUS
- Keywords
- CEUS, TCEUS, contrast enhanced ultrasound, perfusion, cerebral perfusion, sulphur hexafluoride, SonoVue
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCEUSDiagnostic test
Also called Transcranial contrast-enhanced ultrasound
Intravenous sulphur hexafluoride microbubbles
| Study group | Role | What they receive |
|---|---|---|
| Group A - TCEUS with HLM | Active comparator | General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts) Receives: Diagnostic Test: TCEUS |
| Group B - TCEUS with HLM | Experimental | Surgery of the aortic arc Receives: Diagnostic Test: TCEUS |
| Group C - TCEUS without HLM | Active comparator | Neonatal cardiac surgery without HLM Receives: Diagnostic Test: TCEUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Secondary outcomes (15)
Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Measured: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start4 Jul 2017
- Primary completion30 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Rüffer, MD, Principal investigator, University Hospital Erlangen, Department of Pediatric Cardiac SurgeryJörg Jüngert, MD, Principal investigator, University Hospital Erlangen, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215628
- Sponsor's protocol ID
- 20_17B
- Acronym
- TCEUS
- Status last verified
- Nov 2020
- First submitted
- 4 Jul 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Knieling F, Cesnjevar R, Regensburger AP, Wagner AL, Purbojo A, Dittrich S, Munch F, Neubert A, Woelfle J, Jungert J, Ruffer A. Transfontanellar Contrast-enhanced US for Intraoperative Imaging of Cerebral Perfusion during Neonatal Arterial Switch Operation. Radiology. 2022 Jul;304(1):164-173. doi: 10.1148/radiol.212044. Epub 2022 Apr 5.
PubMed 35380495Ruffer A, Knieling F, Cesnjevar R, Regensburger A, Purbojo A, Dittrich S, Munch F, Wolfle J, Jungert J. Equal cerebral perfusion during extended aortic coarctation repair. Eur J Cardiothorac Surg. 2022 Jan 24;61(2):299-306. doi: 10.1093/ejcts/ezab415.
PubMed 34718510
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall
- ClinicalTrials.gov ID
- NCT03215628
- Acronym / sponsor ID
- TCEUS / 20_17B
- Conditions
- Heart Defects, Congenital
- Keywords
- CEUS, TCEUS, contrast enhanced ultrasound, perfusion, cerebral perfusion, sulphur hexafluoride, SonoVue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Jul 2017 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - TCEUS with HLM | Active comparator | Diagnostic Test: TCEUSGeneral neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts) |
| Group B - TCEUS with HLM | Experimental | Diagnostic Test: TCEUSSurgery of the aortic arc |
| Group C - TCEUS without HLM | Active comparator | Diagnostic Test: TCEUSNeonatal cardiac surgery without HLM |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TCEUSAlso: Transcranial contrast-enhanced ultrasoundIntravenous sulphur hexafluoride microbubbles | Diagnostic test | Group A - TCEUS with HLM, Group B - TCEUS with HLM, Group C - TCEUS without HLM |
Primary outcome
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
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
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
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
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
15 secondary outcomes
Time-To-Peak (TTP)
Time frame: 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)
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)
Mean-Transit-Time (MTT)
Time frame: 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)
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)
Maximum Intensity (MI)
Time frame: 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)
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 Blood Volume (RBV)
Time frame: 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 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 Blood Flow (RBF)
Time frame: 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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 35380495Knieling F, Cesnjevar R, Regensburger AP, Wagner AL, Purbojo A, Dittrich S, Munch F, Neubert A, Woelfle J, Jungert J, Ruffer A. Transfontanellar Contrast-enhanced US for Intraoperative Imaging of Cerebral Perfusion during Neonatal Arterial Switch Operation. Radiology. 2022 Jul;304(1):164-173. doi: 10.1148/radiol.212044. Epub 2022 Apr 5.
- Derived from this study: PubMed 34718510Ruffer A, Knieling F, Cesnjevar R, Regensburger A, Purbojo A, Dittrich S, Munch F, Wolfle J, Jungert J. Equal cerebral perfusion during extended aortic coarctation repair. Eur J Cardiothorac Surg. 2022 Jan 24;61(2):299-306. doi: 10.1093/ejcts/ezab415.
- Individual participant dataSharing planned: Undecided
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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.
André Rüffer, MD principal investigator
University Hospital Erlangen, Department of Pediatric Cardiac Surgery
Jörg Jüngert, MD principal investigator
University Hospital Erlangen, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCEUS in people with Heart Defects, Congenital, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-To-Peak (TTP) (time frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215628, which also lists 2 linked publications.
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 29 Sep 2021.