Cerebrovascular CirculationNCT03484104
Cerebral Perfusion in Hypothermic Circulatory Arrest
An observational study of Cerebrovascular Circulation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- Measurement of tissue oxygenation index (TOI)
- How many people
- 40 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jul 2018to 28 Sep 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population scheduled for elective aortic arch surgery.
Who may be able to join
- Age 18 years or older
- Elective cardiac surgery with cardiopulmonary bypass
- Hypothermic circulatory arrest
- General informed consent signed
Who cannot join
- Severe stenotis in cerebral arteries
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Inselspital, University Hospital Bern, University of Bern
Bern, 3010
University of Bern
Bern, 3010
About this study
Official title: Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest
Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.
- Conditions
- Cerebrovascular Circulation
- Being tested
- Measurement of tissue oxygenation index (TOI)
- Keywords
- Cardiopulmonary bypass, Hypothermic circulatory arrest, Aortic arch surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of tissue oxygenation index (TOI)Diagnostic test
Also called Measurement of mean blood flow velocity in the middle cerebral artery (Vmca)
TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest
| Study group | Role | What they receive |
|---|---|---|
| Hypothermic circulatory arrest | Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion Receives: Diagnostic Test: Measurement of tissue oxygenation index (TOI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOI
The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Vmca
The secondary outcome is the mean blood flow velocity in the middle cerebral artery at sACP the specified flow rates in comparison to the VmMCA during general anesthesia, after anesthesia induction.
Measured: through study completion, an average of 1 year
Neurologic accidents
An additional secondary outcome measure are any neurologic accidents during the same hospital stay.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Jul 2018
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabor Erdös, Insel Gruppe AG, University Hospital Bern
- Investigators
- Gabor Erdoes, MD PhD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484104
- Sponsor's protocol ID
- 2017-02216
- Other IDs
- 2017
- Status last verified
- Sep 2021
- First submitted
- 16 Mar 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest
- ClinicalTrials.gov ID
- NCT03484104
- Acronym / sponsor ID
- 2017-02216
- Conditions
- Cerebrovascular Circulation
- Keywords
- Cardiopulmonary bypass, Hypothermic circulatory arrest, Aortic arch surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 30 Mar 2018 (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.
Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothermic circulatory arrest | – | Diagnostic Test: Measurement of tissue oxygenation index (TOI)Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population scheduled for elective aortic arch surgery.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Elective cardiac surgery with cardiopulmonary bypass
- Hypothermic circulatory arrest
- General informed consent signed
Key exclusion criteria (1 listed)
- Severe stenotis in cerebral arteries
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 |
|---|---|---|
| Measurement of tissue oxygenation index (TOI)Also: Measurement of mean blood flow velocity in the middle cerebral artery (Vmca)TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest | Diagnostic test | Hypothermic circulatory arrest |
Primary outcome
TOI
Time frame: through study completion, an average of 1 year
The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake.
2 secondary outcomes
Vmca
Time frame: through study completion, an average of 1 year
Neurologic accidents
Time frame: through study completion, an average of 1 year
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.
- Individual participant dataSharing planned: No
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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.
Gabor Erdoes, MD PhD principal investigator
University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Circulation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 4 inclusion and 1 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 2 sites in Switzerland. 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?
TOI (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.