D000784CARTANCT04962646
CARbon Dioxide Flooding to Reduce Postoperative Neurological Injury Following Surgery for Acute Type A Aortic Dissection
A study testing Carbon dioxide flooding in people with D000784 and D020521, run by Region Skane at 1 site in Sweden.
Trial summary
Aortic dissection is a life-threatening condition and a consequence of a tear of the innermost of the three aortic layers- the intima. When a tear occurs, blood surges through the tear and causes the flow of blood between the aortic layers, causing a "false lumen". Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Carbon dioxide flooding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Verified acute type A aortic dissection.
- Patient accepted for surgical repair.
Who cannot join
- New-onset neurological symptoms defined as focal neurological symptoms or altered state of consciousness at time of inclusion.
- History of stroke with permanent neurological deficiency.
- Previous cardiac surgery.
- Surgery performed with cross clamping of the aorta without open distal anastomosis or open inspection of the distal aorta.
- Presence of implants or devices not compatible with Magnetic Resonance Imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital
Lund
Igor Zindovic, MD, PhD, 0046702202051, Igor.zindovic@med.lu.se
Jacob Ede, 004646171000, Jacob.ede@med.lu.se
About this study
Official title: CARbon Dioxide Flooding to Reduce Postoperative Neurological Injury Following Surgery for Acute Type A Aortic Dissection - A Prospective, Randomized, Blinded, Controlled Clinical Trial
Aortic dissection is a life-threatening condition and a consequence of a tear of the innermost of the three aortic layers- the intima. When a tear occurs, blood surges through the tear and causes the flow of blood between the aortic layers, causing a "false lumen". This causes a weakening of the aortic wall and hinders the blood from reaching its target organs and life saving emergent surgery is performed as routine.
Approximately 20% of patients undergoing acute type a aortic dissection (ATAAD) surgery suffer from postoperative neurological injuries and It has been demonstrated that neurological injuries account for 10-15% of in-hospital deaths.
Read more
In association with other cardiac procedures where the left side of the heart is opened and air may be trapped within the arterial circulation, carbon dioxide flooding is used to displace open air from the surgical wound. In comparison to air, carbon dioxide is significantly more soluble in blood and may therefore decrease the risk of air embolism. In cardiac surgery, carbon dioxide flooding has been demonstrated to reduce levels of biomarkers of cerebral injury, but carbon dioxide is not routinely employed in ATAAD surgery and has not been studied in association with these procedures.
The hypothesis is that carbon dioxide flooding reduces cerebral air embolism and the aim of this project is to evaluate whether carbon dioxide flooding may reduce neurological injuries following ATAAD surgery.
This is a prospective, randomized, controlled, patient- and reviewer blinded interventional study. Patients will be randomized to undergo surgery with carbon-dioxide flooding at 5L/min to the open chest cavity or conventional surgery without carbon dioxide flooding. Remaining aspects of the procedure will be identical.
The patient, external statistician and the reviewer analyzing the primary endpoints will be blinded for the randomization arms.
The study will assess the following endpoints:
Primary outcomes: Presence, number and volume of ischaemic lesions observed using magnetic resonance imaging (MRI) after ATAAD surgery.
Secondary outcomes: Clinical signs of neurological injury. Levels of biomarkers of neurological injury (S100B, neuron specific enolase (NSE) , neurofilament protein (NFL), Glial fibrillary acid protein (GFAP) , Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and Tau-protein (TAU)) before and after surgery. Quality of life, postoperative recovery and neurological function after ATAAD surgery. Primary outcomes in relation to retrograde cerebral perfusion.
Start of inclusion is anticipated to start Jan 1st, 2022. The writing of a manuscript describing the study methods and study objectives is expected to be started in 2021 and the final manuscript is expected to be written during 2025.
An interim analysis of the primary endpoints and the safety arm will be performed after 40 patients have been randomized. An external statistician together with the principle investigator will hereafter decide for the study to be continued or terminated due to harms, futility or superiority.
The safety arm will include intraoperative mortality, in-hospital mortality, re-operation for bleeding, stroke, myocardial infarction or other thromboembolic events.
Update August 2023:
Interim analyses were performed after 40 study participants had been included. Results from the interim analyses raised important questions which need to be assessed by a Data Safety and Monitoring Board (DSMB). Since there are no documented harmful effects of the intervention, a DSMB was not appointed before initiation of the trial. The study was suspended on Aug 18th 2023.
A DSMB will be appointed, analyze the interim analyses, collect necessary additional information and make a recommendation to the PI whether the study is may proceed or is to be terminated prematurely.
Update September 2023.
The DSMB has reviewed the interim analyses and additional study data. The DSMB concluded that there was no reason to terminate the study and have recommended for the study to proceed. Recruitment was re-initiated on September 5th 2023.
Update November 2024.
The study has recruited 68/80 participants. We anticipate that remaining participants will be recruited by June 2025.
- Being tested
- Carbon dioxide flooding
- Keywords
- Aorta, Dissection, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide floodingProcedure or surgery
Once the thoracic cavity is opened a flow of carbon dioxide of 5L/min will be initiated into the surgical wound and proceed until there is no connection between the cardiac or aortic cavity and surrounding air.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Once the thoracic cavity os opened during surgery, carbon dioxide flooding using a diffusor will be instigated with a flow of 5L/min. The flooding will be terminated once the aorta and the heart have no open contact with surrounding air. Receives: Procedure: Carbon dioxide flooding |
| Control | No intervention | No intervention. No sham will be used as the staff performing the surgery would have been able to detect the lack of carbon dioxide in the surgical wound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ischemic lesions on magnetic resonance imaging (MRI)
Number of ischemic lesions visualized using MRI
Measured: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Size of ischemic lesions on magnetic resonance imaging (MRI)
Size of ischemic lesions visualized using MRI
Measured: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Secondary outcomes (26)
Clinical neurological injury
Clinical neurological injury (Coma according to clinical neurological assessment and/or clinical focal neurological injuries assessed by neurologist or verified ischemic lesions on MRI).
Measured: Up to postoperative day 7.
Neurological function
Patients will be assessed using the National Institute of Health Stroke Scale (NIHSS). Minimum score 0 points, maximum score 42 points, with 42 points being the worst outcome.
Measured: Postoperative day 4 or at discharge from the ICU.
Neurological function
Patients will be assessed using the modified Rankin Scale (mRS). Minimum score 0 points, maximum score 6 points, with 6 points being the worst outcome.
Measured: Postoperative day 4 or at discharge from the ICU.
Level of consciousness
Patients will be assessed using the Glasgow Coma Scale Motor Score. Minimum score 1 points, maximum score 6 points, with 6 points being the best outcome.
Measured: Postoperative day 4 or at discharge from the ICU.
Levels of S100B.
Concentration of S100B at predefined time points.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NSE.
Concentration of NSE at predefined time points.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NFL.
Concentration of NFL at predefined time points.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of GFAP.
Concentration of GFAP at predefined time points.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of UCH-L1.
Concentration of UCH-L1 at predefined time points.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of TAU.
Concentration of TAU at predefined time points.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Neurological function after ATAAD surgery.
Patients will be assessed using the National Institute of Health Stroke Scale (NIHSS) three months after surgery. Minimum score 0 points, maximum score 42 points, with 42 points being the worst outcome.
Measured: 3 months after surgery.
Neurological function after ATAAD surgery.
Patients will be assessed using the modified Rankin Scale (mRS). Minimum score 0 points, maximum score 6 points, with 6 points being the best outcome.
Measured: 3 months after surgery.
Neurocognitive function after ATAAD surgery.
Patients will be assessed using the Symbol digit modalities test (SDMT). Minimum score 0 points, maximum score 110 points, with 110 points being the best outcome.
Measured: 3 months after surgery.
Cognitive function after ATAAD surgery.
Patients will be assessed using the Montereal cognitive assesment (MoCA) test. Minimum score 0 points, maximum score 30 points, with 30 points being the best outcome.
Measured: 3 months after surgery.
Neurological recovery after ATAAD surgery.
Patients will be assessed using the 2 simple questions for stroke). Minimum score 0 points, maximum score 2 points, with 2 points being the worst outcome.
Measured: 3 months after surgery.
Postoperative recovery after ATAAD surgery.
Patients will be assessed using the Postoperative recovery profile. Minimum score 19 points, maximum score 76 points, with 76 points being the best outcome.
Measured: 3 months after surgery.
Quality of life after ATAAD surgery.
Patients will be assessed using the Satisfaction with life scale. Minimum score 0 points, maximum score 35 points, with 35 points being the best outcome.
Measured: 3 months after surgery.
Quality of life after ATAAD surgery.
Patients will be assessed using the EuroQol 5 dimensions 5 levels (EQ-5D-5L). Minimum score 5 points, maximum score 25 points, with 5 points being the best outcome.
Measured: 3 months after surgery.
Number of ischemic lesions on magnetic resonance imaging (MRI) in relation to the use of retrograde cerebral perfusion.
Number of ischemic lesions visualized using MRI analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Size of ischemic lesions on magnetic resonance imaging (MRI) in relation to the use of retrograde cerebral perfusion.
Size of ischemic lesions visualized using MRI analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Levels of S100B analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Concentration of S100B at predefined time points analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NSE analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Concentration of NSE at predefined time points analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NFL analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Concentration of NFL at predefined time points analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of GFAP analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Concentration of GFAP at predefined time points analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of UCH-L1 analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Concentration of UCH-L1 at predefined time points analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of TAU analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Concentration of TAU at predefined time points analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Measured: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for D000784Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, patient- and reviewer blinded interventional study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Zindovic, MD. PhD, Principal investigator, Region Skåne, Skåne university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962646
- Sponsor's protocol ID
- 2021-02039
- Acronym
- CARTA
- Status last verified
- Apr 2025
- First submitted
- 9 Jun 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ede J, Teurneau-Hermansson K, Moseby-Knappe M, Ramgren B, Bjursten H, Ederoth P, Larsson M, Mattsson-Carlgren N, Sjogren J, Wierup P, Nozohoor S, Zindovic I. Carbon dioxide flooding to reduce postoperative neurological injury following surgery for acute type A aortic dissection: a prospective, randomised, blinded, controlled clinical trial, CARTA study protocol - objectives and design. BMJ Open. 2023 May 25;13(5):e063837. doi: 10.1136/bmjopen-2022-063837.
PubMed 37230515
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARbon Dioxide Flooding to Reduce Postoperative Neurological Injury Following Surgery for Acute Type A Aortic Dissection - A Prospective, Randomized, Blinded, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04962646
- Acronym / sponsor ID
- CARTA / 2021-02039
- Keywords
- Aorta, Dissection, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Jul 2021 (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.
Aortic dissection is a life-threatening condition and a consequence of a tear of the innermost of the three aortic layers- the intima. When a tear occurs, blood surges through the tear and causes the flow of blood between the aortic layers, causing a "false lumen". This causes a weakening of the aortic wall and hinders the blood from reaching its target organs and life saving emergent surgery is performed as routine.
Approximately 20% of patients undergoing acute type a aortic dissection (ATAAD) surgery suffer from postoperative neurological injuries and It has been demonstrated that neurological injuries account for 10-15% of in-hospital deaths.
In association with other cardiac procedures where the left side of the heart is opened and air may be trapped within the arterial circulation, carbon dioxide flooding is used to displace open air from the surgical wound. In comparison to air, carbon dioxide is significantly more soluble in blood and may therefore decrease the risk of air embolism. In cardiac surgery, carbon dioxide flooding has been demonstrated to reduce levels of biomarkers of cerebral injury, but carbon dioxide is not routinely employed in ATAAD surgery and has not been studied in association with these procedures.
The hypothesis is that carbon dioxide flooding reduces cerebral air embolism and the aim of this project is to evaluate whether carbon dioxide flooding may reduce neurological injuries following ATAAD surgery.
This is a prospective, randomized, controlled, patient- and reviewer blinded interventional study. Patients will be randomized to undergo surgery with carbon-dioxide flooding at 5L/min to the open chest cavity or conventional surgery without carbon dioxide flooding. Remaining aspects of the procedure will be identical.
The patient, external statistician and the reviewer analyzing the primary endpoints will be blinded for the randomization arms.
The study will assess the following endpoints:
Primary outcomes: Presence, number and volume of ischaemic lesions observed using magnetic resonance imaging (MRI) after ATAAD surgery.
Secondary outcomes: Clinical signs of neurological injury. Levels of biomarkers of neurological injury (S100B, neuron specific enolase (NSE) , neurofilament protein (NFL), Glial fibrillary acid protein (GFAP) , Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and Tau-protein (TAU)) before and after surgery. Quality of life, postoperative recovery and neurological function after ATAAD surgery. Primary outcomes in relation to retrograde cerebral perfusion.
Start of inclusion is anticipated to start Jan 1st, 2022. The writing of a manuscript describing the study methods and study objectives is expected to be started in 2021 and the final manuscript is expected to be written during 2025.
An interim analysis of the primary endpoints and the safety arm will be performed after 40 patients have been randomized. An external statistician together with the principle investigator will hereafter decide for the study to be continued or terminated due to harms, futility or superiority.
The safety arm will include intraoperative mortality, in-hospital mortality, re-operation for bleeding, stroke, myocardial infarction or other thromboembolic events.
Update August 2023:
Interim analyses were performed after 40 study participants had been included. Results from the interim analyses raised important questions which need to be assessed by a Data Safety and Monitoring Board (DSMB). Since there are no documented harmful effects of the intervention, a DSMB was not appointed before initiation of the trial. The study was suspended on Aug 18th 2023.
A DSMB will be appointed, analyze the interim analyses, collect necessary additional information and make a recommendation to the PI whether the study is may proceed or is to be terminated prematurely.
Update September 2023.
The DSMB has reviewed the interim analyses and additional study data. The DSMB concluded that there was no reason to terminate the study and have recommended for the study to proceed. Recruitment was re-initiated on September 5th 2023.
Update November 2024.
The study has recruited 68/80 participants. We anticipate that remaining participants will be recruited by June 2025.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, patient- and reviewer blinded interventional study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Carbon dioxide floodingOnce the thoracic cavity os opened during surgery, carbon dioxide flooding using a diffusor will be instigated with a flow of 5L/min. The flooding will be terminated once the aorta and the heart have no open contact with surrounding air. |
| Control | No intervention | –No intervention. No sham will be used as the staff performing the surgery would have been able to detect the lack of carbon dioxide in the surgical wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Verified acute type A aortic dissection.
- Patient accepted for surgical repair.
Key exclusion criteria (5 listed)
- New-onset neurological symptoms defined as focal neurological symptoms or altered state of consciousness at time of inclusion.
- History of stroke with permanent neurological deficiency.
- Previous cardiac surgery.
- Surgery performed with cross clamping of the aorta without open distal anastomosis or open inspection of the distal aorta.
- Presence of implants or devices not compatible with Magnetic Resonance Imaging.
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 |
|---|---|---|
| Carbon dioxide floodingOnce the thoracic cavity is opened a flow of carbon dioxide of 5L/min will be initiated into the surgical wound and proceed until there is no connection between the cardiac or aortic cavity and surrounding air. | Procedure or surgery | Intervention |
Primary outcome
Number of ischemic lesions on magnetic resonance imaging (MRI)
Time frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Number of ischemic lesions visualized using MRI
Size of ischemic lesions on magnetic resonance imaging (MRI)
Time frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Size of ischemic lesions visualized using MRI
26 secondary outcomes
Clinical neurological injury
Time frame: Up to postoperative day 7.
Neurological function
Time frame: Postoperative day 4 or at discharge from the ICU.
Neurological function
Time frame: Postoperative day 4 or at discharge from the ICU.
Level of consciousness
Time frame: Postoperative day 4 or at discharge from the ICU.
Levels of S100B.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NSE.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NFL.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of GFAP.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of UCH-L1.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of TAU.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Neurological function after ATAAD surgery.
Time frame: 3 months after surgery.
Neurological function after ATAAD surgery.
Time frame: 3 months after surgery.
Neurocognitive function after ATAAD surgery.
Time frame: 3 months after surgery.
Cognitive function after ATAAD surgery.
Time frame: 3 months after surgery.
Neurological recovery after ATAAD surgery.
Time frame: 3 months after surgery.
Postoperative recovery after ATAAD surgery.
Time frame: 3 months after surgery.
Quality of life after ATAAD surgery.
Time frame: 3 months after surgery.
Quality of life after ATAAD surgery.
Time frame: 3 months after surgery.
Number of ischemic lesions on magnetic resonance imaging (MRI) in relation to the use of retrograde cerebral perfusion.
Time frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Size of ischemic lesions on magnetic resonance imaging (MRI) in relation to the use of retrograde cerebral perfusion.
Time frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.
Levels of S100B analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NSE analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of NFL analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of GFAP analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of UCH-L1 analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Levels of TAU analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.
Time frame: Preoperatively, 24 hours from start of surgery, postoperative day 4 and 3 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 37230515Ede J, Teurneau-Hermansson K, Moseby-Knappe M, Ramgren B, Bjursten H, Ederoth P, Larsson M, Mattsson-Carlgren N, Sjogren J, Wierup P, Nozohoor S, Zindovic I. Carbon dioxide flooding to reduce postoperative neurological injury following surgery for acute type A aortic dissection: a prospective, randomised, blinded, controlled clinical trial, CARTA study protocol - objectives and design. BMJ Open. 2023 May 25;13(5):e063837. doi: 10.1136/bmjopen-2022-063837.
- Individual participant dataSharing planned: No
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.
Igor Zindovic, MD. PhD principal investigator
Region Skåne, Skåne university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide flooding in people with D000784 and D020521, run by Region Skane at 1 site in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Zindovic, MD, PhD (+4646175288, igor.zindovic@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ischemic lesions on magnetic resonance imaging (MRI) (time frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.). The study lists 2 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 NCT04962646, which also lists 1 linked publication.
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 11 Apr 2025.