Acute Type A Aortic DissectionNCT06943716
Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion in Acute Type A Aortic Dissection Surgery
An observational study of Acute Type A Aortic Dissection, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This retrospective cohort study aims to evaluate the efficacy of a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique in acute Type A aortic dissection surgery. Medical records from January 1, 2021, through October 31, 2024, at China Medical University Hospital will be reviewed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Type A Aortic Dissection
- What is being tested?
- Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) and Conventional Brain Perfusion
- Type of treatment
- Surgery or procedure
- How many people
- 273 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 11 Apr 2025
- 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 patients diagnosed with acute Type A aortic dissection who underwent surgical repair at China Medical University Hospital. The population includes individuals receiving either Modified bACP or conventional perfusion during the specified period.
Who may be able to join
- Adults (≥ 18 years old) who underwent acute Type A aortic dissection repair at China Medical University Hospital between January 1, 2021, and October 31, 2024.
Who cannot join
- Preexisting severe neurological impairment (e.g., stroke or other major neurological deficits before surgery).
- Age < 18 years.
- Pregnant patients.
- Insufficient or missing medical records preventing data analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Cohort Study Evaluating the Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) in Acute Type A Aortic Dissection Surgery
This retrospective cohort study aims to evaluate the efficacy of a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique in acute Type A aortic dissection surgery. Medical records from January 1, 2021, through October 31, 2024, at China Medical University Hospital will be reviewed. The primary outcomes include in-hospital mortality and stroke rate, while secondary outcomes include ICU/hospital stay, mechanical ventilation duration, and other postoperative complications (e.g., acute kidney injury, sepsis, myocardial infarction).
Read the detailed description
Background and Rationale Acute Type A aortic dissection (ATAAD) is a life-threatening condition requiring urgent surgical repair. Prolonged circulatory arrest increases the risk of neurological complications. Bilateral antegrade cerebral perfusion (bACP) has shown potential to reduce ischemic injury. However, conventional bACP requires additional surgical access. This study examines a Modified bACP approach that may reduce surgical trauma while maintaining adequate cerebral perfusion.
Objectives This retrospective cohort study evaluates whether Modified bACP improves postoperative outcomes compared to conventional perfusion strategies in ATAAD surgery at China Medical University Hospital (2021/1/1-2024/10/31).
Methods We will collect and analyze medical records of adult patients who underwent ATAAD repair, comparing those who received Modified bACP to those managed with conventional perfusion.
Outcome Measures
Primary Outcomes:
In-hospital mortality 30-day mortality
Secondary Outcomes:
Hospital length of stay (day) ICU length of stay (day) Mechanical ventilation duration (hours) Need for tracheostomy Stroke Postoperative neurological deficit Paraplegia Coma Atrial fibrillation (Af) Myocardial infarction Acute kidney injury (AKI) Dialysis requirement Reoperation for bleeding Sepsis Significance This study aims to provide comprehensive data on the safety and efficacy of Modified bACP in ATAAD surgery, potentially improving neurological protection and reducing other major complications and resource utilization. The findings may guide clinical practice and inform future protocol developments.
- Conditions
- Acute Type A Aortic Dissection
- Being tested
- Modified Catheter Antegrade Cerebral Perfusion (Modified bACP), Conventional Brain Perfusion
- Keywords
- Bilateral Catheter Antegrade Cerebral Perfusion, Acute Type A Aortic Dissection, Neurological Complications, Modified bACP, Retrospective Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)Procedure or surgery
A modified bilateral catheter antegrade cerebral perfusion technique used for acute Type A aortic dissection repair. This approach aims to reduce surgical trauma by avoiding additional right axillary access while maintaining stable cerebral perfusion.
Conventional Brain PerfusionProcedure or surgery
Patients receiving the conventional perfusion strategy for aortic arch surgery, which may include standard bilateral ACP based on the surgeon's preference and the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| Modified bACP Group | Patients who underwent acute Type A aortic dissection repair using the Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique. This observational group received the modified perfusion strategy aimed at reducing surgical trauma and enhancing cerebral protection. Receives: Procedure: Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) | |
| Conventional Perfusion Group | Patients who underwent acute Type A aortic dissection repair using the conventional brain perfusion technique (e.g., standard bilateral antegrade cerebral perfusion). This group serves as the comparison cohort for evaluating the effects of the modified technique. Receives: Procedure: Conventional Brain Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
New-onset cerebrovascular accident or imaging-confirmed stroke during hospitalization.
Measured: Through hospital discharge (on average about 14 days post-surgery)
Secondary outcomes (11)
Postoperative Neurological Deficit
Any persistent neurological deficit (e.g., motor/sensory deficits) identified after surgery.
Measured: Through hospital discharge (on average about 14 days post-surgery)
30-day Mortality
All-cause mortality occurring within 30 days after the surgical procedure.
Measured: Assessed at 30 days post-surgery
Hospital Stay (day)
Total number of days from the operation date to the date of hospital discharge.
Measured: From end of surgery to hospital discharge (up to 21 days).
ICU Stay (day)
Length of stay in the intensive care unit after surgery.
Measured: From end of surgery to ICU discharge (up to 10 days).
Mechanical Ventilation (hour)
Duration of mechanical ventilation in hours.
Measured: From end of surgery until extubation (up to 72 hours).
Acute Kidney Injury (AKI)
Acute kidney injury defined by changes in serum creatinine or urine output (e.g., KDIGO criteria).
Measured: During the index hospitalization (on average about 10-14 days post-surgery)
Dialysis Requirement
Proportion of patients requiring renal replacement therapy (dialysis) postoperatively.
Measured: During the index hospitalization (on average about 10-14 days post-surgery)
Reoperation for Bleeding
Number of patients requiring a return to the operating room for bleeding control or hematoma.
Measured: During the index hospitalization (on average about 72 hours post-surgery)
Sepsis
Incidence of sepsis as defined by current guidelines (e.g., Sepsis-3), typically requiring positive cultures and organ dysfunction.
Measured: During the index hospitalization (on average within 7 days post-surgery)
Atrial Fibrillation (Af)
New-onset atrial fibrillation or documented arrhythmia episodes requiring clinical management.
Measured: During the index hospitalization (on average within 7 days post-surgery)
Myocardial Infarction
Clinically confirmed myocardial infarction based on ECG changes, cardiac enzymes, and clinical symptoms.
Measured: During the index hospitalization (on average about 10-14 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jan 2021
- Primary completion31 Oct 2024
- Study completion11 Apr 2025
Why it stopped: Terminated due to insufficient enrollment to achieve desired statistical power. A new IRB approval will be sought to extend the retrospective data collection period.
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 Acute Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- En-Bo Wu, M.D., Principal investigator, Department of Anesthesiology, China Medical University Hospital, China Medical University, Taichung City 404, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943716
- Sponsor's protocol ID
- CMUH113-REC1-183
- Other IDs
- CMUH113-REC1-183
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to institutional privacy policies and IRB regulations that restrict the release of patient-level data. The de-identified data are only approved for internal use by the research team and cannot be disclosed to external parties without additional ethics approval.
Publications
Pitts L, Kofler M, Montagner M, Heck R, Iske J, Buz S, Kurz SD, Starck C, Falk V, Kempfert J. Cerebral Protection Strategies and Stroke in Surgery for Acute Type A Aortic Dissection. J Clin Med. 2023 Mar 15;12(6):2271. doi: 10.3390/jcm12062271.
PubMed 36983272
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study Evaluating the Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) in Acute Type A Aortic Dissection Surgery
- ClinicalTrials.gov ID
- NCT06943716
- Acronym / sponsor ID
- CMUH113-REC1-183
- Conditions
- Acute Type A Aortic Dissection
- Keywords
- Bilateral Catheter Antegrade Cerebral Perfusion, Acute Type A Aortic Dissection, Neurological Complications, Modified bACP, Retrospective Cohort
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to insufficient enrollment to achieve desired statistical power. A new IRB approval will be sought to extend the retrospective data collection period.
- Enrolment
- 273 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 24 Apr 2025 (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.
This retrospective cohort study aims to evaluate the efficacy of a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique in acute Type A aortic dissection surgery. Medical records from January 1, 2021, through October 31, 2024, at China Medical University Hospital will be reviewed. The primary outcomes include in-hospital mortality and stroke rate, while secondary outcomes include ICU/hospital stay, mechanical ventilation duration, and other postoperative complications (e.g., acute kidney injury, sepsis, myocardial infarction).
Detailed description
Background and Rationale Acute Type A aortic dissection (ATAAD) is a life-threatening condition requiring urgent surgical repair. Prolonged circulatory arrest increases the risk of neurological complications. Bilateral antegrade cerebral perfusion (bACP) has shown potential to reduce ischemic injury. However, conventional bACP requires additional surgical access. This study examines a Modified bACP approach that may reduce surgical trauma while maintaining adequate cerebral perfusion.
Objectives This retrospective cohort study evaluates whether Modified bACP improves postoperative outcomes compared to conventional perfusion strategies in ATAAD surgery at China Medical University Hospital (2021/1/1-2024/10/31).
Methods We will collect and analyze medical records of adult patients who underwent ATAAD repair, comparing those who received Modified bACP to those managed with conventional perfusion.
Outcome Measures
Primary Outcomes:
In-hospital mortality 30-day mortality
Secondary Outcomes:
Hospital length of stay (day) ICU length of stay (day) Mechanical ventilation duration (hours) Need for tracheostomy Stroke Postoperative neurological deficit Paraplegia Coma Atrial fibrillation (Af) Myocardial infarction Acute kidney injury (AKI) Dialysis requirement Reoperation for bleeding Sepsis Significance This study aims to provide comprehensive data on the safety and efficacy of Modified bACP in ATAAD surgery, potentially improving neurological protection and reducing other major complications and resource utilization. The findings may guide clinical practice and inform future protocol developments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified bACP Group | – | Procedure: Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)Patients who underwent acute Type A aortic dissection repair using the Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique. This observational group received the modified perfusion strategy aimed at reducing surgical trauma and enhancing cerebral protection. |
| Conventional Perfusion Group | – | Procedure: Conventional Brain PerfusionPatients who underwent acute Type A aortic dissection repair using the conventional brain perfusion technique (e.g., standard bilateral antegrade cerebral perfusion). This group serves as the comparison cohort for evaluating the effects of the modified technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with acute Type A aortic dissection who underwent surgical repair at China Medical University Hospital. The population includes individuals receiving either Modified bACP or conventional perfusion during the specified period.
Key inclusion criteria (1 listed)
- Adults (≥ 18 years old) who underwent acute Type A aortic dissection repair at China Medical University Hospital between January 1, 2021, and October 31, 2024.
Key exclusion criteria (4 listed)
- Preexisting severe neurological impairment (e.g., stroke or other major neurological deficits before surgery).
- Age < 18 years.
- Pregnant patients.
- Insufficient or missing medical records preventing data analysis.
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 |
|---|---|---|
| Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)A modified bilateral catheter antegrade cerebral perfusion technique used for acute Type A aortic dissection repair. This approach aims to reduce surgical trauma by avoiding additional right axillary access while maintaining stable cerebral perfusion. | Procedure or surgery | Modified bACP Group |
| Conventional Brain PerfusionPatients receiving the conventional perfusion strategy for aortic arch surgery, which may include standard bilateral ACP based on the surgeon's preference and the patient's condition. | Procedure or surgery | Conventional Perfusion Group |
Primary outcome
Stroke
Time frame: Through hospital discharge (on average about 14 days post-surgery)
New-onset cerebrovascular accident or imaging-confirmed stroke during hospitalization.
11 secondary outcomes
Postoperative Neurological Deficit
Time frame: Through hospital discharge (on average about 14 days post-surgery)
30-day Mortality
Time frame: Assessed at 30 days post-surgery
Hospital Stay (day)
Time frame: From end of surgery to hospital discharge (up to 21 days).
ICU Stay (day)
Time frame: From end of surgery to ICU discharge (up to 10 days).
Mechanical Ventilation (hour)
Time frame: From end of surgery until extubation (up to 72 hours).
Acute Kidney Injury (AKI)
Time frame: During the index hospitalization (on average about 10-14 days post-surgery)
Dialysis Requirement
Time frame: During the index hospitalization (on average about 10-14 days post-surgery)
Reoperation for Bleeding
Time frame: During the index hospitalization (on average about 72 hours post-surgery)
Sepsis
Time frame: During the index hospitalization (on average within 7 days post-surgery)
Atrial Fibrillation (Af)
Time frame: During the index hospitalization (on average within 7 days post-surgery)
Myocardial Infarction
Time frame: During the index hospitalization (on average about 10-14 days post-surgery)
Results and safety
The study was stopped early (reason given: Terminated due to insufficient enrollment to achieve desired statistical power. A new IRB approval will be sought to extend the retrospective data collection period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Results publication: PubMed 36983272Pitts L, Kofler M, Montagner M, Heck R, Iske J, Buz S, Kurz SD, Starck C, Falk V, Kempfert J. Cerebral Protection Strategies and Stroke in Surgery for Acute Type A Aortic Dissection. J Clin Med. 2023 Mar 15;12(6):2271. doi: 10.3390/jcm12062271.
- Individual participant dataSharing planned: No. IPD will not be shared due to institutional privacy policies and IRB regulations that restrict the release of patient-level data. The de-identified data are only approved for internal use by the research team and cannot be disclosed to external parties without additional ethics approval.
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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.
En-Bo Wu, M.D. principal investigator
Department of Anesthesiology, China Medical University Hospital, China Medical University, Taichung City 404, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Type A Aortic Dissection, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 May 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 Taiwan. 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 was stopped early (reason given: Terminated due to insufficient enrollment to achieve desired statistical power. A new IRB approval will be sought to extend the retrospective data collection period.). Results are not available in the source record.
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?
Stroke (time frame: Through hospital discharge (on average about 14 days post-surgery)). 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 NCT06943716, 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 7 May 2025.