Acute Type A Aortic DissectionNCT06870513
Comparative Study of Antegrade Versus Retrograde Cerebral Perfusion in Acute Type A Aortic Dissection: A Prospective Study
A study testing Antegrade Cerebral Perfusion via Axillary Artery and Retrograde Cerebral Perfusion via Superior Vena Cava in people with Acute Type A Aortic Dissection, run by Yusuf Shieba at 1 site in Egypt.
Trial summary
This prospective study investigated the comparison of effectiveness of antegrade cerebral perfusion (ACP) and retrograde cerebral perfusion (RCP) in providing cerebral protection during the surgical treatment of acute Type A aortic dissection (TAAD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Type A Aortic Dissection
- What is being tested?
- Antegrade Cerebral Perfusion via Axillary Artery and Retrograde Cerebral Perfusion via Superior Vena Cava
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2020to 1 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with acute type A aortic dissection (TAAD).
Who cannot join
- Hemodynamic instability.
- Known ischemic heart disease (IHD).
- History of cerebrovascular stroke.
- Heart failure.
- Renal or hepatic impairment.
- Rheumatic heart disease.
- Previous history of radiotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University.
Suez Canal, Ismailia Governorate, 41522
About this study
Official title: Comparative Study Between Antegrade and Retrograde Cerebral Perfusion in Acute or Subacute Aortic Dissection Type (A) Patients
This prospective study investigated the comparison of effectiveness of antegrade cerebral perfusion (ACP) and retrograde cerebral perfusion (RCP) in providing cerebral protection during the surgical treatment of acute Type A aortic dissection (TAAD). Acute type A aortic dissection presents an aortic tear at its ascending portion, posing considerable risk with high morbidity and mortality incidence, especially from neurological insults.
In total, 116 patients with acute type A aortic dissection were randomly assigned to undergo surgical intervention with either ACP through axillary artery cannulation or RCP through superior vena cava cannula placed during deep hypothermic circulatory arrest. Primary objectives focused on measuring and comparing the postoperative neurological complication rates associated with transient neurological deficits (TND) and permanent neurological deficits (PND). Secondary outcomes of interest included the duration of mechanical ventilation, length of stay in the ICU and hospital, and mortality.
- Conditions
- Acute Type A Aortic Dissection
- Being tested
- Antegrade Cerebral Perfusion via Axillary Artery, Retrograde Cerebral Perfusion via Superior Vena Cava
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade Cerebral Perfusion via Axillary ArteryProcedure or surgery
Also called Antegrade Brain Perfusion
In antegrade cerebral perfusion (ACP), patients underwent cannulation of the right axillary artery using an interposition Dacron graft (7 mm) connected to a cardiopulmonary bypass (CPB) circuit. During surgery, ACP delivered oxygenated blood flow directly into the brain arteries to maintain cerebral protection during the period of deep hypothermic circulatory arrest (DHCA), enabling the surgical team to perform the distal aortic anastomosis safely.
Retrograde Cerebral Perfusion via Superior Vena CavaProcedure or surgery
Also called Retrograde Brain Perfusion
In retrograde cerebral perfusion (RCP), cannulation of the superior vena cava (SVC) was performed to deliver blood flow in reverse direction during deep hypothermic circulatory arrest (DHCA). This method aimed to provide cerebral protection by supporting cerebral metabolism during the surgical repair of acute Type A aortic dissection.
| Study group | Role | What they receive |
|---|---|---|
| Antegrade cerebral perfusion (ACP) | Experimental | Participants underwent surgical repair of acute Type A aortic dissection utilizing antegrade cerebral perfusion. The procedure involved right axillary artery cannulation through an interposition conduit graft (7-mm Dacron tube) for cardiopulmonary bypass and cerebral perfusion during deep hypothermic circulatory arrest (DHCA). Receives: Procedure: Antegrade Cerebral Perfusion via Axillary Artery |
| Retrograde Cerebral Perfusion (RCP) | Active comparator | Participants in this arm underwent surgical repair of acute Type A aortic dissection utilizing retrograde cerebral perfusion (RCP). Perfusion was provided retrogradely via superior vena cava (SVC) cannulation during deep hypothermic circulatory arrest (DHCA). Receives: Procedure: Retrograde Cerebral Perfusion via Superior Vena Cava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Neurological Complications (Transient and Permanent Neurological Deficits)
Comparison of the incidence of neurological complications, including transient neurological deficits (temporary postoperative mental status changes or neurological dysfunction resolving within 24 hours) and permanent neurological deficits (lasting neurological impairments such as stroke, paralysis, coma, or death).
Measured: Postoperative assessment period (up to 30 days after surgery)
Secondary outcomes (1)
Postoperative Mortality Rate
Comparison of mortality rates within 30 days following surgical intervention between the two perfusion groups (ACP vs. RCP).
Measured: 30 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 posted11 Mar 2025
- Study start22 Jun 2020
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Type A Aortic DissectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yusuf Shieba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yusuf Shieba, South Valley University
- Investigators
- Hany Anis Eldomiaty, Professor, Study chair, Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University, Suez, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870513
- Sponsor's protocol ID
- SCU-FOM-CTS-2020-4222
- Status last verified
- May 2025
- First submitted
- 6 Mar 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to publicly share individual participant data (IPD). Data sharing was not included in the informed consent, and privacy regulations restrict the sharing of individual-level data.
Publications
Samanidis G, Kanakis M, Khoury M, Balanika M, Antoniou T, Giannopoulos N, Stavridis G, Perreas K. Antegrade and Retrograde Cerebral Perfusion During Acute Type A Aortic Dissection Repair in 290 Patients. Heart Lung Circ. 2021 Jul;30(7):1075-1083. doi: 10.1016/j.hlc.2020.12.007. Epub 2021 Jan 22.
PubMed 33495130Sugiura T, Imoto K, Uchida K, Minami T, Yasuda S. Comparative study of brain protection in ascending aorta replacement for acute type A aortic dissection: retrograde cerebral perfusion versus selective antegrade cerebral perfusion. Gen Thorac Cardiovasc Surg. 2012 Oct;60(10):645-8. doi: 10.1007/s11748-012-0142-z. Epub 2012 Aug 18.
PubMed 22903579Tokuda Y, Miyata H, Motomura N, Oshima H, Usui A, Takamoto S; Japan Adult Cardiovascular Database Organization. Brain protection during ascending aortic repair for Stanford type A acute aortic dissection surgery. Nationwide analysis in Japan. Circ J. 2014;78(10):2431-8. doi: 10.1253/circj.cj-14-0565. Epub 2014 Aug 28.
PubMed 25168277Sun S, Chien CY, Fan YF, Wu SJ, Li JY, Tan YH, Hsu KH. Retrograde cerebral perfusion for surgery of type A aortic dissection. Asian J Surg. 2021 Dec;44(12):1529-1534. doi: 10.1016/j.asjsur.2021.03.047. Epub 2021 Apr 20.
PubMed 33888364Kruger T, Weigang E, Hoffmann I, Blettner M, Aebert H; GERAADA Investigators. Cerebral protection during surgery for acute aortic dissection type A: results of the German Registry for Acute Aortic Dissection Type A (GERAADA). Circulation. 2011 Jul 26;124(4):434-43. doi: 10.1161/CIRCULATIONAHA.110.009282. Epub 2011 Jul 11.
PubMed 21747050
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Antegrade and Retrograde Cerebral Perfusion in Acute or Subacute Aortic Dissection Type (A) Patients
- ClinicalTrials.gov ID
- NCT06870513
- Acronym / sponsor ID
- SCU-FOM-CTS-2020-4222
- Conditions
- Acute Type A Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Yusuf ShiebaUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Mar 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 prospective study investigated the comparison of effectiveness of antegrade cerebral perfusion (ACP) and retrograde cerebral perfusion (RCP) in providing cerebral protection during the surgical treatment of acute Type A aortic dissection (TAAD). Acute type A aortic dissection presents an aortic tear at its ascending portion, posing considerable risk with high morbidity and mortality incidence, especially from neurological insults.
In total, 116 patients with acute type A aortic dissection were randomly assigned to undergo surgical intervention with either ACP through axillary artery cannulation or RCP through superior vena cava cannula placed during deep hypothermic circulatory arrest. Primary objectives focused on measuring and comparing the postoperative neurological complication rates associated with transient neurological deficits (TND) and permanent neurological deficits (PND). Secondary outcomes of interest included the duration of mechanical ventilation, length of stay in the ICU and hospital, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antegrade cerebral perfusion (ACP) | Experimental | Procedure: Antegrade Cerebral Perfusion via Axillary ArteryParticipants underwent surgical repair of acute Type A aortic dissection utilizing antegrade cerebral perfusion. The procedure involved right axillary artery cannulation through an interposition conduit graft (7-mm Dacron tube) for cardiopulmonary bypass and cerebral perfusion during deep hypothermic circulatory arrest (DHCA). |
| Retrograde Cerebral Perfusion (RCP) | Active comparator | Procedure: Retrograde Cerebral Perfusion via Superior Vena CavaParticipants in this arm underwent surgical repair of acute Type A aortic dissection utilizing retrograde cerebral perfusion (RCP). Perfusion was provided retrogradely via superior vena cava (SVC) cannulation during deep hypothermic circulatory arrest (DHCA). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with acute type A aortic dissection (TAAD).
Key exclusion criteria (7 listed)
- Hemodynamic instability.
- Known ischemic heart disease (IHD).
- History of cerebrovascular stroke.
- Heart failure.
- Renal or hepatic impairment.
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 |
|---|---|---|
| Antegrade Cerebral Perfusion via Axillary ArteryAlso: Antegrade Brain PerfusionIn antegrade cerebral perfusion (ACP), patients underwent cannulation of the right axillary artery using an interposition Dacron graft (7 mm) connected to a cardiopulmonary bypass (CPB) circuit. During surgery, ACP delivered oxygenated blood flow directly into the brain arteries to maintain cerebral protection during the period of deep hypothermic circulatory arrest (DHCA), enabling the surgical team to perform the distal aortic anastomosis safely. | Procedure or surgery | Antegrade cerebral perfusion (ACP) |
| Retrograde Cerebral Perfusion via Superior Vena CavaAlso: Retrograde Brain PerfusionIn retrograde cerebral perfusion (RCP), cannulation of the superior vena cava (SVC) was performed to deliver blood flow in reverse direction during deep hypothermic circulatory arrest (DHCA). This method aimed to provide cerebral protection by supporting cerebral metabolism during the surgical repair of acute Type A aortic dissection. | Procedure or surgery | Retrograde Cerebral Perfusion (RCP) |
Primary outcome
Incidence of Neurological Complications (Transient and Permanent Neurological Deficits)
Time frame: Postoperative assessment period (up to 30 days after surgery)
Comparison of the incidence of neurological complications, including transient neurological deficits (temporary postoperative mental status changes or neurological dysfunction resolving within 24 hours) and permanent neurological deficits (lasting neurological impairments such as stroke, paralysis, coma, or death).
1 secondary outcome
Postoperative Mortality Rate
Time frame: 30 days post-surgery
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 30 May 2025.
- Background: PubMed 33495130Samanidis G, Kanakis M, Khoury M, Balanika M, Antoniou T, Giannopoulos N, Stavridis G, Perreas K. Antegrade and Retrograde Cerebral Perfusion During Acute Type A Aortic Dissection Repair in 290 Patients. Heart Lung Circ. 2021 Jul;30(7):1075-1083. doi: 10.1016/j.hlc.2020.12.007. Epub 2021 Jan 22.
- Background: PubMed 22903579Sugiura T, Imoto K, Uchida K, Minami T, Yasuda S. Comparative study of brain protection in ascending aorta replacement for acute type A aortic dissection: retrograde cerebral perfusion versus selective antegrade cerebral perfusion. Gen Thorac Cardiovasc Surg. 2012 Oct;60(10):645-8. doi: 10.1007/s11748-012-0142-z. Epub 2012 Aug 18.
- Background: PubMed 25168277Tokuda Y, Miyata H, Motomura N, Oshima H, Usui A, Takamoto S; Japan Adult Cardiovascular Database Organization. Brain protection during ascending aortic repair for Stanford type A acute aortic dissection surgery. Nationwide analysis in Japan. Circ J. 2014;78(10):2431-8. doi: 10.1253/circj.cj-14-0565. Epub 2014 Aug 28.
- Background: PubMed 33888364Sun S, Chien CY, Fan YF, Wu SJ, Li JY, Tan YH, Hsu KH. Retrograde cerebral perfusion for surgery of type A aortic dissection. Asian J Surg. 2021 Dec;44(12):1529-1534. doi: 10.1016/j.asjsur.2021.03.047. Epub 2021 Apr 20.
- Background: PubMed 21747050Kruger T, Weigang E, Hoffmann I, Blettner M, Aebert H; GERAADA Investigators. Cerebral protection during surgery for acute aortic dissection type A: results of the German Registry for Acute Aortic Dissection Type A (GERAADA). Circulation. 2011 Jul 26;124(4):434-43. doi: 10.1161/CIRCULATIONAHA.110.009282. Epub 2011 Jul 11.
- Individual participant dataSharing planned: No. At this time, there is no plan to publicly share individual participant data (IPD). Data sharing was not included in the informed consent, and privacy regulations restrict the sharing of individual-level data.
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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.
Hany Anis Eldomiaty, Professor study chair
Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University, Suez, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antegrade Cerebral Perfusion via Axillary Artery and Retrograde Cerebral Perfusion via Superior Vena Cava in people with Acute Type A Aortic Dissection, run by Yusuf Shieba at 1 site in Egypt.
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 7 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 30 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 Egypt. 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?
Incidence of Neurological Complications (Transient and Permanent Neurological Deficits) (time frame: Postoperative assessment period (up to 30 days after 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 NCT06870513, which also lists 5 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 30 May 2025.