Comparative Study of Antegrade Versus Retrograde Cerebral Perfusion in Acute Type A Aortic Dissection: A Prospective Study
Comparative Study Between Antegrade and Retrograde Cerebral Perfusion in Acute or Subacute Aortic Dissection Type (A) Patients
1 other identifier
interventional
116
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedMay 30, 2025
May 1, 2025
2.5 years
March 6, 2025
May 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Postoperative assessment period (up to 30 days after surgery)
Secondary Outcomes (1)
Postoperative Mortality Rate
30 days post-surgery
Study Arms (2)
Antegrade cerebral perfusion (ACP)
EXPERIMENTALParticipants 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 COMPARATORParticipants 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \- Patients diagnosed with acute type A aortic dissection (TAAD).
You may not qualify if:
- Hemodynamic instability.
- Known ischemic heart disease (IHD).
- History of cerebrovascular stroke.
- Heart failure.
- Renal or hepatic impairment.
- Rheumatic heart disease.
- Previous history of radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yusuf Shiebalead
Study Sites (1)
Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University.
Suez Canal, Ismailia Governorate, 41522, Egypt
Related Publications (5)
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.
PMID: 33495130BACKGROUNDSugiura 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.
PMID: 22903579BACKGROUNDTokuda 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.
PMID: 25168277BACKGROUNDSun 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.
PMID: 33888364BACKGROUNDKruger 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.
PMID: 21747050BACKGROUND
Study Officials
- STUDY CHAIR
Hany Anis Eldomiaty, Professor
Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University, Suez, Egypt.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
March 6, 2025
First Posted
March 11, 2025
Study Start
June 22, 2020
Primary Completion
January 1, 2023
Study Completion
March 1, 2023
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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.