Clinical trial NCT06870513: Comparative Study of Antegrade Versus Retrograde Cerebral Perfusion in Acute Type A Aortic Dissection: A Prospective Study
Official title: Comparative Study Between Antegrade and Retrograde Cerebral Perfusion in Acute or Subacute Aortic Dissection Type (A) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Type A Aortic Dissection
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

- Patients diagnosed with acute type A aortic dissection (TAAD).

Exclusion Criteria:

* Hemodynamic instability.
* Known ischemic heart disease (IHD).
* History of cerebrovascular stroke.
* Heart failure.
* Renal or hepatic impairment.
* Rheumatic heart disease.
* Previous history of radiotherapy.

Primary outcomes:
measure: Incidence of Neurological Complications (Transient and Permanent Neurological Deficits)
timeFrame: Postoperative assessment period (up to 30 days after surgery)
Secondary outcomes:
measure: Postoperative Mortality Rate
timeFrame: 30 days post-surgery
Other outcomes:
Locations:
city: Suez Canal
country: Egypt
facility: Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University.
state: Ismailia
Study officials:
affiliation: Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University, Suez, Egypt.
name: Hany Anis Eldomiaty, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Sugiura 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.
citation: Tokuda 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.
citation: Sun 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.
citation: Kruger 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.