NCT06870513

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

March 6, 2025

Last Update Submit

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)

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).

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).

Procedure: Retrograde Cerebral Perfusion via Superior Vena Cava

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.

Also known as: Antegrade Brain Perfusion
Antegrade cerebral perfusion (ACP)

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.

Also known as: Retrograde Brain Perfusion
Retrograde Cerebral Perfusion (RCP)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University.

Suez Canal, Ismailia Governorate, 41522, Egypt

Location

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: 33495130BACKGROUND
  • 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.

    PMID: 22903579BACKGROUND
  • 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.

    PMID: 25168277BACKGROUND
  • 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.

    PMID: 33888364BACKGROUND
  • 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.

    PMID: 21747050BACKGROUND

Study Officials

  • Hany Anis Eldomiaty, Professor

    Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University, Suez, Egypt.

    STUDY CHAIR

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.

Locations