- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870513
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
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ismailia
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Suez Canal, Ismailia, Egypt, 41522
- Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Antegrade cerebral perfusion (ACP)
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).
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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.
Other Names:
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Active Comparator: Retrograde Cerebral Perfusion (RCP)
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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Neurological Complications (Transient and Permanent Neurological Deficits)
Time Frame: Postoperative assessment period (up to 30 days after surgery)
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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).
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Postoperative assessment period (up to 30 days after surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Mortality Rate
Time Frame: 30 days post-surgery
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Comparison of mortality rates within 30 days following surgical intervention between the two perfusion groups (ACP vs. RCP).
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30 days post-surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hany Anis Eldomiaty, Professor, Department of Cardiothoracic Surgery, Faculty of Medicine, Suez Canal University, Suez, Egypt.
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCU-FOM-CTS-2020-4222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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