The Gender Specific Effect on the Results of Ascending Aortic Replacement

NCT04905225 | Completed

• 1 other identifier: Tomsk NRMC CRI
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to analyze the early and late results in men and women who underwent ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate hypothermic circulatory arrest. Female gender is associated with poorer outcomes after surgical aorta replacement. Data on gender specific differences after ascending aortic replacement are conflicting.

Conditions

Ascending Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Operative mortality

  Operative mortality (%) as assessed by data linkage to medical records Comparison of men vs women in aortic hemiarch surgery with respect to the incidence of death

  During the first 30 days after the procedure

• All-cause mortality

  all-cause mortality as assessed by data linkage to medical records or or phone contact with relatives or physicians

  Up to 5 years

Secondary Outcomes (6)

• Perioperative Myocardial Infarction

  During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. )

• Rates of re-exploration for bleeding

  During the first 3 days after the procedure

• Respiratory failure

  During the first 30 days after the procedure

• The duration of a patient's stay in the intensive care unit and on the hospital ward

  Up to 90 days after surgery

• Incidence of Acute Kidney Injury (AKI)

  During the first 30 days after the procedure

Study Arms (1)

Ascending aortic replacement

Ascending aortic replacement in ascending aortic aneurysm in men and women

Procedure: Ascending aortic replacement

Interventions

Ascending aortic replacement PROCEDURE

Surgical access will be performed through a median sternotomy. Ascending aortic repair is performed under conditions of cardiopulmonary bypass (CPB) and MHCA with unilateral ACP via innominate artery with a flow rate of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Once CPB is instituted, the aortic cross-clamp is applied, and the heart is arrested with antegrade cardioplegia. Hemiarch replacement involves resection lesser curve of the aortic arch from the base of the innominate artery (Zone 0) to a point immediately distal to the nadir of the lesser curvature (Zone 3 or Zone 2 if the left subclavian artery was too far).

Ascending aortic replacement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ascending aortic aneurysm with Hemiarch replacement

You may qualify if:

• Patients with small ascending aortic aneurysm (5.0-5.5 cm)
• Elective procedure
• Able to provide written informed consent

You may not qualify if:

• Surgery for acute aortic dissection or emergent operations
• Refusal of surgical treatment
• Oncological disease (high degrees)
• Multiple organ failure

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk NRMC

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Aneurysm, Ascending Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Boris N Kozlov, Dr

  TOMSK NRMC CARDIOLOGY RESEARCH INSTITUTE

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 27, 2021
• Study Start: January 1, 2013
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

RU (1)