Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001583134
Ethics application status
Approved
Date submitted
27/07/2019
Date registered
18/11/2019
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results provided
18/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is more aggressive resection of the aorta for ascending aortic aneurysm safe and effective when compared to a less aggresive surgical approach?
Scientific title
Major adverse events rate after non-Hemiarch compared to hemiarch repair in ascending aortic aneurysm
Secondary ID [1] 298857 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ascending aortic aneurysm 313814 0
Condition category
Condition code
Surgery 312222 312222 0 0
Surgical techniques
Cardiovascular 312542 312542 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
One hundred and fifty-one patients underwent elective ascending aortic replacement only for nonsyndromic aneurismal disease between January 2008 to December 2018 were retrospectively reviewed. All data were prospectively collected and recorded. All surgeries were performed concurrently in the same time period. Surgeons who performed these operations were experienced with both circulatory arrest and clamped aortic anastomoses The decision to perform an ascending aortic replacement or a hemiarch replacement was at the discretion of the surgeon.

Description of the procedures:
Surgical access was obtained through a median sternotomy. Hemiarch repair was conducted under 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. Perfusion adequacy was evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy. Once CPB was instituted, the aortic cross-clamp was applied, and the heart was arrested with antegrade cardioplegia. After gradual cooling and when rectal temperature was approximately 28 degrees C, the circulatory arrest was initiated. Hemiarch replacement involved 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 was performed under normothermia with an aortic cross-clamp at the base of the innominate artery.

Audit of nurse notes (arterial pressure in both radial arteries, NIRS, body temperature), perfusion records (perfusion rate and perfusion pressure during both of cardiopulmonary bypass and unilateral cerebral perfusion in Hemiarch procedure, blood temperature, haemohydrobalance), blood tests (acid-base indices, total and biochemical blood tests) were performed to assess or monitor fidelity to the surgery.

Mean duration of non-hemiarch and hemiarch repairs surgery is 300 and 370 min, respectively. Mean duration of the circulatory arrest and antegrade cerebral perfusion in the hemiarch group was 15 minutes.

Follow-up information was collected using direct or phone contact with patients, relatives, or physicians. All survived patients underwent a clinical follow-up examination and aortic evaluation by CT scan before discharge, at 6 and 12 months postoperatively, and annually thereafter. The median (1st–3rd quartile) duration of the follow-up period was 36 months (12–48 months). The follow-up time was calculated using the date of the most recent CT scan
Intervention code [1] 315124 0
Not applicable
Comparator / control treatment
The total patient population (n=151) was divided into 2 groups of patients. The first group of the patients (n=40) underwent ascending aortic replacement with a distal cross-clamp (control group). The second group of the patients (n=111) underwent hemiarch repair using open distal aortic anastomosis (main group).
Control group
Active

Outcomes
Primary outcome [1] 320867 0
Operative mortality as assessed by data linkage to medical records
Timepoint [1] 320867 0
During the first 30 days after the procedure
Primary outcome [2] 321190 0
all-cause mortality as assessed by data linkage to medical records or or phone contact with relatives or physicians
Timepoint [2] 321190 0
Up to 5 years
Secondary outcome [1] 373119 0
incidence of the myocardial infarction was assessed by complex evaluation based on the ECG and echocardiographic changes as well as increase of the troponine level using serum assay
Timepoint [1] 373119 0
During the first 30 days after the procedure
Secondary outcome [2] 374254 0
Permament neurological deficit was defined as stroke, coma, or any new focal neurologic deficit that persisted >48 hours, accompanied by computed tomography or magnetic resonance imaging findings confirming a new brain injury
Timepoint [2] 374254 0
During the first 30 days after the procedure
Secondary outcome [3] 374255 0
New onset of the renal insufficiency (acute renal failure) requiring haemodialysis during ICU stay of the patient. An increase in the serum creatinine to >3.0 mg/dL and/or a >2-fold increase in the most recent preoperative creatinine level were indications for haemodyalisis.
Timepoint [3] 374255 0
during the first 30 days after the procedure
Secondary outcome [4] 374256 0
Respiratory failure (artificial ventilation for more than 72 hours) requiring tracheostomy during ICU stay of the patient as assesed by data linkage to medical records
Timepoint [4] 374256 0
During the first 30 days after the procedure

Eligibility
Key inclusion criteria
Patients with nonsyndromic ascending aortic aneuysm
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Oncological disease (high degrees)
Refusal of surgical treatment

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
All statistical analyses were performed using R 1.0.136, (RStudio, Inc., USA). Categorical variables are summarized as n (%). Continuous data that follow a Gaussian distribution are described as mean ± standard deviation. Continuous data that follow a non-Gaussian distribution are described as a sample median with the respective 25th and 75th percentiles. Baseline characteristics are compared using t tests for continuous variables and chi-square tests for categorical variables (Fisher’s exact tests when necessary due to small cell sizes). Immediate perioperative and postoperative outcomes are also compared using t tests for continuous variables and Fisher’s exact tests for categorical variables. Survival and freedom from re-intervention for each group is presented using Kaplan-Meier curves. Statistical differences in the survival distributions were assessed using the log-rank test. Due to baseline differences between treatment groups, we also performed a propensity score–matched analysis. Between-group comparisons were repeated in the propensity-matched population to ensure adequate balance in risk profile, and outcomes are then summarized in the matched population.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2008
Date of last participant enrolment
Anticipated
Actual
12/12/2018
Date of last data collection
Anticipated
Actual
12/12/2018
Sample size
Target
151
Accrual to date
Final
151
Recruitment outside Australia
Country [1] 21718 0
Russian Federation
State/province [1] 21718 0
Tomsk region

Funding & Sponsors
Funding source category [1] 303405 0
Hospital
Name [1] 303405 0
Cardiology Research Institute, Tomsk National Research Medical Center
Country [1] 303405 0
Russian Federation
Primary sponsor type
Hospital
Name
Cardiology Research Institute, Tomsk National Research Medical Center
Address
634012, Kievskaya st, 111a, Tomsk, Russia
Country
Russian Federation
Secondary sponsor category [1] 303449 0
None
Name [1] 303449 0
Address [1] 303449 0
Country [1] 303449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303934 0
Committee on biomedical ethics of Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Science
Ethics committee address [1] 303934 0
Ethics committee country [1] 303934 0
Russian Federation
Date submitted for ethics approval [1] 303934 0
Approval date [1] 303934 0
15/01/2018
Ethics approval number [1] 303934 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95306 0
Dr Kozlov Boris
Address 95306 0
Cardiology Research Institute, Tomsk National Research Medical Center Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 95306 0
Russian Federation
Phone 95306 0
+7 3822 555 483
Fax 95306 0
+7 3822 555 483
Email 95306 0
[email protected]
Contact person for public queries
Name 95307 0
Panfilov Dmitriy
Address 95307 0
Cardiology Research Institute, Tomsk National Research Medical Center Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 95307 0
Russian Federation
Phone 95307 0
+7 3822 555 483
Fax 95307 0
+7 3822 555 483
Email 95307 0
[email protected]
Contact person for scientific queries
Name 95308 0
Panfilov Dmitriy
Address 95308 0
Cardiology Research Institute, Tomsk National Research Medical Center Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 95308 0
Russian Federation
Phone 95308 0
+7 3822 555 483
Fax 95308 0
+7 3822 555 483
Email 95308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data cannot be submitted under patient confidentiality laws


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.