Ascending Aorta Aneurism
Conditions
Keywords
Extracorporeal circulation, Deep Hypothermic Circulatory Arrest, aortic aneurism, neurological injury, inflammation, coagulation
Brief summary
PURPOSE: To compare crash cooling versus gradient cooling methods for patients undergoing planned surgery on the ascending aorta in deep hypothermic circulatory arrest. To investigate the impact of hypothermia and circulatory arrest on the coagulation, stress-response, and cerebral outcome. BACKGROUND: Cooling to 18 °C using extracorporeal circulation allows for circulatory arrest during surgery on the ascending aorta. Two different methods are used either lowering the temperature of the blood by 10 °C at a time, gradient cooling, or as cold as possible, crash cooling. The distribution of hypothermia is expected to be different for the two methods, the latter predominantly cooling the body core. The influence on the physiological response is expected to vary with the two methods. The surgical procedure and the cooling greatly elicit a stress response and the coagulation is profoundly influenced. There can be adverse effects on the neurological outcome due to the procedure. The two methods are considered equal, but have never been subjected to comparison. The surgery and circulatory changes can have a negative influence on the cerebral outcome . METHODS: Twenty patients between 18 and 80 yrs randomized either to crash cooling or gradient cooling, ten patients in each group.. Patients with severe comorbidities or known coagulopathy are excluded. Anesthesia and operation as performed routinely in the department. The primary endpoint is duration of cooling, secondary endpoints include coagulation parameters (thromboelastography, clot stability), stress response parameters (adhesion molecule expression on endothelial cells, oxidative stress analysis, inflammatory markers), neuropsychological tests, MRI of the cerebrum, markers of cerebral ischemia, and ultrasound imaging of the great vessels for detection of air bubbles. Baseline values are obtained for all parameters.
Interventions
None listed
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for surgery on the ascending aorta * Need for deep hypothermic circulatory arrest during the procedure
Exclusion criteria
* Known coagulopathy * Ejection fraction less than 30 % * Severe psychiatric or neurological disease * Severe liver disease * Severely reduced lung function * Glomerular filtration rate less than 15 ml/min/1.73 m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of cooling | intraoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Markers of neurological injury | baseline, postoperative | s-100b, Neuron specific enolase |
| neurological exam | baseline, postoperative, after 4 months | — |
| cognitive test | baseline, postoperative, after 4 months | — |
| MRI of cerebrum | Baseline prior to surgery and 4 to 5 days postoperatively | Standard perfusion-weighed Magnetic Resonance imaging of the cerebrum. The same investigator describes all images. No use of contrast agents. |
| Markers of oxidative stress | perioperatively | — |
| Coagulation parameters | perioperatively | — |
| markers of elevated inflammatory response | perioperatively | — |
Countries
Denmark
Contacts
Primary ContactHans Kirkegaard, MD, Ph.D.
Backup ContactKristian K Andersen, MD
Outcome results
None listed