Ascending Aorta Aneurism Clinical Trial
Official title:
Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01456975 -
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
|
N/A |