Ascending Aorta AneurismNCT01306734
Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods
An observational study of Ascending Aorta Aneurism, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ascending Aorta Aneurism
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care clinic. Patients eligible for planned ascending aorta aneurism repair under deep hypothermic circulatory arrest.
Who may be able to join
- Patients scheduled for surgery on the ascending aorta
- Need for deep hypothermic circulatory arrest during the procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of anesthesia and intensive care, Aarhus University Hospital, Skejby
Aarhus, Aarhus N, 8200
Kristian K Andersen, MD, kristianka@gmail.com
Hans Kirkegaard, MD, Ph.D.
About this study
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.
- Conditions
- Ascending Aorta Aneurism
- Keywords
- Extracorporeal circulation, Deep Hypothermic Circulatory Arrest, aortic aneurism, neurological injury, inflammation, coagulation
- Medical subject headings
- Trauma, Nervous System, Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gradient cooling group | Study group receiving gradient cooling during the procedure using extracorporeal circulation (ECC). The procedure is used routinely in the department and is not an experimental procedure. A maximum of 10 degrees celsius is allowed between the measured nasopharyngeal body temperature and the heater-cooler unit of the ECC-machine, when cooling or rewarming. | |
| Crash cooling group | Study group receiving rapid cooling using extracorporeal circulation. The protocol for rapid cooling is using routinely in the department and is not an experimental procedure. When cooling, the investigators aim for maximal difference in temperature between the heater-cooler unit of the ECC-machine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of cooling
Measured: intraoperatively
Secondary outcomes (7)
MRI of cerebrum
Standard perfusion-weighed Magnetic Resonance imaging of the cerebrum. The same investigator describes all images. No use of contrast agents.
Measured: Baseline prior to surgery and 4 to 5 days postoperatively
Markers of neurological injury
s-100b, Neuron specific enolase
Measured: baseline, postoperative
neurological exam
Measured: baseline, postoperative, after 4 months
cognitive test
Measured: baseline, postoperative, after 4 months
markers of elevated inflammatory response
Measured: perioperatively
Markers of oxidative stress
Measured: perioperatively
Coagulation parameters
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aorta AneurismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306734
- Sponsor's protocol ID
- HYPO-SKS-2011
- Status last verified
- Mar 2012
- First submitted
- 7 Jan 2011
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods
- ClinicalTrials.gov ID
- NCT01306734
- Acronym / sponsor ID
- HYPO-SKS-2011
- Conditions
- Ascending Aorta Aneurism
- Keywords
- Extracorporeal circulation, Deep Hypothermic Circulatory Arrest, aortic aneurism, neurological injury, inflammation, coagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gradient cooling group | – | –Study group receiving gradient cooling during the procedure using extracorporeal circulation (ECC). The procedure is used routinely in the department and is not an experimental procedure. A maximum of 10 degrees celsius is allowed between the measured nasopharyngeal body temperature and the heater-cooler unit of the ECC-machine, when cooling or rewarming. |
| Crash cooling group | – | –Study group receiving rapid cooling using extracorporeal circulation. The protocol for rapid cooling is using routinely in the department and is not an experimental procedure. When cooling, the investigators aim for maximal difference in temperature between the heater-cooler unit of the ECC-machine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic. Patients eligible for planned ascending aorta aneurism repair under deep hypothermic circulatory arrest.
Key inclusion criteria (2 listed)
- Patients scheduled for surgery on the ascending aorta
- Need for deep hypothermic circulatory arrest during the procedure
Key exclusion criteria (6 listed)
- Known coagulopathy
- Ejection fraction less than 30 %
- Severe psychiatric or neurological disease
- Severe liver disease
- Severely reduced lung function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of cooling
Time frame: intraoperatively
7 secondary outcomes
MRI of cerebrum
Time frame: Baseline prior to surgery and 4 to 5 days postoperatively
Markers of neurological injury
Time frame: baseline, postoperative
neurological exam
Time frame: baseline, postoperative, after 4 months
cognitive test
Time frame: baseline, postoperative, after 4 months
markers of elevated inflammatory response
Time frame: perioperatively
Markers of oxidative stress
Time frame: perioperatively
Coagulation parameters
Time frame: perioperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascending Aorta Aneurism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Kirkegaard, MD, Ph.D. (+4589498852, hans.kirkegaard@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of cooling (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.