Please select the eligibility criteria that correspond to the clinical trial below.
Title: Neuroprotection In Patients Undergoing Aortic Valve Replacement
Brief Summary: To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).


Options:
A: Inclusion Criteria:

* Age ≥ 50 years
* ASA score ≥ 2
* Planned and unplanned surgical procedures
* Abdominal, orthopaedic and vascular surgery
* Expected duration ≥ 2 hours
* AKI risk index ≥ class 3

Exclusion Criteria:

* Severe preoperative hypertension (not controlled)
* Creatinine clearance \< 30 ml/min or preoperative dialysis
* Acute cardiac failure
* Preoperative sepsis
* Preoperative hemodynamic failure (shock)
* Intraoperative use of locoregional anaesthesia (epidural and spinal)
* Patient refusal
* Pregnancy and/or lactation
B: Inclusion Criteria:

* hospitalized in intensive care unit for less than 7 days
* septic shock for less than 24 hours
* at least one proven site of infection
* at least 2 organ dysfunction as defined by a SOFA score =or\> to 3 for at least 6 consecutive hours
* need for vasopressor (dopamine =or\>15µg/kg/min or epinephrine/norepinephrine at =or\>0,25 µg/kg/min for at least 6 consecutive hours, to maintain systolic arterial pressure at 90 mmHg or more OR mean arterial pressure at 6( mmHg or more
* informed consent

Exclusion Criteria:

* pregnancy or breath feeding
* decision not to resuscitate
* underlying disease with an estimated life expectancy of less than 1 month
* formal indication for corticosteroids
* recent surgery (ie within the past 72 hours) or a surgery at high risk of bleeding
* gastro-intestinal bleeding within the past 6 weeks
* chronic liver disease (Child C)
* recent trauma (ie within the past 72 hours)
* intracranial process
* history of stroke, CNS bleeding or traumatic brain injury within the past 3 months
* platelet counts of less than 30000 per cubic millimeter
* formal indication for curative anticoagulant; prophylactic use of heparin is allowed
* any condition of high risk of bleeding as per patient's primary physicians
* hypersensitivity of activated drotrecogin alpha or any other component of the drug
* no affiliation to a social security

Amendments to eligibility criteria were:

On 27/03/2008: Changes in following exclusion criteria :

* "surgical procedure in the past 7 days" was changed for "surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h".
* "chronic liver disease" was clarified as "chronic liver disease with Child score C".
* "severe thrombopenia" was clarified "as severe thrombopenia (\<30,000/mm3, before transfusion).

On 25/08/2009: The exclusion criteria: surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h" was changed for "surgical procedure within 12 hours, or any surgery associated with high risk of bleeding

On 11/06/2010: the inclusion criteria: admitted to the ICU for \< 7 days was removed; and a new exclusion criteria was added: "patients who had a previous episode of sepsis during the same hospital stay

On 18/04/2012: following the withdrawal of DAA from the market: the following exclusion criteria (only related to DAA) were removed :

1. any surgery in the past 12 hours, or any surgery associated with high risk of bleeding;
2. chronic liver disease with a Child score C;
3. recent trauma;
4. any intracranial mass, or stroke or head injury in the past 3 months;
5. severe thrombocytopenia (\< 30.000 /mm3, before platelet transfusion);
6. formal indication for anticoagulation, or any other condition associated with increased risk of bleeding, as appreciated by the patient's physician.
C: Inclusion Criteria:

* Age ≥ 60 years
* Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
* No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
* Ability to provide informed consent and comply with the protocol

Exclusion Criteria:

* Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)
* History of clinical stroke within 3 months prior to randomization
* Cardiac catheterization within 3 days of the planned aortic valve replacement
* Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
* Active endocarditis at time of randomization
* Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)
* Any other concomitant aortic procedure such as root replacement
* Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure
* Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
* Concurrent participation in an interventional (drug or device) trial
D: Inclusion Criteria:

* Patients will be included if they are adult, patients in a medical and/or surgical ICU receiving treatment for any of the following: respiratory failure or cardiogenic or septic shock.

Exclusion Criteria:

Patients who meet the inclusion criteria will be excluded if they meet any of the following criteria:

* Cumulative ICU time \>5 days in the past 30 days, not including the current ICU stay, as this might create a state of flux regarding patients' cognitive baseline
* Severe cognitive or neurodegenerative diseases that prevent a patient from living independently at baseline, including mental illness requiring institutionalization, acquired or congenital mental retardation, known brain lesions, traumatic brain injury, cerebrovascular accidents with resultant moderate to severe cognitive deficits or ADL dependency, Parkinson's disease, Huntington's disease, severe Alzheimer's disease or dementia of any etiology
* ICU admission post cardiopulmonary resuscitation with suspected anoxic injury
* An active substance abuse or psychotic disorder, or a recent (within the past 6 months) serious suicidal gesture necessitating hospitalization. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact
* Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the follow-up evaluation interviews.
* Overly moribund and not expected to survive for an additional 24 hours and / or withdrawing life support to focus on comfort measures only.
* Prisoners.
* Patients who live further than 200 miles from Nashville and who do not regularly visit the Nashville area.
* Patients who are homeless and have no secondary contact person available. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact
* The onset of the current episode of respiratory failure, cardiogenic shock, or septic shock was \> 72 hours ago.
* Patients who have had cardiac bypass surgery within the past 3 months (including the current hospitalization)

Answer: C