Status:
COMPLETED
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
Lead Sponsor:
Maria Cecilia Hospital
Conditions:
Cardiac Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Age is no longer an absolute contraindication to cardiac surgery therefore there is often need for combined interventions (double valve repair/replacement, or coronary artery bypass graft and valve re...
Eligibility Criteria
Inclusion
- Signature of informed consent for participation in the study
- Age ≥65 years
- Patients undergoing cardiac surgery of:
- coronary artery bypass graft and concomitant valve replacement/repair OR
- double valve replacement/repair
Exclusion
- Any documented history of cognitive impairment estimated as a mini mental state examination \< 24 points
- Patients who need blood prime in the cardiopulmonary bypass circuit
- Chronic coagulopathies ( international normalized ratio \> 2 in patients without anticoagulant treatment)
- End stage renal disease on dialysis treatment
- Previous cerebrovascular accident
- Active cancer or immunological diseases
- Liver cirrhosis (platelets \<100.000/uL)
- Decompensated diabetes
- Severe preoperative anemia (hemoglobin \<8 g/dl).
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04062396
Start Date
September 26 2019
End Date
January 23 2023
Last Update
February 20 2024
Active Locations (1)
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1
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48010