Status:
COMPLETED
Perfusion Pressure Cerebral Infarction Trial (PPCI)
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Danish Heart Foundation
Conditions:
Embolic Stroke
Postoperative Cognitive Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
STUDY HYPOTHESIS In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure. BRIEF STUD...
Detailed Description
TRIAL DESIGN The PPCI trial is a randomized, controlled, outcomes assessor and patient blinded, single-center superiority trial with two parallel groups in a 1:1 allocation ratio. The randomization w...
Eligibility Criteria
Inclusion
- ≥ 18 years of age.
- scheduled elective or subacute cardiac surgery with the use of CPB.
- type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
Exclusion
- a history of stroke.
- a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
- a history of transitory ischemic attacks (duration of symptoms \< 24 hours)
- diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT02185885
Start Date
July 1 2014
End Date
April 1 2016
Last Update
April 11 2016
Active Locations (1)
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1
Department of Cardiothoracic Surgery 2152 and Department of Cardiothoracic Anesthesiology 4142, Rigshospitalet / Copenhagen University Hospital
Copenhagen, Denmark, DK-2100