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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 April 2016 |
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Main ID: |
NCT02185885 |
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Date of registration:
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07/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Perfusion Pressure Cerebral Infarction Trial (PPCI)
PPCI |
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Scientific title:
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The Importance of Mean Arterial Pressure During Cardiopulmonary Bypass to Prevent Cerebral Complications After Cardiac Surgery - a Randomised Clinical Trial. |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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197 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02185885 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Hanne B. Ravn, MD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Name:
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Jens C. Nilsson, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- = 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Cognitive Dysfunction
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Embolic Stroke
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Intervention(s)
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Procedure: Increased bloodpressure during CPB.
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Primary Outcome(s)
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Total volume of new ischemic cerebral lesions
[Time Frame: 6 days]
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Secondary Outcome(s)
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Peak value of biochemical markers of brain injury
[Time Frame: Prior to surgery on day 1 and 24 hours, 48 hours and 6 days after surgery]
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Near Infrared Spectroscopy (NIRS) - lowest value
[Time Frame: End of surgery]
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Near Infrared Spectroscopy (NIRS) - total time below 25% of the baseline value on right and left side
[Time Frame: End of surgery]
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Total number of new ischemic cerebral lesions
[Time Frame: 6 days]
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Change from baseline performance at neurological examination day 6
[Time Frame: 6 days]
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Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at 3 months
[Time Frame: 3 months]
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Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at day 5-8
[Time Frame: 5-8 days]
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Magnetic resonance spectroscopy - change from baseline MRS Choline-creatine (Cho/Cr ratio) at day 6
[Time Frame: 6 days]
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Magnetic resonance spectroscopy - change from baseline N-acetylaspartate-creatine (NAA/Cr) ratio at day 6
[Time Frame: 6 days]
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Secondary ID(s)
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E-22329-01
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4142, PPCI
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H-3-2013-110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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