- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432536
Redesigning Cardiac Surgery to Reduce Neurologic Injury
Neurologic injuries are frequent and devastating complications following cardiac surgery. Previous work conducted by our research group and others has identified the principal mechanisms creating both overt and subtle neurologic injuries after cardiac surgery. Current work by our group has identified that the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of these injuries are byproducts of processes of surgical and perfusion care. This insight suggests that the redesign of clinical strategies and techniques to prevent the occurrence of these intraoperative sources of damage may provide an opportunity to reduce the risk of neurologic injury after cardiac surgery.
The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of neurologic injury secondary to coronary artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a patient's risk of a neurologic injury.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of neurologic injury secondary to coronary artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a patient's risk of a neurologic injury. The following hypotheses will be addressed.
Hypothesis #1a. Identifying alternative strategies for conducting processes of surgical and perfusion care will reveal opportunities to reduce the occurrence of causes of neurologic injury. The most common mechanisms creating neurologic injury, whether focal or global, after CABG surgery are thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli. Processes of surgical and perfusion care are associated with the creation of each of these causes of neurologic injury.
Hypothesis #1b. Redesigning processes of surgical and perfusion care to reduce thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli during CABG surgery will result in reductions of tissue-level and neurologic injury. We will analyze sera for tissue-level brain injury as well as identify any new neurologic injuries present among patients undergoing CABG surgery. Redesigning CABG surgery to reduce thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli will result in decreases in tissue-level and neurologic injury.
Hypothesis #2. A regional quality improvement intervention will result in changes to surgical and perfusion techniques. Regional dissemination of the findings from Hypotheses #1a,b may be realized through focused quality improvement initiatives utilizing multidisciplinary clinical teams.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Manchester, New Hampshire, United States, 03102
- Catholic Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 40-89 years undergoing nonemergency coronary revascularization or valve procedures with or without the use of a cardiopulmonary bypass circuit.
Exclusion Criteria:
- Undergoing concomitant procedures besides cardiac surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emboli and Hypoperfusion Counts
Time Frame: within the operative time period
|
We will count the number of thrombotic/lipid emboli and number of gaseous emboli.
Along with the number of hypotensive events.
We will link counts to surgical and perfusion techniques.
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within the operative time period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type I and II neurologic injuries
Time Frame: within 3 months after surgery
|
We will measure a patient's neurologic status Using a Telephone Interview for Cognitive Status tool at 3 time periods (prior to surgery, prior to discharge and at 3 months)
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within 3 months after surgery
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Tissue-level neurologic injury
Time Frame: within 48 hrs of surgery
|
Blood for serum markers will be collected after surgery.
We will assess plasma levels of biochemical markers of neurology injury.
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within 48 hrs of surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Donald S Likosky, Ph.D., Dartmouth-Hitchcock Medical Center
- Study Director: David J. Malenka, MD, Dartmouth-Hitchcock Medical Center
Publications and helpful links
General Publications
- Likosky DS, Donegan DJ, Groom RC, Buchanan SA, Morton JR, Ross CS, O'Connor GT. Embolic activity subsequent to injection of the internal mammary artery with papaverine hydrochloride. Heart Surg Forum. 2005;8(6):E434-6. doi: 10.1532/HSF98.20051012.
- Likosky DS, Groom RC, Clark C, Forest RJ, Kramer RS, Morton JR, Ross CS, Sabadosa KA, O'Connor GT; Northern New England Cardiovascular Disease Study Group, Lebanon, New Hampshire. A method for identifying mechanisms of neurologic injury from cardiac surgery. Heart Surg Forum. 2004;7(6):348-52. doi: 10.1532/HSF98.20041088.
- Groom R, Likosky DS, Rutberg H. Understanding variation in cardiopulmonary bypass: Statistical Process Control Theory. J Extra Corpor Technol. 2004 Sep;36(3):224-30. No abstract available.
- Groom RC, Likosky DS, Forest RJ, O'Connor GT, Morton JR, Ross CS, Clark C, Kramer R. A model for cardiopulmonary bypass redesign. Perfusion. 2004 Jul;19(4):257-61. doi: 10.1191/0269216304pf749oa.
- Groom RC, Quinn RD, Lennon P, Welch J, Kramer RS, Ross CS, Beaulieu PA, Brown JR, Malenka DJ, O'Connor GT, Likosky DS; Northern New England Cardiovascular Disease Study Group. Microemboli from cardiopulmonary bypass are associated with a serum marker of brain injury. J Extra Corpor Technol. 2010 Mar;42(1):40-4.
- Groom RC, Quinn RD, Lennon P, Donegan DJ, Braxton JH, Kramer RS, Weldner PW, Russo L, Blank SD, Christie AA, Taenzer AH, Forest RJ, Clark C, Welch J, Ross CS, O'Connor GT, Likosky DS; Northern New England Cardiovascular Disease Study Group. Detection and elimination of microemboli related to cardiopulmonary bypass. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):191-8. doi: 10.1161/CIRCOUTCOMES.108.803163. Epub 2009 May 5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20307
- 1K02HS015663-01A1 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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