NCT00432536|Completed
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Sponsor study identifier
Secondary identifiers
observational
469
1 country
3
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
February 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
February 7, 2007
Actual (reported)February 8, 2007
Actual (reported)August 2011
Actual (reported)February 2012
Actual (reported)Emboli and Hypoperfusion Counts
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.
within the operative time period
Type I and II neurologic injuries
within 3 months after surgery
Tissue-level neurologic injury
within 48 hrs of surgery
determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients undergoing cardiac surgery.
Maine Medical Center
Portland, Maine, 04102, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
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.
Serum to study neurologic biomarker, Sb100.
Donald S Likosky, Ph.D.
Dartmouth-Hitchcock Medical Center
David J. Malenka, MD
Dartmouth-Hitchcock Medical Center
469 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2007
First Posted
February 8, 2007
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care
Contact the study team to confirm eligibility.
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.
Primary Completion
August 2011
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
May 16, 2013
Record last verified: 2013-05
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