Non-convulsive SeizuresNCT01291992
Seizures After Cardiac Surgery -- A Study With Continuous EEG Monitoring
An observational study of Non-convulsive Seizures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-convulsive Seizures
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the CSRU postoperatively who have given informed consent to have immediate and continous EEG monitoring for the first 24 hours postoperatively
Who may be able to join
- All adult patients able to give informed consent and undergoing cardiac surgery
Who cannot join
- Inability to record subhairline EEG data due to technical/mechanical reasons Patients not giving informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
About this study
Official title: Seizures After Cardiac Surgery -- A Prospective Study With Continuous EEG Monitoring
The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.
Read the detailed description
Background: Most patients do not have any neurological complications after cardiac surgery, but fewer than 1% may have a seizure (abnormal brain activity), with or without a convulsion. This can be due to a reaction to certain types of drugs or less commonly stroke or inflammation. Some seizures in post-operative and intensive care unit patients do not result in convulsions, but rather the abnormal brain activity simply causes confusion or unresponsiveness. The incidence of this type of "nonconvulsive"seizure after cardiac surgery is unknown.
Purpose of the study: The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.
Design of the study: The investigators target is to enroll 150 patients undergoing cardiac surgery. The investigators are including patients greater than 18 years of age who are admitted to the CSRU immediately after cardiac surgery. Included patients are of normal mentation and are able to give their own consent. The investigators will exclude only those patients for whom technical issues prevent us from recording the EEG.
- Conditions
- Non-convulsive Seizures
- Keywords
- Non-convulsive seizures, Cardiac Surgery, Postop, 24 hour EEG Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Continuous EEG Monitoring | Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of non-convulsive seizures in postoperative cardiac surgery patients
Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes will be applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation.
Measured: Immediate postoperative monitoring with continuous EEG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Non-convulsive SeizuresStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Michael Chu, MD, Principal investigator, London Health Sciences Centre, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291992
- Sponsor's protocol ID
- R-10-259
- Other IDs
- 17107
- Status last verified
- Mar 2018
- First submitted
- 7 Feb 2011
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bucerius J, Gummert JF, Borger MA, Walther T, Doll N, Onnasch JF, Metz S, Falk V, Mohr FW. Stroke after cardiac surgery: a risk factor analysis of 16,184 consecutive adult patients. Ann Thorac Surg. 2003 Feb;75(2):472-8. doi: 10.1016/s0003-4975(02)04370-9.
PubMed 12607656Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
PubMed 8948560Young GB, Jordan KG, Doig GS. An assessment of nonconvulsive seizures in the intensive care unit using continuous EEG monitoring: an investigation of variables associated with mortality. Neurology. 1996 Jul;47(1):83-9. doi: 10.1212/wnl.47.1.83.
PubMed 8710130Jordan KG. Continuous EEG and evoked potential monitoring in the neuroscience intensive care unit. J Clin Neurophysiol. 1993 Oct;10(4):445-75. doi: 10.1097/00004691-199310000-00006.
PubMed 8308143Furtmuller R, Schlag MG, Berger M, Hopf R, Huck S, Sieghart W, Redl H. Tranexamic acid, a widely used antifibrinolytic agent, causes convulsions by a gamma-aminobutyric acid(A) receptor antagonistic effect. J Pharmacol Exp Ther. 2002 Apr;301(1):168-73. doi: 10.1124/jpet.301.1.168.
PubMed 11907171Mohseni K, Jafari A, Nobahar MR, Arami A. Polymyoclonus seizure resulting from accidental injection of tranexamic acid in spinal anesthesia. Anesth Analg. 2009 Jun;108(6):1984-6. doi: 10.1213/ane.0b013e3181a04d69.
PubMed 19448237Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M. High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2010 Feb 1;110(2):350-3. doi: 10.1213/ANE.0b013e3181c92b23. Epub 2009 Dec 8.
PubMed 19996135Gofton TE, Chu MW, Norton L, Fox SA, Chase L, Murkin JM, Young GB. A prospective observational study of seizures after cardiac surgery using continuous EEG monitoring. Neurocrit Care. 2014 Oct;21(2):220-7. doi: 10.1007/s12028-014-9967-x.
PubMed 24710654
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seizures After Cardiac Surgery -- A Prospective Study With Continuous EEG Monitoring
- ClinicalTrials.gov ID
- NCT01291992
- Acronym / sponsor ID
- R-10-259
- Conditions
- Non-convulsive Seizures
- Keywords
- Non-convulsive seizures, Cardiac Surgery, Postop, 24 hour EEG Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.
Detailed description
Background: Most patients do not have any neurological complications after cardiac surgery, but fewer than 1% may have a seizure (abnormal brain activity), with or without a convulsion. This can be due to a reaction to certain types of drugs or less commonly stroke or inflammation. Some seizures in post-operative and intensive care unit patients do not result in convulsions, but rather the abnormal brain activity simply causes confusion or unresponsiveness. The incidence of this type of "nonconvulsive"seizure after cardiac surgery is unknown.
Purpose of the study: The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.
Design of the study: The investigators target is to enroll 150 patients undergoing cardiac surgery. The investigators are including patients greater than 18 years of age who are admitted to the CSRU immediately after cardiac surgery. Included patients are of normal mentation and are able to give their own consent. The investigators will exclude only those patients for whom technical issues prevent us from recording the EEG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous EEG Monitoring | – | –Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the CSRU postoperatively who have given informed consent to have immediate and continous EEG monitoring for the first 24 hours postoperatively
Key inclusion criteria (1 listed)
- All adult patients able to give informed consent and undergoing cardiac surgery
Key exclusion criteria (1 listed)
- Inability to record subhairline EEG data due to technical/mechanical reasons Patients not giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of non-convulsive seizures in postoperative cardiac surgery patients
Time frame: Immediate postoperative monitoring with continuous EEG
Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes will be applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Background: PubMed 12607656Bucerius J, Gummert JF, Borger MA, Walther T, Doll N, Onnasch JF, Metz S, Falk V, Mohr FW. Stroke after cardiac surgery: a risk factor analysis of 16,184 consecutive adult patients. Ann Thorac Surg. 2003 Feb;75(2):472-8. doi: 10.1016/s0003-4975(02)04370-9.
- Background: PubMed 8948560Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
- Background: PubMed 8710130Young GB, Jordan KG, Doig GS. An assessment of nonconvulsive seizures in the intensive care unit using continuous EEG monitoring: an investigation of variables associated with mortality. Neurology. 1996 Jul;47(1):83-9. doi: 10.1212/wnl.47.1.83.
- Background: PubMed 8308143Jordan KG. Continuous EEG and evoked potential monitoring in the neuroscience intensive care unit. J Clin Neurophysiol. 1993 Oct;10(4):445-75. doi: 10.1097/00004691-199310000-00006.
- Background: PubMed 11907171Furtmuller R, Schlag MG, Berger M, Hopf R, Huck S, Sieghart W, Redl H. Tranexamic acid, a widely used antifibrinolytic agent, causes convulsions by a gamma-aminobutyric acid(A) receptor antagonistic effect. J Pharmacol Exp Ther. 2002 Apr;301(1):168-73. doi: 10.1124/jpet.301.1.168.
- Background: PubMed 19448237Mohseni K, Jafari A, Nobahar MR, Arami A. Polymyoclonus seizure resulting from accidental injection of tranexamic acid in spinal anesthesia. Anesth Analg. 2009 Jun;108(6):1984-6. doi: 10.1213/ane.0b013e3181a04d69.
- Background: PubMed 19996135Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M. High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2010 Feb 1;110(2):350-3. doi: 10.1213/ANE.0b013e3181c92b23. Epub 2009 Dec 8.
- Derived from this study: PubMed 24710654Gofton TE, Chu MW, Norton L, Fox SA, Chase L, Murkin JM, Young GB. A prospective observational study of seizures after cardiac surgery using continuous EEG monitoring. Neurocrit Care. 2014 Oct;21(2):220-7. doi: 10.1007/s12028-014-9967-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chu, MD principal investigator
London Health Sciences Centre, University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-convulsive Seizures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of non-convulsive seizures in postoperative cardiac surgery patients (time frame: Immediate postoperative monitoring with continuous EEG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291992, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.