Embolic StrokePPCINCT02185885
Perfusion Pressure Cerebral Infarction Trial (PPCI)
A study testing Increased bloodpressure during CPB. in people with Embolic Stroke and Postoperative Cognitive Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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 STUDY SUMMARY Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolic Stroke, Postoperative Cognitive Dysfunction
- What is being tested?
- Increased bloodpressure during CPB.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2014to Apr 2016
- Phase
- Interventional
- 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
Who may be able to join
- ≥ 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic Surgery 2152 and Department of Cardiothoracic Anesthesiology 4142, Rigshospitalet / Copenhagen University Hospital
Copenhagen, DK-2100
About this study
Official title: The Importance of Mean Arterial Pressure During Cardiopulmonary Bypass to Prevent Cerebral Complications After Cardiac Surgery - a Randomised Clinical Trial.
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.
Read more
BRIEF STUDY SUMMARY
Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain. Previous studies using brain scans have reported small stroke-like lesions in up to 51% of patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of severe brain damage.
The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since sufficient total blood flow is guaranteed during CPB.
The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce the extent of brain injury after cardiac surgery. A beneficial effect could result from reduced embolic injury through increased blood flow in collateral vessels and/or by increased blood flow in calcified arteries.
180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80 mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is intended equal and fixed in the two groups. Patients are examined before and 3-6 days after surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne markers of brain injury.
If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the clinical routine.
Read the 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 will be stratified according to age (stratum 1 < 70 years; stratum 2 ≥ 70 years) and type of surgery (stratum 1 - surgery involving the aortic and/or mitral valve; stratum 2 - surgery not involving these valves).
- Being tested
- Increased bloodpressure during CPB.
- Keywords
- Ischemic stroke, Embolic stroke, Postoperative Cognitive Dysfunction, Cardiac Bypass Surgery, Cardiac Anaesthesia
- Medical subject headings
- Embolic Stroke, Postoperative Cognitive Complications, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased bloodpressure during CPB.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Increased bloodpressure during CPB | Experimental | The cardiopulmonary bypass (CPB) procedure is conducted according to department guidelines with the modification that MAP is kept between 70 and 80 mm Hg. This is achieved by refract intravenous doses of phenylephrine to a total maximum of 2.0 mg, and after that continuous intravenous infusion of norepinephrine up to 0.4 μg/kg/min if necessary. Receives: Procedure: Increased bloodpressure during CPB. |
| Regular bloodpressure during CPB | No intervention | The cardiopulmonary bypass (CPB) procedure is conducted in accordance with departmental guidelines, where MAP is sought to be ≥ 45 mm Hg. This is achieved by refract intravenous doses of phenylephrine to a total maximum of 2.0 mg, and after that continuous intravenous infusion of norepinephrine up to 0.4 μg/kg/min if necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of new ischemic cerebral lesions
The total volume of new ischemic cerebral lesions (sum in mL) assessed by diffusion-weighed-magnetic resonance imaging conducted preoperatively and again once postoperatively on day 3 to 6.
The analysis will be adjusted for the randomization stratification variables age and type of surgery.
Measured: 6 days
Secondary outcomes (9)
Total number of new ischemic cerebral lesions
The total number of new ischemic cerebral lesions (sum in mL) assessed by diffusion-weighed-magnetic resonance imaging conducted preoperatively and again once postoperatively on day 3 to 6.
Measured: 6 days
Magnetic resonance spectroscopy - change from baseline N-acetylaspartate-creatine (NAA/Cr) ratio at day 6
Diffuse cerebral injury is investigated using Single-Voxel Magnetic Resonance Spectroscopy (MRS) in grey and white cerebral matter and expressed as the difference in N-acetylaspartate-creatine (NAA/Cr) ratio between a scan conducted preoperatively and one conducted postoperatively on day 3 to 6.
Measured: 6 days
Magnetic resonance spectroscopy - change from baseline MRS Choline-creatine (Cho/Cr ratio) at day 6
Diffuse cerebral injury is investigated using Single-Voxel Magnetic Resonance Spectroscopy (MRS) in grey and white cerebral matter and expressed as the difference in Choline-creatine (Cho/Cr ratio) between a scan conducted preoperatively and one conducted postoperatively on day 3 to 6.
Measured: 6 days
Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at day 5-8
The presence of cognitive dysfunction is evaluated preoperatively and on day 5-8 using the following collection of specific tests each time: "Visual Verbal Learning test", "Concept Shifting test", "Stroop Colour Word Interference test" and "Letter Digit Coding test".
Cognitive dysfunction is defined as a deterioration corresponding to a Z-score > 2 (as defined by the ISPOCD group).
Measured: 5-8 days
Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at 3 months
The presence of cognitive dysfunction is evaluated preoperatively and 3 months postoperatively using the following collection of specific tests each time: "Visual Verbal Learning test", "Concept Shifting test", "Stroop Colour Word Interference test" and "Letter Digit Coding test".
Cognitive dysfunction is defined as a deterioration corresponding to a Z-score > 2 (as defined by the ISPOCD group).
Measured: 3 months
Peak value of biochemical markers of brain injury
Blood samples will be drawn at 4 different time points during the admission. Serum concentration and time course of the following markers of brain injury will be assessed: Phosphorylated Neurofilament Heavy Protein (pNfH), Glial Fibrillary Acidic Protein (GFAP), Matrix Metallopeptidase 9 (MMP-9) and Ubiquitin C-terminal Hydrolase 1 (UCH-L1).
Measured: Prior to surgery on day 1 and 24 hours, 48 hours and 6 days after surgery
Near Infrared Spectroscopy (NIRS) - lowest value
Near Infrared Spectroscopy (NIRS) NIRS values from the right and left frontal lobes of the brain will be continuously monitored during the intraoperative period and saved for later analysis. The NIRS monitor will be hidden and muted during the procedure.
Measured: End of surgery
Near Infrared Spectroscopy (NIRS) - total time below 25% of the baseline value on right and left side
Near Infrared Spectroscopy (NIRS) NIRS values from the right and left frontal lobes of the brain will be continuously monitored during the intraoperative period and saved for later analysis. The NIRS monitor will be hidden and muted during the procedure.
Measured: End of surgery
Change from baseline performance at neurological examination day 6
New neurological deficits are assessed by performing an objective, clinical neurological examination.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Embolic StrokeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Principal investigator, Jens C. Nilsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens C. Nilsson, MD, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletHanne B. Ravn, MD, DMSc, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185885
- Sponsor's protocol ID
- H-3-2013-110
- Other IDs
- E-22329-01, 4142, PPCI
- Acronym
- PPCI
- Status last verified
- Apr 2016
- First submitted
- 7 Jul 2014
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
PubMed 9525362Vedel AG, Holmgaard F, Danielsen ER, Langkilde A, Paulson OB, Ravn HB, Rasmussen LS, Nilsson JC. Blood pressure and brain injury in cardiac surgery: a secondary analysis of a randomized trial. Eur J Cardiothorac Surg. 2020 Nov 1;58(5):1035-1044. doi: 10.1093/ejcts/ezaa216.
PubMed 32840297Holmgaard F, Vedel AG, Rasmussen LS, Paulson OB, Nilsson JC, Ravn HB. The association between postoperative cognitive dysfunction and cerebral oximetry during cardiac surgery: a secondary analysis of a randomised trial. Br J Anaesth. 2019 Aug;123(2):196-205. doi: 10.1016/j.bja.2019.03.045. Epub 2019 May 17.
PubMed 31104758Holmgaard F, Vedel AG, Lange T, Nilsson JC, Ravn HB. Impact of 2 Distinct Levels of Mean Arterial Pressure on Near-Infrared Spectroscopy During Cardiac Surgery: Secondary Outcome From a Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1081-1088. doi: 10.1213/ANE.0000000000003418.
PubMed 31094772Holmgaard F, Vedel AG, Langkilde A, Lange T, Nilsson JC, Ravn HB. Differences in regional cerebral oximetry during cardiac surgery for patients with or without postoperative cerebral ischaemic lesions evaluated by magnetic resonance imaging. Br J Anaesth. 2018 Dec;121(6):1203-1211. doi: 10.1016/j.bja.2018.05.074. Epub 2018 Jul 26.
PubMed 30442245Vedel AG, Holmgaard F, Rasmussen LS, Langkilde A, Paulson OB, Lange T, Thomsen C, Olsen PS, Ravn HB, Nilsson JC. High-Target Versus Low-Target Blood Pressure Management During Cardiopulmonary Bypass to Prevent Cerebral Injury in Cardiac Surgery Patients: A Randomized Controlled Trial. Circulation. 2018 Apr 24;137(17):1770-1780. doi: 10.1161/CIRCULATIONAHA.117.030308. Epub 2018 Jan 16.
PubMed 29339351Vedel AG, Holmgaard F, Rasmussen LS, Paulson OB, Thomsen C, Danielsen ER, Langkilde A, Goetze JP, Lange T, Ravn HB, Nilsson JC. Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery: study protocol for a randomised controlled trial. Trials. 2016 May 17;17(1):247. doi: 10.1186/s13063-016-1373-6.
PubMed 27189028
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Mean Arterial Pressure During Cardiopulmonary Bypass to Prevent Cerebral Complications After Cardiac Surgery - a Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT02185885
- Acronym / sponsor ID
- PPCI / H-3-2013-110
- Keywords
- Ischemic stroke, Embolic stroke, Postoperative Cognitive Dysfunction, Cardiac Bypass Surgery, Cardiac Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Jul 2014 (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.
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 STUDY SUMMARY
Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain. Previous studies using brain scans have reported small stroke-like lesions in up to 51% of patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of severe brain damage.
The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since sufficient total blood flow is guaranteed during CPB.
The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce the extent of brain injury after cardiac surgery. A beneficial effect could result from reduced embolic injury through increased blood flow in collateral vessels and/or by increased blood flow in calcified arteries.
180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80 mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is intended equal and fixed in the two groups. Patients are examined before and 3-6 days after surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne markers of brain injury.
If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the clinical routine.
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 will be stratified according to age (stratum 1 < 70 years; stratum 2 ≥ 70 years) and type of surgery (stratum 1 - surgery involving the aortic and/or mitral valve; stratum 2 - surgery not involving these valves).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased bloodpressure during CPB | Experimental | Procedure: Increased bloodpressure during CPB.The cardiopulmonary bypass (CPB) procedure is conducted according to department guidelines with the modification that MAP is kept between 70 and 80 mm Hg. This is achieved by refract intravenous doses of phenylephrine to a total maximum of 2.0 mg, and after that continuous intravenous infusion of norepinephrine up to 0.4 μg/kg/min if necessary. |
| Regular bloodpressure during CPB | No intervention | –The cardiopulmonary bypass (CPB) procedure is conducted in accordance with departmental guidelines, where MAP is sought to be ≥ 45 mm Hg. This is achieved by refract intravenous doses of phenylephrine to a total maximum of 2.0 mg, and after that continuous intravenous infusion of norepinephrine up to 0.4 μg/kg/min if necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased bloodpressure during CPB. | Procedure or surgery | Increased bloodpressure during CPB |
Primary outcome
Total volume of new ischemic cerebral lesions
Time frame: 6 days
The total volume of new ischemic cerebral lesions (sum in mL) assessed by diffusion-weighed-magnetic resonance imaging conducted preoperatively and again once postoperatively on day 3 to 6. The analysis will be adjusted for the randomization stratification variables age and type of surgery.
9 secondary outcomes
Total number of new ischemic cerebral lesions
Time frame: 6 days
Magnetic resonance spectroscopy - change from baseline N-acetylaspartate-creatine (NAA/Cr) ratio at day 6
Time frame: 6 days
Magnetic resonance spectroscopy - change from baseline MRS Choline-creatine (Cho/Cr ratio) at day 6
Time frame: 6 days
Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at day 5-8
Time frame: 5-8 days
Postoperative cognitive dysfunction (POCD) - change from baseline neuropsychological test performance at 3 months
Time frame: 3 months
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
Near Infrared Spectroscopy (NIRS) - lowest value
Time frame: End of surgery
Near Infrared Spectroscopy (NIRS) - total time below 25% of the baseline value on right and left side
Time frame: End of surgery
Change from baseline performance at neurological examination day 6
Time frame: 6 days
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 11 Apr 2016.
- Background: PubMed 9525362Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
- Derived from this study: PubMed 32840297Vedel AG, Holmgaard F, Danielsen ER, Langkilde A, Paulson OB, Ravn HB, Rasmussen LS, Nilsson JC. Blood pressure and brain injury in cardiac surgery: a secondary analysis of a randomized trial. Eur J Cardiothorac Surg. 2020 Nov 1;58(5):1035-1044. doi: 10.1093/ejcts/ezaa216.
- Derived from this study: PubMed 31104758Holmgaard F, Vedel AG, Rasmussen LS, Paulson OB, Nilsson JC, Ravn HB. The association between postoperative cognitive dysfunction and cerebral oximetry during cardiac surgery: a secondary analysis of a randomised trial. Br J Anaesth. 2019 Aug;123(2):196-205. doi: 10.1016/j.bja.2019.03.045. Epub 2019 May 17.
- Derived from this study: PubMed 31094772Holmgaard F, Vedel AG, Lange T, Nilsson JC, Ravn HB. Impact of 2 Distinct Levels of Mean Arterial Pressure on Near-Infrared Spectroscopy During Cardiac Surgery: Secondary Outcome From a Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1081-1088. doi: 10.1213/ANE.0000000000003418.
- Derived from this study: PubMed 30442245Holmgaard F, Vedel AG, Langkilde A, Lange T, Nilsson JC, Ravn HB. Differences in regional cerebral oximetry during cardiac surgery for patients with or without postoperative cerebral ischaemic lesions evaluated by magnetic resonance imaging. Br J Anaesth. 2018 Dec;121(6):1203-1211. doi: 10.1016/j.bja.2018.05.074. Epub 2018 Jul 26.
- Derived from this study: PubMed 29339351Vedel AG, Holmgaard F, Rasmussen LS, Langkilde A, Paulson OB, Lange T, Thomsen C, Olsen PS, Ravn HB, Nilsson JC. High-Target Versus Low-Target Blood Pressure Management During Cardiopulmonary Bypass to Prevent Cerebral Injury in Cardiac Surgery Patients: A Randomized Controlled Trial. Circulation. 2018 Apr 24;137(17):1770-1780. doi: 10.1161/CIRCULATIONAHA.117.030308. Epub 2018 Jan 16.
- Derived from this study: PubMed 27189028Vedel AG, Holmgaard F, Rasmussen LS, Paulson OB, Thomsen C, Danielsen ER, Langkilde A, Goetze JP, Lange T, Ravn HB, Nilsson JC. Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery: study protocol for a randomised controlled trial. Trials. 2016 May 17;17(1):247. doi: 10.1186/s13063-016-1373-6.
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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.
Jens C. Nilsson, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Hanne B. Ravn, MD, DMSc study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased bloodpressure during CPB. in people with Embolic Stroke and Postoperative Cognitive Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 4 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 11 Apr 2016. 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 Denmark. 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?
Total volume of new ischemic cerebral lesions (time frame: 6 days). 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 NCT02185885, which also lists 7 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 11 Apr 2016.