Coronary Artery DiseasePhase 4ROCsafeTMNCT00862160
Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit
A Phase 4 study testing ROCsafeTM in people with Coronary Artery Disease and Acute Cerebrovascular Accident, run by Hannover Medical School at 2 sites in Germany.
Trial summary
The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Acute Cerebrovascular Accident, Intracranial Embolism
- What is being tested?
- ROCsafeTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2009to Oct 2010
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is older than 17 years
- Patient is acceptable candidate for CABG operation
- Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
Who cannot join
- Ejection fraction less than 30 %
- Valve surgery
- Acute endocarditis or history of endocarditis
- Cerebral ischemia within 4 weeks before surgery
- Detection of intracardial thrombi in preoperative echocardiography
- Stenosis of A. carotis int. greater than 70 %
Show all 17Show fewer
- Patients older than 80 years
- Patients on dialysis
- Acute myocardial ischemia or infarction within two weeks before inclusion
- Markedly elevated baseline C-reactive protein (CRP) or leucocytosis
- Cancer or immunologic diseases
- Dysregulation of the coagulation cascade (not concerning INR or PTT under cumarin or heparin treatment)
- Intake of steroids or NSAR
- Female of childbearing potential
- Participation in an other study
- Contraindication for MRI (e.g. pacemaker, any kind of implanted metal)
- Claustrophobia
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Braunschweig, Department of Cardiothoracic Surgery
Braunschweig, 38126
Wolfgang Harringer, PD Dr. med., 0049-531-595-2213, w.harringer@klinikum-braunschweig.de
Aschraf El Essawi, Dr. med., 0049-531-595-2213, a.elessawi@klinikum-braunschweig.de
- Recruiting
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Hanover, 30625
Ingo Kutschka, PD Dr. med., 0049-511-532-2154, kutschka.ingo@mh-hannover.de
Christian Hagl, PD Dr. med., 0049-511-532-3447, hagl.christian@mh-hannover.de
About this study
Official title: Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass
The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.
Read the detailed description
Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using cardiopulmonary bypass.
- Conditions
- Coronary Artery Disease, Acute Cerebrovascular Accident, Intracranial Embolism, Embolism, Air
- Being tested
- ROCsafeTM
- Keywords
- coronary artery bypass surgery, cardiopulmonary bypass, heart lung machine, acute cerebrovascular event, intracranial embolism, embolism, air, outcome assessment (health care), neuropsychological tests, magnetic resonance imaging, saccadic eye movement test
- Medical subject headings
- Coronary Artery Disease, Stroke, Intracranial Embolism, Embolism, Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROCsafeTMDevice
using minimized perfusion circuit while CABG
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | using minimized cardiopulmonary bypass circuit ROCsafeTM Receives: Device: ROCsafeTM |
| 2 | No intervention | using standard cardiopulmonary bypass circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
fresh micro-lesions in cranial MRT
Measured: before and 72 h after CABG
Secondary outcomes (3)
Death
Measured: 30 days after CABG
Neurological events
Measured: between CABG and discharge
Neurocognitive function
Measured: before and 3-4 days after CABG and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Teaching Hospital Braunschweig, Terumo Europe N.V.
- Investigators
- Ingo Kutschka, PD Dr. med., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862160
- Sponsor's protocol ID
- T201E1
- Acronym
- ROCsafeTM
- Status last verified
- Oct 2009
- First submitted
- 13 Mar 2009
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00862160
- Acronym / sponsor ID
- ROCsafeTM / T201E1
- Conditions
- Coronary Artery Disease, Acute Cerebrovascular Accident, Intracranial Embolism, Embolism, Air
- Keywords
- coronary artery bypass surgery, cardiopulmonary bypass, heart lung machine, acute cerebrovascular event, intracranial embolism, embolism, air, outcome assessment (health care), neuropsychological tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Academic Teaching Hospital Braunschweig, Terumo Europe N.V.
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 16 Mar 2009 (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 prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.
Detailed description
Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using cardiopulmonary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: ROCsafeTMusing minimized cardiopulmonary bypass circuit ROCsafeTM |
| 2 | No intervention | –using standard cardiopulmonary bypass circuit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is older than 17 years
- Patient is acceptable candidate for CABG operation
- Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
Key exclusion criteria (17 listed)
- Ejection fraction less than 30 %
- Valve surgery
- Acute endocarditis or history of endocarditis
- Cerebral ischemia within 4 weeks before surgery
- Detection of intracardial thrombi in preoperative echocardiography
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 |
|---|---|---|
| ROCsafeTMusing minimized perfusion circuit while CABG | Device | 1 |
Primary outcome
fresh micro-lesions in cranial MRT
Time frame: before and 72 h after CABG
3 secondary outcomes
Death
Time frame: 30 days after CABG
Neurological events
Time frame: between CABG and discharge
Neurocognitive function
Time frame: before and 3-4 days after CABG and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
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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.
Ingo Kutschka, PD Dr. med. principal investigator
Hannover Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ROCsafeTM in people with Coronary Artery Disease and Acute Cerebrovascular Accident, run by Hannover Medical School at 2 sites in Germany.
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 17 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: status not confirmed, as of the sponsor's last update on 7 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingo Kutschka, PD Dr. med. (0049-511-532-2154, kutschka.ingo@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fresh micro-lesions in cranial MRT (time frame: before and 72 h after CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2009.