Postoperative BloodlossMECCNCT01306903
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
A study testing MECC, MOPS and Super MOPS in people with Postoperative Bloodloss, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Bloodloss
- What is being tested?
- MECC, MOPS and Super MOPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jun 2013
- 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
- extracorporeal circulation
- age > 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation.
The aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.
- Conditions
- Postoperative Bloodloss
- Being tested
- MECC, MOPS, Super MOPS
- Keywords
- Minimizing Cardiopulmonary Bypass MECC damage organ failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MECCDevice
Minimized extracorporeal circulation
MOPSDevice
Modified and optimized perfusion system Frankfurt
Super MOPSDevice
Super modified and optimized perfusion system Frankfurt
| Study group | Role | What they receive |
|---|---|---|
| MECC | Experimental | Minimal extracorporeal circuit Receives: Device: MECC |
| MOPS | Placebo comparator | Not described Receives: Device: MOPS |
| Super MOPS | Placebo comparator | Not described Receives: Device: Super MOPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodloss
Count of red blood packages
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative BloodlossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital
- Investigators
- Arndt H Kiessling, MD, Principal investigator, Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306903
- Sponsor's protocol ID
- Mini-ECC001AHK
- Acronym
- MECC
- Status last verified
- Jun 2013
- First submitted
- 1 Mar 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
- ClinicalTrials.gov ID
- NCT01306903
- Acronym / sponsor ID
- MECC / Mini-ECC001AHK
- Conditions
- Postoperative Bloodloss
- Keywords
- Minimizing Cardiopulmonary Bypass MECC damage organ failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Mar 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 standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation.
The aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MECC | Experimental | Device: MECCMinimal extracorporeal circuit |
| MOPS | Placebo comparator | Device: MOPS |
| Super MOPS | Placebo comparator | Device: Super MOPS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- extracorporeal circulation
- age > 18 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MECCMinimized extracorporeal circulation | Device | MECC |
| MOPSModified and optimized perfusion system Frankfurt | Device | MOPS |
| Super MOPSSuper modified and optimized perfusion system Frankfurt | Device | Super MOPS |
Primary outcome
Bloodloss
Time frame: postoperative
Count of red blood packages
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 4 Jun 2013.
- Research THGLink provided by the sponsor.
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.
Arndt H Kiessling, MD principal investigator
Goethe University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MECC, MOPS and Super MOPS in people with Postoperative Bloodloss, run by Johann Wolfgang Goethe University Hospital at 1 site 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 2 inclusion and 0 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 4 Jun 2013. 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 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. Some participants in this study may receive a placebo. 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?
Bloodloss (time frame: postoperative). 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 4 Jun 2013.