Disorder of Circulatory SystemNCT02352805
Coagulopathy and SIRS During ECC in Intensive Care
An observational study of Disorder of Circulatory System, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and circulatory support devices under intensive care conditions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Disorder of Circulatory System
- What is being tested?
- ECLS/ECC
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2015to 28 Nov 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients undergoing implantation of extracorporeal circulation or mechanical circulatory support systems (ECLS / ECMO / LVAD / dialysis) due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases. * Patients undergoing cardiac surgery with extracorporeal circulation (ECC).
Who may be able to join
- Need for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases
Who cannot join
- History of previously diagnosed hereditary coagulation and/or platelet disorders
- Refusal to receive blood transfusion
- Participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization
- Diagnosis of hepatitis B, hepatitis C, and HIV
- Age > 85 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen
Tübingen, 72076
About this study
Official title: A Comparative Clinical Study to Understand the Coagulopathy and Systemic Inflammation Associated With the Use of Extracorporeal Circulation in Intensive Care Patients
This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and circulatory support devices under intensive care conditions.
Read the detailed description
The complex interplay between the various factors contributing to the ECC-related coagulopathy and inflammation in intensive care settings is only poorly understood so far. Furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which anticoagulants may be employed to decrease complications associated with specific ECC systems. Therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy varies between different ECC systems and intensive care units.
A better understanding of the mechanisms of the activation and interaction of platelets and leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight starting-points to increase the safety and efficacy of ECC in intensive care medicine. The investigation of these phenomena in different ECC systems under clinical conditions is therefore the goal of this study.
In order to achieve the study goal, we will investigate cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different ECC systems under intensive care conditions.
- Conditions
- Disorder of Circulatory System
- Being tested
- ECLS/ECC
- Keywords
- Extracorporeal circulation, ventricular assist device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECLS/ECCDevice
Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| (1) veno-venous ECMO | ECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO) Receives: Device: ECLS/ECC | |
| (2) veno-arterial ECLS | ECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS) Receives: Device: ECLS/ECC | |
| (3) LVAD (Heart Mate II) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II) Receives: Device: ECLS/ECC | |
| (4) LVAD (Heart Ware) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware) Receives: Device: ECLS/ECC | |
| (5) LVAD (Impella) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella) Receives: Device: ECLS/ECC | |
| (6) Dialysis system | Patients being connected to a dialysis system Receives: Device: ECLS/ECC | |
| (7) LVAD (Heart Mate III) | LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III) Receives: Device: ECLS/ECC | |
| (8) HLM | HLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass Receives: Device: ECLS/ECC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of the platelet activation marker "beta-thromboglobulin"
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start30 Jan 2015
- Primary completion10 Jun 2020
- Study completion28 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Circulatory SystemStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Häberle, MD, Principal investigator, University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352805
- Sponsor's protocol ID
- COSIMA
- Status last verified
- Apr 2021
- First submitted
- 28 Jan 2015
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Study to Understand the Coagulopathy and Systemic Inflammation Associated With the Use of Extracorporeal Circulation in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT02352805
- Acronym / sponsor ID
- COSIMA
- Conditions
- Disorder of Circulatory System
- Keywords
- Extracorporeal circulation, ventricular assist device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 30 Jan 2015 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 2 Feb 2015 (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.
This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and circulatory support devices under intensive care conditions.
Detailed description
The complex interplay between the various factors contributing to the ECC-related coagulopathy and inflammation in intensive care settings is only poorly understood so far. Furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which anticoagulants may be employed to decrease complications associated with specific ECC systems. Therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy varies between different ECC systems and intensive care units.
A better understanding of the mechanisms of the activation and interaction of platelets and leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight starting-points to increase the safety and efficacy of ECC in intensive care medicine. The investigation of these phenomena in different ECC systems under clinical conditions is therefore the goal of this study.
In order to achieve the study goal, we will investigate cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different ECC systems under intensive care conditions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| (1) veno-venous ECMO | – | Device: ECLS/ECCECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO) |
| (2) veno-arterial ECLS | – | Device: ECLS/ECCECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS) |
| (3) LVAD (Heart Mate II) | – | Device: ECLS/ECCLVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II) |
| (4) LVAD (Heart Ware) | – | Device: ECLS/ECCLVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware) |
| (5) LVAD (Impella) | – | Device: ECLS/ECCLVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella) |
| (6) Dialysis system | – | Device: ECLS/ECCPatients being connected to a dialysis system |
| (7) LVAD (Heart Mate III) | – | Device: ECLS/ECCLVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III) |
| (8) HLM | – | Device: ECLS/ECCHLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients undergoing implantation of extracorporeal circulation or mechanical circulatory support systems (ECLS / ECMO / LVAD / dialysis) due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases. * Patients undergoing cardiac surgery with extracorporeal circulation (ECC).
Key inclusion criteria (1 listed)
- Need for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases
Key exclusion criteria (5 listed)
- History of previously diagnosed hereditary coagulation and/or platelet disorders
- Refusal to receive blood transfusion
- Participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization
- Diagnosis of hepatitis B, hepatitis C, and HIV
- Age > 85 years
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 |
|---|---|---|
| ECLS/ECCExtracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery | Device | (1) veno-venous ECMO, (2) veno-arterial ECLS, (3) LVAD (Heart Mate II), (4) LVAD (Heart Ware), (5) LVAD (Impella), (6) Dialysis system, (7) LVAD (Heart Mate III), (8) HLM |
Primary outcome
Plasma concentration of the platelet activation marker "beta-thromboglobulin"
Time frame: 48 hours
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 29 Apr 2021.
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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.
Helene Häberle, MD principal investigator
University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany
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 Disorder of Circulatory System, run by University Hospital Tuebingen 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 1 inclusion and 5 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 29 Apr 2021. 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. 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?
Plasma concentration of the platelet activation marker "beta-thromboglobulin" (time frame: 48 hours). 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 29 Apr 2021; AzTrials last refreshed its copy on 3 Nov 2026.