Coagulation and Hemorrhagic DisordersNCT03642912
Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation (Observational Study)
An observational study of Coagulation and Hemorrhagic Disorders and Extracorporeal Membrane Oxygenation Complication, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation and Hemorrhagic Disorders, Extracorporeal Membrane Oxygenation Complication
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2019to 31 Dec 2022
- 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: critically ill patients treated with ECMO
Who may be able to join
- patient treated on ICU of Department of Anesthesiology of LMU Munich
- treated with ECMO
- age >/= 18 years (adult patients only)
- informed consent
Who cannot join
- underage patients
- pregnant patients
- hemoglobin level < 8mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation Hämostaseologisches Monitoring Bei Patienten Mit Extrakorporaler Membranoxygenierung
Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich.
Read the detailed description
Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich. Adult ECMO patients are included in the study after informed consent.
Bleeding and thromboembolic complications as well as treatment details are recorded. Additional coagulation laboratory markers (such as von-Willebrand-factor, ADAMTS13-protease, platelet function tests and thromboelastometric tests) are correlated with clinical signs of bleeding. Regular ultrasound examination of the large vessels are performed to Screen for thrombosis.
- Keywords
- ECMO, haemostasis, coagulation, haemostatic alterations
- Medical subject headings
- Thrombosis, Hemorrhagic Disorders
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 |
|---|---|---|
| ECMO patients | ECMO patients treated on the intensive care units of the Department of Anesthesiology of LMU Munich |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet function parameter
platelet function test
Measured: after starting ECMO therapy - up to 28 days after starting ECMO therapy
platelet function parameter
platelet function test
Measured: one week after ending ECMO therapy
coagulation parameter
thromboelastometric test
Measured: after starting ECMO therapy - up to 28 days after starting ECMO therapy
coagulation parameter
thromboelastometric test
Measured: one week after ending ECMO therapy
Secondary outcomes (2)
inflammatory parameter
bradykinin levels
Measured: after starting ECMO therapy - up to 28 days after starting ECMO therapy
inflammatory parameter
bradykinin levels
Measured: one week after ending ECMO therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start16 Jan 2019
- Primary completion30 Sep 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation and Hemorrhagic DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Zoller MD, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Zoller, MD, Principal investigator, Department of Anaesthesiology, LMU MunichMathias Bruegel, MD, Principal investigator, Institute of Laboratory Medicine, LMU MunichDominik J Hoechter, MD, Study director, Department of Anaesthesiology, LMU MunichMichael Weigand, MD, Study director, Institute of Laboratory Medicine, LMU MunichBernhard Zwißler, MD, Prof., Study chair, Department of Anaesthesiology, LMU MunichDaniel Teupser, MD, Prof., Study chair, Institute of Laboratory Medicine, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642912
- Sponsor's protocol ID
- LMU 18-047
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Monitoring in Patients on Extracorporeal Membrane Oxygenation Hämostaseologisches Monitoring Bei Patienten Mit Extrakorporaler Membranoxygenierung
- ClinicalTrials.gov ID
- NCT03642912
- Acronym / sponsor ID
- LMU 18-047
- Keywords
- ECMO, haemostasis, coagulation, haemostatic alterations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich.
Detailed description
Coagulation disorders are on top of the list of extracorporeal-membrane oxygenation (ECMO) complications. They contribute significantly to morbidity and mortality of ECMO patients. This observational study aims to evaluate coagulation profiles of ECMO patients treated on the intensive care units of the Department of Anaesthesiology of LMU Munich. Adult ECMO patients are included in the study after informed consent.
Bleeding and thromboembolic complications as well as treatment details are recorded. Additional coagulation laboratory markers (such as von-Willebrand-factor, ADAMTS13-protease, platelet function tests and thromboelastometric tests) are correlated with clinical signs of bleeding. Regular ultrasound examination of the large vessels are performed to Screen for thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO patients | – | –ECMO patients treated on the intensive care units of the Department of Anesthesiology of LMU Munich |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients treated with ECMO
Key inclusion criteria (4 listed)
- patient treated on ICU of Department of Anesthesiology of LMU Munich
- treated with ECMO
- age >/= 18 years (adult patients only)
- informed consent
Key exclusion criteria (3 listed)
- underage patients
- pregnant patients
- hemoglobin level < 8mg/dl
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
platelet function parameter
Time frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
platelet function test
platelet function parameter
Time frame: one week after ending ECMO therapy
platelet function test
coagulation parameter
Time frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
thromboelastometric test
coagulation parameter
Time frame: one week after ending ECMO therapy
thromboelastometric test
2 secondary outcomes
inflammatory parameter
Time frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy
inflammatory parameter
Time frame: one week after ending ECMO therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No. sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)
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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 Zoller, MD principal investigator
Department of Anaesthesiology, LMU Munich
Mathias Bruegel, MD principal investigator
Institute of Laboratory Medicine, LMU Munich
Dominik J Hoechter, MD study director
Department of Anaesthesiology, LMU Munich
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 Coagulation and Hemorrhagic Disorders and Extracorporeal Membrane Oxygenation Complication, run by Ludwig-Maximilians - University of Munich 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 4 inclusion and 3 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 6 Apr 2022. 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?
Results are not available in the source record.
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?
platelet function parameter (time frame: after starting ECMO therapy - up to 28 days after starting ECMO therapy). The study lists 4 primary outcomes in all. 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 6 Apr 2022.