Disseminated Intravascular CoagulationNCT04356144
Thrombomodulin-modified Thrombin Generation Assay (TGA-TM) in Patients With Critical Infections
An observational study of Disseminated Intravascular Coagulation and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disseminated Intravascular Coagulation, Critical Illness, Sars-CoV2
- What is being tested?
- Thrombin Generation Assay (TGA) and Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)
- How many people
- 58 participants
- Where
- 1 siteAustria
- Study dates
- 15 Apr 2020to 1 Feb 2021
- 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: 60 critically ill patients with signs of infection with SARS-CoV2 or proven infection with SARS-CoV-2 admitted to Intensive Care Units (ICU).
Who may be able to join
- Admission to ICU
- Clinical signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2
- Neutrophil-Lymphocyte Ratio (NLR) >3
Who cannot join
- Intake of oral anticoagulants or any kind of parenteral therapeutic anticoagulation prior to ICU admission
- Congenital coagulation disorder
- Treatment with Prothrombin complex concentrate (F. II, VII, IX, X) or activated Prothrombin complex within past 48 hours
- Treatment with recombinant factor VIIa (e.g. eptacog alfa) within past 48 hours
- Treatment with recombinant protein C within past 48 hours
- Active bleeding
Show all 10Show fewer
- Acute myocardial infarction
- HIV infection
- Chronic pancreatitis
- Liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)
Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
- Conditions
- Disseminated Intravascular Coagulation, Critical Illness, Sars-CoV2, Viral Infection, Coagulation Disorder, Blood, Covid19
- Being tested
- Thrombin Generation Assay (TGA), Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)
- Keywords
- TGA, thrombin generation, Sars-CoV2, ROTEM, rotational thromboelastometry, viscoelastic assay, thrombomodulin
- Medical subject headings
- Disseminated Intravascular Coagulation, Critical Illness, Virus Diseases, Blood Coagulation Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombin Generation Assay (TGA)Diagnostic test
TGA via a fluorimetric module. Coagulation cascade is activated upon addition of different concentrations of tissue factor and phospholipids. The fluorogenic substrate Z-Gly-Gly-Arg-AMC (ZGGR-AMC) is cleaved by formed thrombin over time. By plotting the changes in fluorescence as a function of time (cnt/min), it depicts the "Thrombin Generation Curve" (thrombin generated - plotted against time). The area under the thrombin curve is defined as the endogenous thrombin potential (ETP).
Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)Diagnostic test
Recombinant Human Thrombomodulin (TM) is added to the conventional TGA. When recombinant TM is added, the protein C system is fully activated and therefore the ETP obtained reflects both the anti- and procoagulant factors.
| Study group | Role | What they receive |
|---|---|---|
| Critical infection | Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU Receives: Diagnostic Test: Thrombin Generation Assay (TGA); Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETP (AUC) without rhThrombomodulin (rhTM)
nM;
Measured: 6 months
ETP (AUC) with rhThrombomodulin (rhTM)
nM;
Measured: 6 months
ETP-ratio
Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measured: 6 months
ETP-Normalisation
Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start15 Apr 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated Intravascular CoagulationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Scientific Fund of the Mayor of Vienna
- Responsible party
- Principal investigator, Lukas Infanger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356144
- Sponsor's protocol ID
- TGA-TM-Critical-2019
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)
- ClinicalTrials.gov ID
- NCT04356144
- Acronym / sponsor ID
- TGA-TM-Critical-2019
- Conditions
- Disseminated Intravascular Coagulation, Critical Illness, Sars-CoV2, Viral Infection, Coagulation Disorder, Blood, Covid19
- Keywords
- TGA, thrombin generation, Sars-CoV2, ROTEM, rotational thromboelastometry, viscoelastic assay, thrombomodulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Medical Scientific Fund of the Mayor of Vienna
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 22 Apr 2020 (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.
Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical infection | – | Diagnostic Test: Thrombin Generation Assay (TGA), Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 critically ill patients with signs of infection with SARS-CoV2 or proven infection with SARS-CoV-2 admitted to Intensive Care Units (ICU).
Key inclusion criteria (3 listed)
- Admission to ICU
- Clinical signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2
- Neutrophil-Lymphocyte Ratio (NLR) >3
Key exclusion criteria (10 listed)
- Intake of oral anticoagulants or any kind of parenteral therapeutic anticoagulation prior to ICU admission
- Congenital coagulation disorder
- Treatment with Prothrombin complex concentrate (F. II, VII, IX, X) or activated Prothrombin complex within past 48 hours
- Treatment with recombinant factor VIIa (e.g. eptacog alfa) within past 48 hours
- Treatment with recombinant protein C within past 48 hours
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 |
|---|---|---|
| Thrombin Generation Assay (TGA)TGA via a fluorimetric module. Coagulation cascade is activated upon addition of different concentrations of tissue factor and phospholipids. The fluorogenic substrate Z-Gly-Gly-Arg-AMC (ZGGR-AMC) is cleaved by formed thrombin over time. By plotting the changes in fluorescence as a function of time (cnt/min), it depicts the "Thrombin Generation Curve" (thrombin generated - plotted against time). The area under the thrombin curve is defined as the endogenous thrombin potential (ETP). | Diagnostic test | Critical infection |
| Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)Recombinant Human Thrombomodulin (TM) is added to the conventional TGA. When recombinant TM is added, the protein C system is fully activated and therefore the ETP obtained reflects both the anti- and procoagulant factors. | Diagnostic test | Critical infection |
Primary outcome
ETP (AUC) without rhThrombomodulin (rhTM)
Time frame: 6 months
nM;
ETP (AUC) with rhThrombomodulin (rhTM)
Time frame: 6 months
nM;
ETP-ratio
Time frame: 6 months
Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
ETP-Normalisation
Time frame: 6 months
Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
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 23 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disseminated Intravascular Coagulation and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
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 10 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 23 Mar 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 Austria. 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?
ETP (AUC) without rhThrombomodulin (rhTM) (time frame: 6 months). 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 23 Mar 2021.