PolytraumaROTCLOTNCT04107818
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
An observational study of Polytrauma and Coagulation Disorder, run by Masaryk University at 1 site in Czechia.
Trial summary
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polytrauma, Coagulation Disorder
- How many people
- 108 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Nov 2019to 13 Oct 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
- Adult, Older adult
Study population: Adult patients admitted to emnergency department for severe trauma.
Who may be able to join
- age ≥18 years
- polytrauma with Injury severity score ≥ 16
Who cannot join
- pregnancy
- anticoagulant therapy
- antiplatelet therapy
- coagulation disorders
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Brno and Masaryk University Brno
Brno, 62500
About this study
Official title: Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
Read the detailed description
The study will commence following approval by the Research Ethics Committee. All patients admitted to the emergency department for trauma from October 1, 2019, to January 31, 2020, will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested.
Viscoelastic coagulation tests will be performed simultaneously using ROTEM® Delta and ClotPro®. The investigators will compare the values of clotting time (CT), clot formation time (CFT), alpha angle, maximum clot firmness (MCF), and maximum lysis (ML) obtained from the extrinsic pathway test (EX-test) on ClotPro® with those obtained from the extrinsic pathway test (EXTEM) on ROTEM® Delta.
Furthermore, the investigators will compare the values of clotting time (CT), clot formation time (CFT), alpha angle, maximum clot firmness (MCF), and maximum lysis (ML) obtained from the fibrinogen test (FIB-test) on ClotPro® with those obtained from fibrinogen thromboelastometry (FIBTEM) on ROTEM® Delta.
The secondary outcome will be to assess the relationship between measurement results and patient temperature.
Study data will be entered into a study form. Measurements may be repeated over time. The indication for subsequent measurements will be determined solely by the treating physician.
Differences in estimated viscoelastic coagulation parameters and the interchangeability of the two devices will be analysed.
- Conditions
- Polytrauma, Coagulation Disorder
- Keywords
- polytrauma, coagulopathy, viscoelastic tests
- Medical subject headings
- Multiple Trauma, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotting time (CT) in EX-test and EXTEM
difference in clotting time measured by EX-test and EXTEM
Measured: through study completion, an average of 3 months
Clot formation time (CFT) in EX-test and EXTEM
difference in clot formation time measured by EX-test and EXTEM
Measured: through study completion, an average of 3 months
alfa angle in EX-test and EXTEM
difference in alfa angle measured by EX-test and EXTEM
Measured: through study completion, an average of 3 months
maximum clot firmness (MCF) in EX-test and EXTEM
difference in maximum clot firmness measured by EX-test and EXTEM
Measured: through study completion, an average of 3 months
maximum lysis (ML) in EX-test and EXTEM
maximum lysis difference in MCF measured by EX-test and EXTEM
Measured: through study completion, an average of 3 months
clotting time (CT) FIB-test and FIBTEM
difference in clotting time measured by FIB-test and FIBTEM
Measured: through study completion, an average of 3 months
clot formation time (CFT) FIB-test and FIBTEM
difference in clot formation time measured by FIB-test and FIBTEM
Measured: through study completion, an average of 3 months
maximum clot firmness (MCF) FIB-test and FIBTEM
difference in maximum clot firmness measured by FIB-test and FIBTEM
Measured: through study completion, an average of 3 months
alfa angle FIB-test and FIBTEM
difference in alfa angle measured by FIB-test and FIBTEM
Measured: through study completion, an average of 3 months
maximum lysis (ML) FIB-test and FIBTEM
difference in maximum lysis measured by FIB-test and FIBTEM
Measured: through study completion, an average of 3 months
Secondary outcomes (3)
patient temperature
effect of patients´ temperature on results of measurements
Measured: through study completion, an average of 3 months
maximum clot firmness (MCF) FIB-test and Clauss method
correlation of maximum clot firmness with blod fibrinogen level
Measured: through study completion, an average of 3 months
maximum clot firmness (MCF) FIBTEM and Clauss method
correlation of maximum clot firmness with blod fibrinogen level
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start21 Nov 2019
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolytraumaStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Roman Gal, MD., PhD., Study chair, University Hospital Brno and Masaryk University Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107818
- Sponsor's protocol ID
- CT0022019
- Acronym
- ROTCLOT
- Status last verified
- May 2024
- First submitted
- 9 Aug 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04107818
- Acronym / sponsor ID
- ROTCLOT / CT0022019
- Conditions
- Polytrauma, Coagulation Disorder
- Keywords
- polytrauma, coagulopathy, viscoelastic tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 27 Sep 2019 (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.
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
Detailed description
The study will commence following approval by the Research Ethics Committee. All patients admitted to the emergency department for trauma from October 1, 2019, to January 31, 2020, will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested.
Viscoelastic coagulation tests will be performed simultaneously using ROTEM® Delta and ClotPro®. The investigators will compare the values of clotting time (CT), clot formation time (CFT), alpha angle, maximum clot firmness (MCF), and maximum lysis (ML) obtained from the extrinsic pathway test (EX-test) on ClotPro® with those obtained from the extrinsic pathway test (EXTEM) on ROTEM® Delta.
Furthermore, the investigators will compare the values of clotting time (CT), clot formation time (CFT), alpha angle, maximum clot firmness (MCF), and maximum lysis (ML) obtained from the fibrinogen test (FIB-test) on ClotPro® with those obtained from fibrinogen thromboelastometry (FIBTEM) on ROTEM® Delta.
The secondary outcome will be to assess the relationship between measurement results and patient temperature.
Study data will be entered into a study form. Measurements may be repeated over time. The indication for subsequent measurements will be determined solely by the treating physician.
Differences in estimated viscoelastic coagulation parameters and the interchangeability of the two devices will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to emnergency department for severe trauma.
Key inclusion criteria (2 listed)
- age ≥18 years
- polytrauma with Injury severity score ≥ 16
Key exclusion criteria (4 listed)
- pregnancy
- anticoagulant therapy
- antiplatelet therapy
- coagulation disorders
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
Clotting time (CT) in EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in clotting time measured by EX-test and EXTEM
Clot formation time (CFT) in EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in clot formation time measured by EX-test and EXTEM
alfa angle in EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in alfa angle measured by EX-test and EXTEM
maximum clot firmness (MCF) in EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in maximum clot firmness measured by EX-test and EXTEM
maximum lysis (ML) in EX-test and EXTEM
Time frame: through study completion, an average of 3 months
maximum lysis difference in MCF measured by EX-test and EXTEM
clotting time (CT) FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in clotting time measured by FIB-test and FIBTEM
clot formation time (CFT) FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in clot formation time measured by FIB-test and FIBTEM
maximum clot firmness (MCF) FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in maximum clot firmness measured by FIB-test and FIBTEM
alfa angle FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in alfa angle measured by FIB-test and FIBTEM
maximum lysis (ML) FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in maximum lysis measured by FIB-test and FIBTEM
3 secondary outcomes
patient temperature
Time frame: through study completion, an average of 3 months
maximum clot firmness (MCF) FIB-test and Clauss method
Time frame: through study completion, an average of 3 months
maximum clot firmness (MCF) FIBTEM and Clauss method
Time frame: through study completion, an average of 3 months
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Roman Gal, MD., PhD. study chair
University Hospital Brno and Masaryk University Brno
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 Polytrauma and Coagulation Disorder, run by Masaryk University at 1 site in Czechia.
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 4 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 16 Oct 2026. 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 Czechia. 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?
Clotting time (CT) in EX-test and EXTEM (time frame: through study completion, an average of 3 months). The study lists 10 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 16 Oct 2026.