Sepsis - to Reduce Mortality in the Intensive Care UnitROSTICNCT06891599
ROTEM in Sepsis Trauma Outcome in Intensive Care
An observational study of Sepsis - to Reduce Mortality in the Intensive Care Unit and Trauma Coagulopathy, run by Region Stockholm at 1 site in Sweden.
Trial summary
This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis - to Reduce Mortality in the Intensive Care Unit, Trauma Coagulopathy
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients in Stockhiolm Region
Who may be able to join
- Trauma patients:
- Trauma alarm activated at hospital admission New Injury Severity Score (NISS) > 15 Transfer to hospital within 7 days of trauma with NISS > 15
- Sepsis patients:
- Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission
- Control group:
- Patients undergoing elective surgery without expected coagulopathy
Who cannot join
- Trauma patients:
- Isolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age <18 years
- Sepsis patients:
- Age <18 years
- Control patients:
- Ongoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)
This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.
- Keywords
- Sepsis, ROTEM, Trauma, Coagulopathy
- Medical subject headings
- Sepsis, Wounds and Injuries, Hemostatic 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 |
|---|---|---|
| Trauma | Trauma alarm activated at hospital admission New Injury Severity Score (NISS) > 15 Transfer to hospital within 7 days of trauma with NISS > 15 | |
| Sepsis | Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission | |
| Control | Patients undergoing elective surgery without expected coagulopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis - to Reduce Mortality in the Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891599
- Sponsor's protocol ID
- 2022-07157-01
- Other IDs
- FoUI-985360
- Acronym
- ROSTIC
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, individual participant data (IPD) will not be shared due to privacy concerns, ethical considerations, and regulatory restrictions. The study involves sensitive patient data, including coagulation profiles and clinical outcomes, which are subject to strict data protection laws and institutional guidelines within Region Stockholm. Additionally, data will be pseudoanonymized and stored on secure research servers, with access limited to the study team. While aggregate results will be published in peer-reviewed journals, sharing of raw IPD requires specific ethical and legal approvals, which are not currently in place for unrestricted access. However, data access requests for collaborative research may be considered on a case-by-case basis, subject to approval by the relevant ethics committees and data protection authorities.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)
- ClinicalTrials.gov ID
- NCT06891599
- Acronym / sponsor ID
- ROSTIC / 2022-07157-01
- Keywords
- Sepsis, ROTEM, Trauma, Coagulopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trauma | – | –Trauma alarm activated at hospital admission New Injury Severity Score (NISS) > 15 Transfer to hospital within 7 days of trauma with NISS > 15 |
| Sepsis | – | –Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission |
| Control | – | –Patients undergoing elective surgery without expected coagulopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in Stockhiolm Region
Key inclusion criteria (6 listed)
- Trauma alarm activated at hospital admission New Injury Severity Score (NISS) > 15 Transfer to hospital within 7 days of trauma with NISS > 15
- Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission
- Patients undergoing elective surgery without expected coagulopathy
Key exclusion criteria (6 listed)
- Isolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age <18 years
- Age <18 years
- Ongoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age <18 years
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
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
Time frame: Through study completion, an average of 2 years
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Undecided. At this time, individual participant data (IPD) will not be shared due to privacy concerns, ethical considerations, and regulatory restrictions. The study involves sensitive patient data, including coagulation profiles and clinical outcomes, which are subject to strict data protection laws and institutional guidelines within Region Stockholm. Additionally, data will be pseudoanonymized and stored on secure research servers, with access limited to the study team. While aggregate results will be published in peer-reviewed journals, sharing of raw IPD requires specific ethical and legal approvals, which are not currently in place for unrestricted access. However, data access requests for collaborative research may be considered on a case-by-case basis, subject to approval by the relevant ethics committees and data protection authorities.
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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.
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 Sepsis - to Reduce Mortality in the Intensive Care Unit and Trauma Coagulopathy, run by Region Stockholm at 1 site in Sweden.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattias Günther, MD PhD (+46812361000, mattias.gunther@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients (time frame: Through study completion, an average of 2 years). 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 24 Mar 2025.