TraumaTICAFNCT03572309
Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen
An observational study of Trauma and Hemorrhage, run by Masaryk University at 1 site in Czechia.
Trial summary
The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trauma, Hemorrhage, Coagulopathy
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 19 Jun 2018to 1 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult trauma patients with severe trauma admitted to emergency departement of university hospital who recieved fibrinogen during prehospital care.
Who may be able to join
- multiple trauma, injury severity score (ISS) ≥16
- administration of fibrinogen in prehospital care
- age 18-80 years
Who cannot join
- ISS 75
- pregnancy
- therapeutic anticoagulation
- therapeutic antiaggregation
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Brno and Masaryk University Brno
Brno, 62500
About this study
The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.
Read the detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department during the study will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. In addition, 28-day mortality and the incidence of thromboembolic complications will be monitored.
- Conditions
- Trauma, Hemorrhage, Coagulopathy
- Keywords
- trauma induced coagulopathy, multiple trauma, fibrinogen
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Hemostatic Disorders, Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Trauma induced coagulopathy
Incidence of trauma induced coagulopathy
Measured: day of enrolment
Secondary outcomes (2)
28day mortality
Measured: 28 days after enrolment
thromboembolic complications
Measured: 28 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start19 Jun 2018
- Primary completion4 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies 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
- 30 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, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572309
- Sponsor's protocol ID
- CT0022018
- Acronym
- TICAF
- Status last verified
- May 2025
- First submitted
- 19 Jun 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vrbica K, Keller F, Stingl J, Vanickova K, Stepanova R, Dolecek M, Hrdy O, Gal R. Incidence of ROTEM(R)-defined coagulopathy at hospital arrival among polytrauma patients receiving fibrinogen concentrate in prehospital setting: a prospective observational study. Eur J Trauma Emerg Surg. 2026 Apr 24;52(1):144. doi: 10.1007/s00068-026-03183-8.
PubMed 42030009
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
- Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen
- ClinicalTrials.gov ID
- NCT03572309
- Acronym / sponsor ID
- TICAF / CT0022018
- Conditions
- Trauma, Hemorrhage, Coagulopathy
- Keywords
- trauma induced coagulopathy, multiple trauma, fibrinogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 28 Jun 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.
The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.
Detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department during the study will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. In addition, 28-day mortality and the incidence of thromboembolic complications will be monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult trauma patients with severe trauma admitted to emergency departement of university hospital who recieved fibrinogen during prehospital care.
Key inclusion criteria (3 listed)
- multiple trauma, injury severity score (ISS) ≥16
- administration of fibrinogen in prehospital care
- age 18-80 years
Key exclusion criteria (4 listed)
- ISS 75
- pregnancy
- therapeutic anticoagulation
- therapeutic antiaggregation
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
Trauma induced coagulopathy
Time frame: day of enrolment
Incidence of trauma induced coagulopathy
2 secondary outcomes
28day mortality
Time frame: 28 days after enrolment
thromboembolic complications
Time frame: 28 days after enrolment
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.
- Derived from this study: PubMed 42030009Vrbica K, Keller F, Stingl J, Vanickova K, Stepanova R, Dolecek M, Hrdy O, Gal R. Incidence of ROTEM(R)-defined coagulopathy at hospital arrival among polytrauma patients receiving fibrinogen concentrate in prehospital setting: a prospective observational study. Eur J Trauma Emerg Surg. 2026 Apr 24;52(1):144. doi: 10.1007/s00068-026-03183-8.
- 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
Masaryk University
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 Trauma and Hemorrhage, 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 3 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?
Trauma induced coagulopathy (time frame: day of enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572309, which also lists 1 linked publication.
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.