Trauma, MultipleSIDENCT02619539
Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
An observational study of Trauma, Multiple, run by Masaryk Hospital Krajská zdravotní a.s. at 2 sites in Czechia.
Trial summary
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Multiple
- What is being tested?
- plasma fibrinogen measurement
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 2 sitesCzechia
- Study dates
- Jan 2016to 28 Feb 2017
- How long will I take part?
- 1 Day
- 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: Patient having / suspected to have severe trauma admitted to participating centres.
Who may be able to join
- patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations
Who cannot join
- possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy)
- administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level
- circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
University Hospital in Plzen
Pilsen
Masaryk Hospital in Usti nad Labem
Ústí nad Labem, 40001
About this study
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.
Read the detailed description
Hypofibrinogenemia is common in severe trauma and below the threshold of 2.3 g/l is associated with increased mortality. Although guidelines for management of the trauma induced coagulopathy does not recommend any specific timing of fibrinogen substitution, several papers suggest that early substitution might be associated with improved outcome. Laboratory measurement of plasma fibrinogen level, thromboelastometry and/or its estimation based on base excess, hemoglobin level, Injury Severity Score or combinations require diagnostic procedures that are associated with with a certain time delay and prolongs the time to fibrinogen substitution.
- Conditions
- Trauma, Multiple
- Being tested
- plasma fibrinogen measurement
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma fibrinogen measurementProcedure or surgery
plasma fibrinogen measurement
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | All patients having / suspected to have severe trauma injuries admitted to participating centers. Receives: Procedure: plasma fibrinogen measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trauma, MultipleStudies 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
- 280 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Krajská zdravotní a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josef Skola, Masaryk Hospital Krajská zdravotní a.s.
- Investigators
- Josef Skola, Dr., Principal investigator, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619539
- Sponsor's protocol ID
- KAPIM-1
- Acronym
- SIDE
- Status last verified
- Mar 2017
- First submitted
- 30 Nov 2015
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, Roislien J, Eken T, Naess PA, Gaarder C. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014 Mar 26;18(2):R52. doi: 10.1186/cc13798.
PubMed 24666991Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685.
PubMed 23601765Levy JH, Szlam F, Tanaka KA, Sniecienski RM. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg. 2012 Feb;114(2):261-74. doi: 10.1213/ANE.0b013e31822e1853. Epub 2011 Sep 29.
PubMed 21965371Schochl H, Maegele M, Solomon C, Gorlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012 Feb 24;20:15. doi: 10.1186/1757-7241-20-15.
PubMed 22364525Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schochl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013 Jul 12;17(4):R137. doi: 10.1186/cc12816.
PubMed 23849249
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
- ClinicalTrials.gov ID
- NCT02619539
- Acronym / sponsor ID
- SIDE / KAPIM-1
- Conditions
- Trauma, Multiple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Masaryk Hospital Krajská zdravotní a.s.University, hospital or other
- Study start
- Jan 2016
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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.
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.
Detailed description
Hypofibrinogenemia is common in severe trauma and below the threshold of 2.3 g/l is associated with increased mortality. Although guidelines for management of the trauma induced coagulopathy does not recommend any specific timing of fibrinogen substitution, several papers suggest that early substitution might be associated with improved outcome. Laboratory measurement of plasma fibrinogen level, thromboelastometry and/or its estimation based on base excess, hemoglobin level, Injury Severity Score or combinations require diagnostic procedures that are associated with with a certain time delay and prolongs the time to fibrinogen substitution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | – | Procedure: plasma fibrinogen measurementAll patients having / suspected to have severe trauma injuries admitted to participating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having / suspected to have severe trauma admitted to participating centres.
Key inclusion criteria (1 listed)
- patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations
Key exclusion criteria (3 listed)
- possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy)
- administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level
- circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)
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 |
|---|---|---|
| plasma fibrinogen measurementplasma fibrinogen measurement | Procedure or surgery | Trauma patients |
Primary outcome
Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.
Time frame: On admission
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 24 Mar 2017.
- Background: PubMed 24666991Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, Roislien J, Eken T, Naess PA, Gaarder C. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014 Mar 26;18(2):R52. doi: 10.1186/cc13798.
- Background: PubMed 23601765Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685.
- Background: PubMed 21965371Levy JH, Szlam F, Tanaka KA, Sniecienski RM. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg. 2012 Feb;114(2):261-74. doi: 10.1213/ANE.0b013e31822e1853. Epub 2011 Sep 29.
- Background: PubMed 22364525Schochl H, Maegele M, Solomon C, Gorlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012 Feb 24;20:15. doi: 10.1186/1757-7241-20-15.
- Background: PubMed 23849249Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schochl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013 Jul 12;17(4):R137. doi: 10.1186/cc12816.
- 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.
Josef Skola, Dr. principal investigator
Masaryk Hospital Usti nad Labem
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Multiple, run by Masaryk Hospital Krajská zdravotní a.s. at 2 sites 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 1 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: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1. (time frame: On admission). 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 NCT02619539, which also lists 5 linked publications.
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 2017.