- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132208
Evaluation of the TICCS Capacity to Identify Trauma Patients With Acute Coagulopathy and Massive Bleeding
Pre-hospital Identification of Trauma Patients With Early Acute Coagulopathy and Massive Bleeding: Results of a Prospective Non-interventional Clinical Trial Evaluating the Trauma Induced Coagulopathy Clinical Score (TICCS).
A prospective single-centre non-comparative non-interventional open study has been designed to validate, in a target number of 100 trauma patients, the correlation between TICCS evaluated on the site of injury and thromboelastography made on a whole blood sample taken at the latest 30 min after patient's arrival in the resuscitation room.
The aim of this study was to evaluate the capacity to discriminate trauma patients suffering from active bleeding and arly acute coagulopathy of trauma and needing Damage control resuscitation from those without this aggravating combination with a new purely clinical easy-to-measure pre-hospital score: the Trauma Induced Coagulopathy Clinical Score (TICCS).
Study Overview
Status
Detailed Description
It started in January 2012 and was completed in June 2013. The TICCS was to be calculated for each patient. The presence of coagulopathy was to be assessed by thromboelastography measured at the latest 30 minutes after patient's hospital entry or, if not available, by standard coagulation tests (International Normalized Ratio or Prothrombin Time, activated partial thromboplastin time, fibrinogen, platelets).
Haemorrhagic shock was to be assessed by the treating physician at hospital entry on the basis of persistent hypotension due to a demonstrated active bleeding.
Surgical procedures and transfusion needs (up to 24 hours) were to be recorded all along patients' hospitalization. The transfusion of more than 4 Red Blood Cells units and more than 3 Fresh Frozen Plasma units within the first hour of care was defined as a massive transfusion.
We defined two populations of patients. "Severe" patients were defined by associating all the following conditions: active bleeding + early acute coagulopathy of trauma + need for massive transfusion + need for emergent surgical or endovascular hemostasis; "non-severe" patients were defined as patients without this 4-conditions association. Patients meeting only three of the four criteria or less were thus recorded as "non-severe".
Quantitative variables were summarized as mean, standard deviation (SD) and range, while frequency tables were used for categorical findings. The cut-off value for TICCS was obtained by Receiver Operating Characteristic curve analysis based on the severity of the patients. Group comparisons were done by Student t-test for continuous variables and by the chi-square test (or Fisher exact test) for categorical variables. Each trauma score was characterized by its sensitivity, specificity, positive and negative predicted values and area under the curve (AUC). Results were considered significant at the 5% critical level (P<0.05). Calculations were performed with the Statistical Analyses System statistical package for Windows (version 9.3).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Liège, Belgium, 4000
- Centre Hospitalier Régional de la Citadelle
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Every trauma patients admitted in our resuscitation
Exclusion Criteria:
- age under 12
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Trauma
Severe trauma patients admitted in the resuscitation room of our emergency department.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Thromboelastometric evaluation on whole blood sample
Time Frame: baseline
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baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of blood products transfused
Time Frame: up to 24 hours
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up to 24 hours
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Other Outcome Measures
Outcome Measure |
Time Frame |
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International normalized ratio
Time Frame: baseline
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baseline
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fibrinogen level
Time Frame: baseline
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baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Martin L Tonglet, MD, CHR de la Citadelle, Liège, Belgium
Publications and helpful links
General Publications
- Tonglet ML, Poplavsky JL, Seidel L, Minon JM, D'Orio V, Ghuysen A. Thromboelastometry in trauma care: a place in the 2018 Belgian health care system? Acta Clin Belg. 2018 Aug;73(4):244-250. doi: 10.1080/17843286.2017.1422311. Epub 2018 Jan 4.
- Tonglet ML, Minon JM, Seidel L, Poplavsky JL, Vergnion M. Prehospital identification of trauma patients with early acute coagulopathy and massive bleeding: results of a prospective non-interventional clinical trial evaluating the Trauma Induced Coagulopathy Clinical Score (TICCS). Crit Care. 2014 Nov 26;18(6):648. doi: 10.1186/s13054-014-0648-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRcitadelle-trauma-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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