Evaluation of the TICCS Capacity to Identify Trauma Patients With Acute Coagulopathy and Massive Bleeding

Multiple Trauma Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132208
• Other study ID #: CHRcitadelle-trauma-01
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: May 6, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Centre Hospitalier Régional de la Citadelle
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Every trauma patients admitted in our resuscitation

Exclusion Criteria:

• age under 12

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Early Complication of Trauma
• Hemorrhage
• Hemostatic Disorders
• Massive Bleeding
• Multiple Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Régional de la Citadelle	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional de la Citadelle

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International normalized ratio		baseline	No
Other	fibrinogen level		baseline	No
Primary	Thromboelastometric evaluation on whole blood sample		baseline	No
Secondary	Number of blood products transfused		up to 24 hours	No