Clinical trial NCT02569606: Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Official title: Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: consumption of blood
consumption of coagulation products
coagulation algorithm
trauma related transfusion
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
First posted: 2015-10-07
Enrollment: 1800
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All trauma patients with an injury severity score (ISS) \>15 treated in University Hospital Zurich or Lucerne hospital during 2005 to 2007 and 2012 to 2014

Brief summary: Comparison of the consumption of blood and coagulation products (packed red blood cells, fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates, coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics) before and after the introduction of a designated trauma related transfusion and coagulation algorithm.The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Two level-1 trauma centers in Switzerland (Hospital Lucerne, University Hospital Zurich) are included in the study. Predicted probability of a massive transfusion by the trauma associated acute hemorrhage score (TASH)is correlated with the actual rate.

Detailed description: Trauma is one of the leading causes of death worldwide. After death due to direct craniofacial injury, exsanguination is the next major cause for trauma mortality.

After initial pre-hospital treatment the patient is admitted to the hospital. If multiple injuries are present the patient is transferred to a specialized trauma center.

Besides surgical treatment, the patient needs stabilization of the vital functions by the Anesthesiologist. Due to loss of blood volume, dilution of the circulatory blood volume and pathological activation of coagulation/fibrinolysis, trauma induced coagulopathy (TIC) is initiated. This needs to be treated and avoided whenever possible.

Transfusion of allogeneic blood and coagulation product itself leads to an increased morbidity and mortality. Infectious and immunologic reactions account for that phenomenon.

This led to a paradigm change in the therapy of TIC. In 2009 a new coagulation factor based coagulation algorithm was introduced in the Hospital Lucerne and the University Hospital in Zurich / Switzerland. With the help of point of care coagulation measurement, tailored coagulation factor based coagulation management and avoidance of allogeneic blood products was initiated.

The investigators now want to analyze the impact of the coagulation algorithm by comparing the periods before and after the introduction of the algorithm.

The consumption of blood and coagulation products (packed red blood cells, fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates, coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics) before and after the introduction of a designated trauma related transfusion and coagulation algorithm will be recorded and compared. The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Predicted probability of a massive transfusion by the TASH score (trauma associated acute hemorrhage) is correlated with the actual rate.

Eligibility criteria: Inclusion Criteria:

* male and female trauma patients
* admitted to the University hospital of Zurich or the Hospital of Lucerne, Switzerland
* injury severity score \>= 16
* time period 2005-2007 and 2012-2014

Exclusion Criteria:

* incomplete data
* denial of informed consent

Primary outcomes:
measure: Comparison the consumption of red blood cells, fresh frozen plasma and platelets in the treatment period by the Anaesthesist and after 24/48 hours before (2005-2007) and after (2012-2014) launching the coagulation algorithm.
timeFrame: up to 48 hours
measure: Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.
timeFrame: up to 48 hours
Secondary outcomes:
measure: Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Lucerne Kantonssital
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References: