Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm

Hemorrhage Clinical Trial

Official title:

Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569606
• Other study ID #: ZH 2015 - 0309
• Status: Completed
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Locations

Country	Name	City	State
Switzerland	Lucerne Kantonssital	Lucerne
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Donat R. Spahn	Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The coagulation algorithm was launched in 2010. To show the difference in transfusion and administration of coagulation products prior and after the changes of coagulation algorithm the probability of massive transfusion (TASH Score) will be compared with the actual rate. The TASH Score is the most precise predictive probability of a massive transfusion. Data of approximately 1800 participants will be compared.	up to 48 hours
Primary	Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.	Massive transfusion (>10 units of blood) can be predicted on the base of patient and trauma epidemiology. The investigator compares the actual rate in the institution with the rate predicted by the score.	up to 48 hours
Secondary	Comparison of the predicted mortality (TRISS/RISC2) with the actual rate	TRISS is a common Score and is a comparative value for trauma mortality outcome. The investigators want to show the benefit of launched coagulation algorithm in mortality after severe trauma.	up to 30 days