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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569606
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Luzerner Kantonsspital
Information provided by (Responsible Party):
Donat R. Spahn, University of Zurich

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.

Condition or disease
Hemorrhage

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.

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Study Type : Observational
Actual Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Timeframe 2005 - 2007
Data of timeframe 2005 up to 2007 will be included
Timeframe 2012 - 2014
Data of timeframe 2012 up to 2014 will be included



Primary Outcome Measures :
  1. 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. [ Time Frame: up to 48 hours ]
    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.

  2. Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score. [ Time Frame: up to 48 hours ]
    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.


Secondary Outcome Measures :
  1. Comparison of the predicted mortality (TRISS/RISC2) with the actual rate [ Time Frame: up to 30 days ]
    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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569606


Locations
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Switzerland
Lucerne Kantonssital
Lucerne, Switzerland, 6000
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Donat R. Spahn
Luzerner Kantonsspital
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Responsible Party: Donat R. Spahn, Head of Institut of Anesthesiology University Hospital Zurich, University of Zurich
ClinicalTrials.gov Identifier: NCT02569606    
Other Study ID Numbers: ZH 2015 - 0309
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Keywords provided by Donat R. Spahn, University of Zurich:
consumption of blood
consumption of coagulation products
coagulation algorithm
trauma related transfusion
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes