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

NCT ID: NCT02569606

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Timeframe 2005 - 2007

Data of timeframe 2005 up to 2007 will be included

No interventions assigned to this group

Timeframe 2012 - 2014

Data of timeframe 2012 up to 2014 will be included

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role collaborator

Donat R. Spahn

OTHER

Sponsor Role lead

Responsible Party

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Donat R. Spahn

Head of Institut of Anesthesiology University Hospital Zurich

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lucerne Kantonssital

Lucerne, , Switzerland

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ZH 2015 - 0309

Identifier Type: -

Identifier Source: org_study_id

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