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

NCT02569606 | Completed

• 1 other identifier: ZH 2015 - 0309
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhage

Keywords

consumption of blood; consumption of coagulation products; coagulation algorithm; trauma related transfusion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Comparison of the predicted mortality (TRISS/RISC2) with the actual rate

  up to 30 days

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• incomplete data
• denial of informed consent

Sponsors & Collaborators

• Donat R. Spahn: lead
• Luzerner Kantonsspital: collaborator

Study Sites (2)

Lucerne Kantonssital

Lucerne, 6000, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Institut of Anesthesiology University Hospital Zurich

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 7, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

CH (2)