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

11. mai 2018 oppdatert av: Donat R. Spahn
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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1800

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Lucerne, Sveits, 6000
        • Lucerne Kantonssital
      • Zurich, Sveits, 8091
        • University Hospital Zurich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Retrospektiv

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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.
up to 48 hours
Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.
Tidsramme: 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.
up to 48 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
Tidsramme: 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.
up to 30 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Donat R. Spahn

Samarbeidspartnere

Luzerner Kantonsspital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2015

Primær fullføring (Faktiske)

1. september 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

30. september 2015

Først innsendt som oppfylte QC-kriteriene

2. oktober 2015

Først lagt ut (Anslag)

7. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ZH 2015 - 0309

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