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„Hämoglobinorientierter und gerinnungsfaktorbasierter Algorithmus“

Effekt auf Transfusionsbedarf und standardisierte Mortalitätsrate bei massivtransfusionspflichtigen Traumapatienten

Hemoglobin-oriented and coagulation factor-based algorithm

Effect on transfusion needs and standardized mortality rate in massively transfused trauma patients

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Zusammenfassung

Hintergrund

Blutungen sind eine der häufigsten vermeidbaren Todesursachen beim Trauma, die durch eine adäquate chirurgische Blutstillung, frühzeitige und ausreichende Gerinnungstherapie behandelt werden können.

Fragestellung

Konnten durch die Einführung einer frühen Standard Operating Procedure (SOP), die sich auf Gerinnungsfaktoren stützt und am im Schockraum bestimmten Hämoglobingehalt (SR-Hb) orientiert, eine Reduktion der standardisierten Mortalitätsrate (SMR, beobachtete Letalität: prognostizierte Letalität) und eine Reduktion des Transfusionsbedarfs bei Massivtransfusion(MT)-pflichtigen Traumapatienten erreicht werden?

Methode

Retrospektive, monozentrische Untersuchung an einem überregionalen Traumazentrum mithilfe eines „Vorher-Nachher“-Vergleichs im Zeitraum 2005–2014. Verglichen wurden die Kohorte der MT-pflichtigen Patienten vor Einführung einer „Gerinnung-SOP“ (Gruppe 1) und die Kohorte danach (Gruppe 2).

Ergebnisse

Von 952 versorgten Patienten benötigten 86 (9%) eine MT. Dabei entfielen 45 Patienten auf die Gruppe 1 und 41 Patienten auf die Gruppe 2. Beide Gruppen waren hinsichtlich Verletzungsschwere, im Schockraum erhobener Hämostaseparameter und Geschlechtsverteilung nahezu ähnlich. Jedoch zeigten sich signifikante Unterschiede in der Thrombozytenzahl bei Schockraumaufnahme (159 Gpt/l in Gruppe 1 vs. 124 Gpt/l in Gruppe 2) und in der nach Revised Injury Severity Classification (RISC) prognostizierten Letalität (46,5 % in Gruppe 1 vs. 65,3 % in Gruppe 2). Die SMR sank von 0,95 in Gruppe 1 auf 0,72 in Gruppe 2. Der Transfusionsbedarf an Erythrozyten in Gruppe 2 war signifikant niedriger, und wesentliche Hämostaseparameter bei Intensivaufnahme waren signifikant besser. Gruppe 2 erhielt signifikant häufiger gerinnungsaktive Substanzen.

Schlussfolgerung

Ein frühes, auf Gerinnungsfaktoren gestütztes standardisiertes Vorgehen in Form einer SOP führt zu einer signifikanten Reduktion des Transfusionsbedarfs an Erythrozytenkonzentraten (EK) und zu einem Trend, die SMR bei MT-pflichtigen Traumapatienten zu reduzieren.

Abstract

Background

Bleeding and trauma-induced coagulopathy (TIC) are major contributors to death related to trauma in the first 24 h and the major preventable contributors. Early surgical therapy and aggressive correction of TIC are key steps to prevent death in patients suffering from hemorrhage. Therefore, a standard operating procedure (SOP) using a hemoglobin (Hb)-oriented and coagulation factor-based algorithm for early correction of TIC was introduced in this level 1 trauma center. This SOP uses the correlation of the Hb values measured in the trauma bay and standard coagulation tests as the basis for various aggressive coagulation therapies.

Objective

The aim was to investigate the effectiveness of the SOP in trauma patients requiring massive transfusions. The main objective was the effect on the transfusion requirements and the standardized mortality ratio (SMR), the ratio of observed deaths to expected/predicted deaths, in the cohort of massively transfused trauma patients after introduction of the SOP compared with a historical cohort.

Method

A retrospective, single center study was carried out at a supraregional trauma center between 2005 and 2014. After introduction of the Hb-oriented, coagulation factor-based SOP for correction of TIC in 2011 a before/after comparison of all trauma patients requiring massive transfusions during trauma bay resuscitation and intensive care unit (ICU) admission was carried out. Main outcome parameters were the transfusion requirement and the SMR. The historical cohort of massively transfused trauma patients before introduction of the SOP (group 1) was compared with the cohort after introduction of the SOP (group 2). Furthermore, the two cohorts were compared regarding injury severity, expected death calculated with the revised injury severity classification (RISC), hemostatic results on trauma bay and ICU admission, clotting therapy and outcome.

Results

Of the 952 patients investigated 86 (9%) required massive transfusion (45 in group 1 and 41 in group 2). Both groups were comparable regarding injury severity but showed slight differences in hemostatic results on trauma bay admission, with a trend to worse results in group 2. Differences were recorded for platelet count on trauma bay admission with significantly lower values in group 2. The RISC predicted a significant difference in the mortality rate (46.5 % group 1 and 65.3 % group 2) but no significant differences in the observed mortality (44.4 % group 1 and 47 % group 2) were recorded. The SMR decreased from 0.95 in group 1 to 0.72 in group 2, meaning that in group 1 from 21 predicated trauma deaths 20 occurred and in group 2 from 27 predicated trauma deaths 19 occurred. This difference is not statistically significant (p = 0.16) due to the small sample size but is clinically relevant. A significant reduction in the requirement of red blood cell transfusions (22.8 ± 8.1 units vs 17.6 ± 7.6 units) was achieved (p = 0.003). Significant differences between the groups were observed regarding frequency and quantity of the coagulation-promoting drugs. Compared with group 1 the SOP used in group 2 achieved significantly better hemostatic results on ICU admission for fibrinogen and Quick’s value and a clear trend to better results for international normalized ratio (INR) and PTT.

Conclusion

The SOP based on coagulation factor values and standardized clotting therapy showed a clear trend to reduction of the SMR in massively transfused trauma patients. On the other hand the SOP achieved a significant reduction in the transfusion requirements and a significant improvement in the hemostatic results in the most severely injured patients. This can be interpreted as an effective use of coagulation factors in the early hospital treatment of trauma patients with ongoing bleeding.

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Authors and Affiliations

  1. Klinik für Anästhesiologie, Intensiv- u. Notfallmedizin, BG-Kliniken Bergmannstrost Halle (Saale), Merseburgerstr. 165, 06112, Halle (Saale), Deutschland

    P. Hilbert-Carius (D.E.A.A.) & R. Stuttmann PD Dr.

  2. Klinik für Unfall- u. Wiederherstellungschirurgie, BG-Kliniken Bergmannstrost Halle (Saale), Halle (Saale), Deutschland

    G. Hofmann Prof. Dr. Dr.

  3. Klinik für Unfall-, Hand- u. Wiederherstellungschirurgie, Friedrich-Schiller-Universität Jena, Jena, Deutschland

    G. Hofmann Prof. Dr. Dr.

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  1. P. Hilbert-Carius (D.E.A.A.)
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Correspondence to P. Hilbert-Carius (D.E.A.A.).

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Interessenkonflikt

P. Hilbert-Carius hat Vortragshonorare von CSL Behring erhalten. G. Hofmann und R. Stuttmann geben an, dass kein Interessenkonflikt besteht.

Alle im vorliegenden Manuskript beschriebenen Untersuchungen am Menschen wurden mit Zustimmung der zuständigen Ethik-Kommission (Ethikkommission der Ärztekammer Sachsen-Anhalt), im Einklang mit nationalem Recht sowie gemäß der Deklaration von Helsinki von 1975 (in der aktuellen, überarbeiteten Fassung) durchgeführt. Von allen beteiligten Patienten liegt eine Einverständniserklärung vor.

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Hilbert-Carius, P., Hofmann, G. & Stuttmann, R. „Hämoglobinorientierter und gerinnungsfaktorbasierter Algorithmus“. Anaesthesist 64, 828–838 (2015). https://doi.org/10.1007/s00101-015-0093-8

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