Trial document





This trial has been registered retrospectively.
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  DRKS00008090

Trial Description

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Title

Point of care coagulation-diagnostic in human sepsis

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Trial Acronym

POCSEP-Trial

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URL of the Trial

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Brief Summary in Lay Language

In this study the quality of Point of Care coagulation diagnostics (POC coagulation diagnostics) in the context of diagnosing sepsis is evaluated. Furthermore these methods (ROTEM Platelat®, Multiplate®) also give a detailed insight in the hemostasis of critically ill patients.

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Brief Summary in Scientific Language

Sepsis is still a challenge for every intensive care physician, not only in therapy but also in early diagnostics. In this study the quality of Point of Care coagulation diagnostics (POC coagulation diagnostics) in the context of diagnosing sepsis is evaluated. Furthermore these methods also give a detailed insight in the hemostasis of critically ill patients.
Background of this study is that recently two studies could show that markers of POC coagulation diagnostics can be of unexpected diagnostic value [1, 2]. Especially the clot lyse index (CLI) seems to be a promising diagnostic marker which may differentiate early between a sterile perioperative SIRS and sepsis. In this regard the CLI seems to be superior to the routine parameters (CRP, PCT, sCD14-ST, IL-6, etc). Moreover, the advantage of the CLI would be the possible bedside monitoring and thus a time advantage. In addition to the earlier detection of the indisposition itself this method also seems to be able to detect sepsis associated disseminated intravascular coagulation (DIC) at an earlier stage [1].
In these studies clear advantages were in fact shown, however single measurements lay 24 hours apart. This claims for closer-meshed measurements because especially during sepsis an early start of therapy determines the course of disease. This is why now for an explorative data analysis the time intervals directly after sepsis-onset shall be considerably reduced. Thus the aim is to show if these bedside monitoring methods are also able to function as diagnostic markers in very early stages of the disease. This would enable to treat patients with suspected sepsis even earlier and more specifically.

1.) Brenner, T., et al., Viscoelastic and aggregometric point-of-care testing in patients with septic shock - cross-links between inflammation and haemostasis. Acta Anaesthesiol Scand. 56(10): p. 1277-90.
2.) Adamzik, M., et al., Comparison of thromboelastometry with procalcitonin, interleukin 6, and C-reactive protein as diagnostic tests for severe sepsis in critically ill adults. Crit Care. 14(5): p. R178.

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Organizational Data

  •   DRKS00008090
  •   2015/05/07
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  •   yes
  •   Approved
  •   S-247/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   A41 -  Other sepsis
  •   D65 -  Disseminated intravascular coagulation [defibrination syndrome]
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Interventions/Observational Groups

  •   Within the scope of this study the following parameters will be measured of 30 patients with severe sepsis or septic shock at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d: general laboratory Parameters (e.g. number of leukocytes, CRP, PCT etc.), IL-6 ROTEM, Multiplate, hemodynamics, breathing, blood gas, metabolics, balance and evaluation of the severity of disease by daily calculation of APACHE II-, SOFA-, SAPS- and DIC-Scores.
  •   Within the scope of this study the following parameters will be measured of 30 patients with a sterile SIRS, after a major abdominal surgery (e.g. whipple, hemihepatectomy, etc.) at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d: general laboratory Parameters (e.g. number of leukocytes, CRP, PCT etc.), IL-6, ROTEM, Multiplate, hemodynamics, breathing, blood gas, metabolics, balance and evaluation of the severity of disease by daily calculation of APACHE II-, SOFA-, SAPS- and DIC-Scores.
  •   Within the scope of this study the following parameters will be measured of 30 healthy probands at one time point: general laboratory Parameters (e.g. number of leukocytes, CRP, PCT etc.), IL-6, ROTEM, Multiplate, and DIC-Scores.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

*Applicability of single parameters of the point of care coagulation diagnostics as early diagnostic markers in context of sepsis, as well as their correlation with established inflammatory markers at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d (CRP, PCT, IL-6, TNF-α).
*Evaluation of changes in hemostasis in course of major sepsis and septic shock with the aid of modern point of care coagulation diagnostics at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d.
*Search for a secure and early diagnosis parameter for sepsis associated coagulation dysfunction (DIC).

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Secondary Outcome

*Correlation of the severity of the coagulation dysfunction (assessment via an established scoring system = DIC score), the severity of disease (SOFA score, APACHE-II score, SAPS score), and the duration of stay in the intensive care unit at the time points onset, 3h, 6h, 12h, 24h, 48h, and 7d.
*Evaluation of the possible diagnostic time advantage of point of care coagulation diagnostics and the resulting earlier start of therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with Sepsis/ septic shock:
*Written consent form of study participant or his appointed representative
*Age > 18 years
*sepsis-criteria have to be fulfilled (Berlin definition 2012)
SIRS-patients:
*Written consent form of study participant or his appointed representative
*Age > 18 years
*Undergoing major abdominal surgery (e.g. whipple, hemihepatectomy, etc.)
Healthy-probands
*Written consent form of study participant or his appointed representative
*Age > 18 years
*no acute or chronical inflammatory disease

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Exclusion Criteria

*Non-fulfillment of inclusion criteria
*Status post recent cardiac surgery
*Status post recently suffered multiple trauma
*Patient whose therapy program includes tranexamic acid
*Refusal of participation in the study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Im Neuenheimer feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.