Point of care coagulation-diagnostic in human sepsis

Point of care coagulation-diagnostic in human sepsis - POCSEP-Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00008090

Enrollment

120

Registered

2015-05-07

Start date

2014-11-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41 D65

Interventions

Group 1: 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 lab

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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-a). 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).	—

Measure

Time frame

*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-a). *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).

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

*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.

—

Countries

Germany

Contacts

Public ContactFelix Carl Fabian Schmitt

Universitätsklinikum HeidelbergKlinik für Anästhesiologie

felix.schmitt@med.uni-heidelberg.de06221-56-39421

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 4, 2026