Clinical trial NCT04610853: Rotational Thromboelastometry Versus DIC Score in Sepsis
Official title: Rotational Thromboelastometry Versus The Disseminated Intravascular Coagulation Score in Sepsis (RODSS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Keywords: sepsis
septic shock
disseminated intravascular coagulation
rotational thromboelastometry
DIC score
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with sepsis admitted to a medical intensive care unit

Brief summary: Sepsis results in activation of the coagulation system, which is commonly described as disseminated intravascular coagulation (DIC). The DIC score, which is commonly used to define this syndrome, does not allow to delineate between hypercoagulation and hypocoagulation. The aim of this prospective observational study is to evaluate data from automated rotational thromboelastometry and compare These with the DIC score regarding intensive care unit outcome.

Detailed description: Sepsis results in an intensive interaction between Inflammation and the coagulation system. The activation of the coagulation system leads to consumption of procoagulatory as well as anticoagulatory proteins and platelets. This process may induce microcirculatory thrombosis as well as hemorrhagic diathesis, which is commonly described as disseminated intravascular coagulation (DIC).

The International Society on Thrombosis and Haemostasis (ISTH) recommends the use of the DIC score to describe this syndrome. A score of at least 5 points is defined as an overt DIC. However, the DIC score does not allow to differentiate between a hypercoagulation and hypocoagulation states and whether there could be a difference regarding outcome between the two states.

In this prospective observational study, patients admitted to a medical intensive care unit will be included. The DIC score as well as rotational thromboelastometry (ROTEM) will be evaluated within the first 24 hours after the diagnosis of sepsis as well as on day 3 and 5.

Eligibility criteria: Inclusion Criteria:

* Sepsis, defined according to the Sepsis-3 Definition
* informed consent

Exclusion Criteria:

* age \<18 years
* pregnancy and lactation
* known coagulation disorder prior to Admission for sepsis
* known cirrhosis of the liver
* known active malignancy
* surgical procedure during the last 4 weeks
* refusal to participate in the study

Primary outcomes:
measure: Correlation between the clotting time, clot formation time, maximum clot firmness and lysis index at 30 minutes from FIBTEM, INTEM, EXTEM and APTEM measurements of the ROTEM assay with an overt DIC on the day of sepsis diagnosis regarding ICU survival
timeFrame: through study completion, up to an average of 7 days
Secondary outcomes:
measure: correlation between ROTEM variables and the Sequential Organ Function Assessment Score
timeFrame: through study completion, up to an average of 7 days
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Hospital of Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Sirak Petros, MD
role: PRINCIPAL_INVESTIGATOR
References: