RODSS: Rotational Thromboelastometry Versus DIC Score in Sepsis

Sponsor

University of Leipzig (Other)

Overall Status

Recruiting

CT.gov ID

NCT04610853

Collaborator

(none)

100

Enrollment

Location

30.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Septic Shock	Diagnostic Test: rotational thromboelastometry

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Rotational Thromboelastometry Versus The Disseminated Intravascular Coagulation Score in Sepsis (RODSS)

Actual Study Start Date :

Nov 2, 2020

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Outcome Measures

Primary Outcome Measures

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 [through study completion, up to an average of 7 days]
The ICU survival of patients with abnormal clotting time, clot formation time, maximum clot firmness or lysis index at 30 minutes from FIBTEM, INTEM, EXTEM and APTEM of the ROTEM assay will be compared to that of patients with an overt DIC according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH)

Secondary Outcome Measures

correlation between ROTEM variables and the Sequential Organ Function Assessment Score [through study completion, up to an average of 7 days]
The Sequential Organ Function Assessment (SOFA) score of patients with any abnormal ROTEM variable will be compared to the score of patients without any abnormal ROTEM variable