Rotational Thromboelastometry Versus DIC Score in Sepsis

Sepsis Clinical Trial

— RODSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610853
• Other study ID #: RODSS-2020
• Status: Recruiting
• Start date: November 2, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2023
• Source: University of Leipzig
• Contact: Sirak Petros, MD
• Phone: +49 341 9712700
• Email: sirak.petros[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation
• Sepsis
• Septic Shock
• Shock, Septic
• Toxemia

Intervention

Diagnostic Test:
• rotational thromboelastometry
ROTEM will be conducted and DIC score calculated within 24 hours after the diagnosis of Sepsis as well as on day 3 and 5 of ICU stay

Locations

Country	Name	City	State
Germany	University Hospital of Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	through study completion, up to an average of 7 days
Secondary	correlation between ROTEM variables and the Sequential Organ Function Assessment Score	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	through study completion, up to an average of 7 days