ClinicalTrials.Veeva

Menu

Rotational Thromboelastometry Versus DIC Score in Sepsis (RODSS)

U

University of Leipzig

Status

Completed

Conditions

Septic Shock
Sepsis

Treatments

Diagnostic Test: rotational thromboelastometry

Study type

Observational

Funder types

Other

Identifiers

NCT04610853
RODSS-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

Loading...

Central trial contact

Sirak Petros, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems