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Completed

NCT Number: NCT04610853

Rotational Thromboelastometry Versus DIC Score in Sepsis

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.

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Key information

Conditions

Sepsis Blood Coagulation Disorders Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Leipzig

Leipzig, Saxony, D-04103, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotational thromboelastometry

Diagnostic Test

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

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. correlation between ROTEM variables and the Sequential Organ Function Assessment Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: RODSS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2020
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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