Rotational Thromboelastometry Versus DIC Score in Sepsis

NCT04610853 | Completed

• 1 other identifier: RODSS-2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; septic shock; disseminated intravascular coagulation; rotational thromboelastometry; DIC score

Outcome Measures

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

  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 Outcomes (1)

• correlation between ROTEM variables and the Sequential Organ Function Assessment Score

  through study completion, up to an average of 7 days

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with sepsis admitted to a medical intensive care unit

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Hospital of Leipzig

Leipzig, Saxony, D-04103, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Citrate plasma as a backup for coagulation profile

MeSH Terms

Conditions

Sepsis; Shock, Septic; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

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

Study Officials

• Sirak Petros, MD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: November 2, 2020
• Study Start: November 2, 2020
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

DE (1)