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Rotational Thromboelastometry Versus DIC Score in Sepsis (RODSS)

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ClinicalTrials.gov Identifier: NCT04610853
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sirak Petros, MD, University of Leipzig

Study Description
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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
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
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Study Type : Observational
Estimated 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 : November 2, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Citrate plasma as a backup for coagulation profile

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients with sepsis admitted to a medical intensive care unit
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610853


Contacts
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Contact: Sirak Petros, MD +49 341 9712700 sirak.petros@medizin.uni-leipzig.de

Locations
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Germany
University Hospital of Leipzig Recruiting
Leipzig, Saxony, Germany, D-04103
Contact: Sirak Petros, MD    3419712700 ext ++49    sirak.petros@medizin.uni-leipzig.de   
Contact: Lorenz Weidhase, MD    3419712480 ext ++49    lorenz.weidhase@medizin.uni-leipzig.de   
Sub-Investigator: Kevin Kunz, MD         
Sub-Investigator: Frank Seidel, MD         
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Sirak Petros, MD University of Leipzig
More Information
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Responsible Party: Sirak Petros, MD, Professor, University of Leipzig
ClinicalTrials.gov Identifier: NCT04610853    
Other Study ID Numbers: RODSS-2020
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sirak Petros, MD, University of Leipzig:
sepsis
septic shock
disseminated intravascular coagulation
rotational thromboelastometry
DIC score
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Disseminated Intravascular Coagulation
Infections
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Shock
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia