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Rotational Thromboelastometry Versus DIC Score in Sepsis

NCT ID: NCT04610853

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-02

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis Septic Shock

Keywords

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sepsis septic shock disseminated intravascular coagulation rotational thromboelastometry DIC score

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Sirak Petros, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirak Petros, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

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University Hospital of Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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RODSS-2020

Identifier Type: -

Identifier Source: org_study_id