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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| correlation between ROTEM variables and the Sequential Organ Function Assessment Score | 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 | through study completion, up to an average of 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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patients with sepsis admitted to a medical intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Sirak Petros, MD | University of Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Leipzig | Leipzig | Saxony | D-04103 | Germany |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D004211 | Disseminated Intravascular Coagulation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Citrate plasma as a backup for coagulation profile
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D019851 | Thrombophilia |