International Prospective Registry of Disseminated Intravascular Coagulation

Study Overview
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Brief Summary
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Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry. Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis. Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days. Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.

Official Title
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International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit

Conditions
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Disseminated Intravascular Coagulation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admission to the intensive care unit 18 years or older AND one of the following conditions: sepsis/severe infection solid tumor hematological malignancy trauma obstetric complications acute pancreatitis Exclusion Criteria: -<18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| critically ill patients at risk for DIC<br>patients 18 years or older with a condition potentially associated with DIC, admitted to intensive care: severe infection/sepsis, solid tumor, hematologic malignancies, trauma, obstetric complications, acute pancreatitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disseminated intravascular coagulation | occurence of disseminated intravascular coagulation: International Society Thrombosis Hemostasis DIC score >4 points (range 0-8 points) items scored: platelet count, prothrombin time, fibrinogen related marker, fibrinogen level Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products | 28 days | 
| disseminated intravascular coagulation | occurence of disseminated intravascular coagulation: Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality rates in patient who develop or do not develop disseminated intravascular coagulation | 28 days | 
| venous thromboembolic events | occurence of symptomatic venous thromboembolic events including pulmonary embolism and deep vein thrombosis (VTE) of the upper and lower limbs, visceral VTE, and cerebral VTE. | 28 days | 
| Arterial thromboembolic events | occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism | 28 days | 
| Major and clinically-relevant non-major bleeding | occurence of major and clinically relevant non-major bleeding | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disseminated intravascular coagulation, sepsis, trauma, pancreatitis, malignancy, obstetric complication