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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Academic Medical Center
Amsterdam, Netherlands
RECRUITINGdisseminated 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
Time frame: 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
Time frame: 28 days
mortality
mortality rates in patient who develop or do not develop disseminated intravascular coagulation
Time frame: 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.
Time frame: 28 days
Arterial thromboembolic events
occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism
Time frame: 28 days
Major and clinically-relevant non-major bleeding
occurence of major and clinically relevant non-major bleeding
Time frame: 28 days
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