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Brief Title: International Prospective Registry of Disseminated Intravascular Coagulation
Official Title: International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit
Study ID: NCT03577015
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Academic Medical Center, Amsterdam, , Netherlands
Name: Sabrina Boraso, MD
Affiliation: OSPEDALE S. ANTONIO, Padova, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Marcello Di Nisio, MD PhD
Affiliation: University of Chieti, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Jecko Tachil, MD PhD
Affiliation: Manchester Royal Infirmary, Manchester, England
Role: PRINCIPAL_INVESTIGATOR
Name: Pierluigi Ferretti, MD
Affiliation: Fondazione Poliambulanza, Brescia, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Toshiaki Iba, MD PhD
Affiliation: (Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan
Role: PRINCIPAL_INVESTIGATOR