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Spots Global Cancer Trial Database for International Prospective Registry of Disseminated Intravascular Coagulation

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Trial Identification

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

Interventions

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Academic Medical Center, Amsterdam, , Netherlands

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

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