NCT03577015

International Prospective Registry of Disseminated Intravascular Coagulation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Marcella Muller · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disseminated Intravascular Coagulation

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2018-07-05
• Last updated: 2018-08-13

Locations

1 site across 1 country: Netherlands