International Prospective Registry of Disseminated Intravascular Coagulation

Marcella Muller

Status: Unknown

Conditions: Disseminated Intravascular Coagulation

Study type: Observational

Funder types: Other

Identifiers

NCT03577015

184/2017

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

critically ill patients at risk for DIC

Description:

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