International Prospective Registry of Disseminated Intravascular Coagulation

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria

  collaborator OTHER

• University of Chieti

  collaborator OTHER

• Ospedale S. Antonio

  collaborator UNKNOWN

• Poliambulanza Foundation Hospital

  collaborator UNKNOWN

• Manchester Royal Infirmary

  collaborator UNKNOWN

• Juntendo University

  collaborator OTHER

• Marcella Muller

  lead OTHER

Principal Investigators

• Sabrina Boraso, MD · OSPEDALE S. ANTONIO, Padova, Italy

• Marcello Di Nisio, MD PhD · University of Chieti, Italy

• Jecko Tachil, MD PhD · Manchester Royal Infirmary, Manchester, England

• Pierluigi Ferretti, MD · Fondazione Poliambulanza, Brescia, Italy

• Toshiaki Iba, MD PhD · (Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2021-04-01

Completion

2021-06-01

Countries

• Netherlands

Study Locations