International Prospective Registry of Disseminated Intravascular Coagulation

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

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.

Study Overview

• Status: Unknown
• Conditions: Disseminated Intravascular Coagulation

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Alessandro Squizzato, MD PhD; Email: alessandro.squizzato@uninsurbia.it
• Study Contact Backup: Name: Marcella Muller, MD PhD; Phone Number: +31-20-5669111; Email: m.c.muller@amc.uva.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Academic Medical Center
    • Contact: Marcella Muller, MD PhD; Email: m.c.muller@amc.uva.nl
    • Contact: Nicole Juffermans, MD PhD; Email: n.p.juffermans@amc.uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients 18 years or older with a condition potentially associated with DIC, admitted to the intensive care unit, will be eligible for the study. The maximal time-window allowed between the diagnosis of the disease and inclusion in the study will be 72 hours.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
critically ill patients at risk for DIC; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disseminated intravascular coagulation	occurence of disseminated intravascular coagulation: International Society Thrombosis Hemostasis DIC score >4 points (range 0-8 points) items scored: platelet count, prothrombin time, fibrinogen related marker, fibrinogen level Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products	28 days
disseminated intravascular coagulation	occurence of disseminated intravascular coagulation: Japanese Association for Acute Medicine DIC score >3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality rates in patient who develop or do not develop disseminated intravascular coagulation	28 days
venous thromboembolic events	occurence of symptomatic venous thromboembolic events including pulmonary embolism and deep vein thrombosis (VTE) of the upper and lower limbs, visceral VTE, and cerebral VTE.	28 days
Arterial thromboembolic events	occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism	28 days
Major and clinically-relevant non-major bleeding	occurence of major and clinically relevant non-major bleeding	28 days

Collaborators and Investigators

• Sponsor: Marcella Muller
• Collaborators: Università degli Studi dell'Insubria; Juntendo University; University of Chieti; Ospedale S. Antonio; Poliambulanza Foundation Hospital; Manchester Royal Infirmary
• Investigators: Principal Investigator: Sabrina Boraso, MD, OSPEDALE S. ANTONIO, Padova, Italy; Principal Investigator: Marcello Di Nisio, MD PhD, University of Chieti, Italy; Principal Investigator: Jecko Tachil, MD PhD, Manchester Royal Infirmary, Manchester, England; Principal Investigator: Pierluigi Ferretti, MD, Fondazione Poliambulanza, Brescia, Italy; Principal Investigator: Toshiaki Iba, MD PhD, (Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: trauma; sepsis; pancreatitis; malignancy; disseminated intravascular coagulation; obstetric complication
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemorrhagic Disorders; Blood Coagulation Disorders; Thrombophilia; Disseminated Intravascular Coagulation
• Other Study ID Numbers: 184/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No