International Prospective Registry of Disseminated Intravascular Coagulation

Disseminated Intravascular Coagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577015
• Other study ID #: 184/2017
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Alessandro Squizzato, MD PhD
• Email: alessandro.squizzato[@]uninsurbia.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (7)

Lead Sponsor	Collaborator
Marcella Muller	Juntendo University, Manchester Royal Infirmary, Ospedale S. Antonio, Poliambulanza Foundation Hospital, Università degli Studi dell'Insubria, University of Chieti

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	mortality	mortality rates in patient who develop or do not develop disseminated intravascular coagulation	28 days
Secondary	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
Secondary	Arterial thromboembolic events	occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism	28 days
Secondary	Major and clinically-relevant non-major bleeding	occurence of major and clinically relevant non-major bleeding	28 days