International Prospective Registry of Disseminated Intravascular Coagulation

NCT ID: NCT03577015

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Disseminated Intravascular Coagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role collaborator

University of Chieti

OTHER

Sponsor Role collaborator

Ospedale S. Antonio

UNKNOWN

Sponsor Role collaborator

Poliambulanza Foundation Hospital

UNKNOWN

Sponsor Role collaborator

Manchester Royal Infirmary

UNKNOWN

Sponsor Role collaborator

Juntendo University

OTHER

Sponsor Role collaborator

Marcella Muller

OTHER

Sponsor Role lead

Responsible Party

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Marcella Muller

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sabrina Boraso, MD

Role: PRINCIPAL_INVESTIGATOR

OSPEDALE S. ANTONIO, Padova, Italy

Marcello Di Nisio, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chieti, Italy

Jecko Tachil, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester Royal Infirmary, Manchester, England

Pierluigi Ferretti, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Poliambulanza, Brescia, Italy

Toshiaki Iba, MD PhD

Role: PRINCIPAL_INVESTIGATOR

(Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan

Locations

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Academic Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Alessandro Squizzato, MD PhD

Role: CONTACT

Marcella Muller, MD PhD

Role: CONTACT

+31-20-5669111

Facility Contacts

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Marcella Muller, MD PhD

Role: primary

Nicole Juffermans, MD PhD

Role: backup

Other Identifiers

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184/2017

Identifier Type: -

Identifier Source: org_study_id

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