International Prospective Registry of Disseminated Intravascular Coagulation
NCT ID: NCT03577015
Last Updated: 2018-08-13
Study Results
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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UNKNOWN
1000 participants
OBSERVATIONAL
2017-11-01
2021-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* 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
ALL
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
University of Chieti
OTHER
Ospedale S. Antonio
UNKNOWN
Poliambulanza Foundation Hospital
UNKNOWN
Manchester Royal Infirmary
UNKNOWN
Juntendo University
OTHER
Marcella Muller
OTHER
Responsible Party
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Marcella Muller
Principal 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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184/2017
Identifier Type: -
Identifier Source: org_study_id
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