Clinical trial NCT03577015: International Prospective Registry of Disseminated Intravascular Coagulation
Official title: International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disseminated Intravascular Coagulation
Keywords: disseminated intravascular coagulation
sepsis
trauma
pancreatitis
malignancy
obstetric complication
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
name: University of Chieti
name: Ospedale S. Antonio
name: Poliambulanza Foundation Hospital
name: Manchester Royal Infirmary
name: Juntendo University
First posted: 2018-07-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: disseminated intravascular coagulation
timeFrame: 28 days
measure: disseminated intravascular coagulation
timeFrame: 28 days
Secondary outcomes:
measure: mortality
timeFrame: 28 days
measure: venous thromboembolic events
timeFrame: 28 days
measure: Arterial thromboembolic events
timeFrame: 28 days
measure: Major and clinically-relevant non-major bleeding
timeFrame: 28 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: OSPEDALE S. ANTONIO, Padova, Italy
name: Sabrina Boraso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chieti, Italy
name: Marcello Di Nisio, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester Royal Infirmary, Manchester, England
name: Jecko Tachil, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Poliambulanza, Brescia, Italy
name: Pierluigi Ferretti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: (Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan
name: Toshiaki Iba, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: