NCT03577015|Unknown
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Sponsor study identifier
observational
1,000
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
April 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2017
Actual (reported)May 22, 2018
Actual (reported)July 5, 2018
Actual (reported)April 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
mortality
28 days
venous thromboembolic events
28 days
Arterial thromboembolic events
28 days
Major and clinically-relevant non-major bleeding
28 days
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
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.
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Sabrina Boraso, MD
OSPEDALE S. ANTONIO, Padova, Italy
Marcello Di Nisio, MD PhD
University of Chieti, Italy
Jecko Tachil, MD PhD
Manchester Royal Infirmary, Manchester, England
Pierluigi Ferretti, MD
Fondazione Poliambulanza, Brescia, Italy
First Submitted
May 22, 2018
First Posted
July 5, 2018
Study Start
November 1, 2017
Actual (reported)Primary Completion
April 1, 2021
Estimated (date passed)The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
Contact the study team to confirm eligibility.
Toshiaki Iba, MD PhD
(Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2018
Record last verified: 2018-08
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