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2017-11-01
2021-04-01
2021-06-01
1000
NCT03577015
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OBSERVATIONAL
International Prospective Registry of Disseminated Intravascular Coagulation
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-22 | N/A | 2018-08-10 |
2018-07-02 | N/A | 2018-08-13 |
2018-07-05 | N/A | 2018-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| mortality | mortality rates in patient who develop or do not develop disseminated intravascular coagulation | 28 days |
| 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 |
| Arterial thromboembolic events | occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism | 28 days |
| Major and clinically-relevant non-major bleeding | occurence of major and clinically relevant non-major bleeding | 28 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Alessandro Squizzato, MD PhD Phone Number: Email: alessandro.squizzato@uninsurbia.it |
Study Contact Backup Name: Marcella Muller, MD PhD Phone Number: +31-20-5669111 Email: m.c.muller@amc.uva.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
