Disseminated Intravascular Coagulation
Conditions
Keywords
disseminated intravascular coagulation, sepsis, trauma, pancreatitis, malignancy, obstetric complication
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.
Interventions
None listed
Sponsors
Università degli Studi dell'Insubria
University of Chieti
Ospedale S. Antonio
Poliambulanza Foundation Hospital
Manchester Royal Infirmary
Juntendo University
Marcella Muller
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disseminated intravascular coagulation | 28 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 28 days | mortality rates in patient who develop or do not develop disseminated intravascular coagulation |
| venous thromboembolic events | 28 days | 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. |
| Arterial thromboembolic events | 28 days | occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism |
| Major and clinically-relevant non-major bleeding | 28 days | occurence of major and clinically relevant non-major bleeding |
Countries
Netherlands
Contacts
Primary ContactAlessandro Squizzato, MD PhD
Backup ContactMarcella Muller, MD PhD
Outcome results
None listed