Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Università degli Studi dell'Insubria | OTHER |
| University of Chieti | OTHER |
| Ospedale S. Antonio | UNKNOWN |
| Poliambulanza Foundation Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| 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 |
| 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. |
Not provided
Inclusion Criteria:
AND one of the following conditions:
Exclusion Criteria:
-<18 years
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Squizzato, MD PhD | Contact | alessandro.squizzato@uninsurbia.it | ||
| Marcella Muller, MD PhD | Contact | +31-20-5669111 | m.c.muller@amc.uva.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sabrina Boraso, MD | OSPEDALE S. ANTONIO, Padova, Italy | Principal Investigator |
| Marcello Di Nisio, MD PhD | University of Chieti, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Recruiting | Amsterdam | 1105 AZ | Netherlands |
Not provided
| ID | Term |
|---|---|
| D004211 | Disseminated Intravascular Coagulation |
| D018805 | Sepsis |
| D014947 | Wounds and Injuries |
| D010195 | Pancreatitis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| UNKNOWN |
| Manchester Royal Infirmary | UNKNOWN |
| Juntendo University | OTHER |
Not provided
Not provided
Not provided
| 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 |
| Jecko Tachil, MD PhD |
| Manchester Royal Infirmary, Manchester, England |
| Principal Investigator |
| Pierluigi Ferretti, MD | Fondazione Poliambulanza, Brescia, Italy | Principal Investigator |
| Toshiaki Iba, MD PhD | (Juntendo University, Department of Emergency and Disaster Medicine, Tokyo, Japan | Principal Investigator |
| D019851 | Thrombophilia |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |