Clinical trial · Observational
International Prospective Registry of Disseminated Intravascular Coagulation
International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disseminated Intravascular Coagulation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- critically ill patients at risk for DIC
- description
- 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 outcomes (2)
- measure
- disseminated intravascular coagulation
- timeFrame
- 28 days
- description
- 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
- measure
- disseminated intravascular coagulation
- timeFrame
- 28 days
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available