International Prospective Registry of Disseminated Intravascular Coagulation

• Conditions: Disseminated Intravascular Coagulation

• Registration Number: NCT03577015
• Lead Sponsor: Marcella Muller

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disseminated intravascular coagulation	28 days	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

Secondary Outcome Measures

Name	Time	Method
Arterial thromboembolic events	28 days	occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism
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.
Major and clinically-relevant non-major bleeding	28 days	occurence of major and clinically relevant non-major bleeding

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands