International Prospective Registry of Disseminated Intravascular Coagulation

NCT03577015 | Unknown

• 1 other identifier: 184/2017
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Disseminated Intravascular Coagulation

Keywords

disseminated intravascular coagulation; sepsis; trauma; pancreatitis; malignancy; obstetric complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• mortality

  28 days

• venous thromboembolic events

  28 days

• Arterial thromboembolic events

  28 days

• Major and clinically-relevant non-major bleeding

  28 days

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• admission to the intensive care unit
• years or older
• AND one of the following conditions:
• sepsis/severe infection
• solid tumor
• hematological malignancy
• trauma
• obstetric complications
• acute pancreatitis

You may not qualify if:

• \<18 years

Sponsors & Collaborators

• Marcella Muller: lead
• Università degli Studi dell'Insubria: collaborator
• University of Chieti: collaborator
• Ospedale S. Antonio: collaborator
• Poliambulanza Foundation Hospital: collaborator
• Manchester Royal Infirmary: collaborator
• Juntendo University: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Disseminated Intravascular Coagulation; Sepsis; Wounds and Injuries; Pancreatitis; Neoplasms

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Sabrina Boraso, MD

  OSPEDALE S. ANTONIO, Padova, Italy

  PRINCIPAL INVESTIGATOR

• Marcello Di Nisio, MD PhD

  University of Chieti, Italy

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Alessandro Squizzato, MD PhD

CONTACT

alessandro.squizzato@uninsurbia.it

Marcella Muller, MD PhD

CONTACT

+31-20-5669111; m.c.muller@amc.uva.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 5, 2018
• Study Start: November 1, 2017
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

NL (1)