Wounds and Injuries

All Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Blood and Lymph Conditions

Heart and Blood Diseases

Pancreatitis

Sepsis

Toxemia

Disseminated Intravascular Coagulation

Hemostatic Disorders

Blood Coagulation Disorders

Hematologic Diseases

Hemorrhagic Disorders

Thrombophilia

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

Alessandro Squizzato, MD PhD

Marcella Muller, MD PhD

Nicole Juffermans, MD PhD

Sabrina Boraso, MD

Marcello Di Nisio, MD PhD

Jecko Tachil, MD PhD

Pierluigi Ferretti, MD

Toshiaki Iba, MD PhD

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.

International Prospective Registry of Disseminated Intravascular Coagulation

International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit

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

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

mortality rates in patient who develop or do not develop disseminated intravascular coagulation

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.

occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism

occurence of major and clinically relevant non-major bleeding

Università degli Studi dell'Insubria

University of Chieti

Ospedale S. Antonio

Poliambulanza Foundation Hospital

Manchester Royal Infirmary

Juntendo University

Marcella Muller

Principal Investigator

Neoplasms

Rare Diseases

Stomach Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

5-fluorouracil

Jian Xiao, MD

A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).

Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC

Infusional Fluorouracil and Weekly Docetaxel as First-line Therapy for Gastric Cancer With Bone Marrow Metastasis and Disseminated Intravascular Coagulation: a Multi-center, Phase II Trail

percentage of participants whose platelet restored to normal range

the interval from treatment to hematological response

the proportion of participants who die within 30 days after the chemotherapy

from the start of chemotherapy to the date of death of any cause or censored at the last date known to be alive

in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0

individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
International Prospective Registry of Disseminated Intravascular Coagulation	NCT03577015	Disseminated In...		18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC	NCT04547153	Gastric Cancer Bone Marrow Met... Disseminated In...	5-fluorouracil Docetaxel	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
International Prospective Registry of Disseminated Intravascular Coagulation	NCT03577015	Disseminated In...		18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for disseminated intravascular coagulation