Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03577015
Other study ID # 184/2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date June 1, 2021

Study information

Verified date August 2018
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Alessandro Squizzato, MD PhD
Email alessandro.squizzato@uninsurbia.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms

  • Disseminated Intravascular Coagulation

Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam

Sponsors (7)

Lead Sponsor Collaborator
Marcella Muller Juntendo University, Manchester Royal Infirmary, Ospedale S. Antonio, Poliambulanza Foundation Hospital, Università degli Studi dell'Insubria, University of Chieti

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 mortality mortality rates in patient who develop or do not develop disseminated intravascular coagulation 28 days
Secondary 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. 28 days
Secondary Arterial thromboembolic events occurence of arterial thromboembolic events including myocardial infarction, stroke, peripheral embolism 28 days
Secondary Major and clinically-relevant non-major bleeding occurence of major and clinically relevant non-major bleeding 28 days
See also
  Status Clinical Trial Phase
Completed NCT04580563 - Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study N/A
Completed NCT01704001 - Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment Phase 4
Terminated NCT00299949 - Thrombin Generation and Thromboelastography in Non-overt DIC N/A
Withdrawn NCT04363840 - The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations Phase 2
Completed NCT04873349 - Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of COVID-19 Patients N/A
Withdrawn NCT01090115 - Study to Look at the Effects of ART-123 on Patients With Sepsis and Disseminated Intravascular Coagulation (DIC) Phase 2
Active, not recruiting NCT04107402 - PLatelets Acetyl-CoA Carboxylase Phosphorylation State in SEPtic Shock N/A
Terminated NCT00506519 - Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis Phase 2
Completed NCT00487656 - Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation Phase 2
Completed NCT03714048 - Blood Management During ECMO for Cardiac Support
Completed NCT04547153 - Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC Phase 2
Recruiting NCT05995093 - The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
Completed NCT04460664 - Coagulation Changes Associated With COVID-19 Infection
Completed NCT04356950 - Analysis of the Coagulopathy Developed by COVID-19 Infected Patients
Completed NCT04356144 - Thrombomodulin-modified Thrombin Generation Assay (TGA-TM) in Patients With Critical Infections
Recruiting NCT06363149 - Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients
Recruiting NCT02654561 - Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation Phase 3
Active, not recruiting NCT06373159 - An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
Completed NCT03716310 - Platelet Reactivity in Septic Shock