Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

Prospective Cohort Study on Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

Sponsors

Lead Sponsor: Policlinico Hospital

Source Policlinico Hospital
Brief Summary

This study aims to describe the incidence of catheter-related and non-catheter-related thrombosis in a population of adults in ICU and to assess its correlation with alteration of coagulation parameters.

Detailed Description

Central venous catheter (CVC) is now indispensable in the monitoring and care of patients in intensive care (ICU). Unfortunately, one of the complications of its positioning is catheter-related thrombosis (CRT) and its consequences. Despite the widespread use of CVC and the extensive literature describing its complications, areas of uncertainty regarding the onset, treatment and prevention of CRT persist, especially with regard to asymptomatic thrombosis.

This study aims to describe the incidence of catheter-related and non-catheter-related thrombosis in a population of adults in ICU and to assess its correlation with alteration of coagulation parameters.

The main objective of this study is to assess the proportion of patients developing CRT (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in ICU.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date May 1, 2021
Primary Completion Date April 1, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU Until CVC removal
Secondary Outcome
Measure Time Frame
Proportion of various types of thrombotic apposition Until CVC removal
Deep venous thrombosis (DVT) proportion and Incidence Until CVC removal
the association of thrombosis with alterations of hemocoagulative parameters Until CVC removal
describe the clinical measures that have been taken following the diagnosis of CRT.describe the clinical measures that have been taken following the diagnosis of CRT. Until CVC removal
Enrollment 200
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: ultrasound

Description: ultrasound of the central veins of the neck and chest and a (compression ultra-sound) CUS of the femoral veins will be performed bilaterally

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- patients over the age of 18

- admitted to intensive care who have for clinical reasons need to place a central venous catheter

- signing of informed consent

Exclusion Criteria:

- patients under 18 years of age

- Known cancer status

- Congenital thrombophilia

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
chiara Abbruzzese, MD Principal Investigator Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Overall Contact

Last Name: Mauro Panigada, MD

Phone: 0039255033258

Email: [email protected]

Location
Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Location Countries

Italy

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Policlinico Hospital

Investigator Full Name: Mauro Panigada

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Acronym CAAT
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov