Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

Completed

• Conditions: Central Venous Catheters; Thrombosis, Venous; Intensive Care Unit; Central Venous Catheter Thrombosis

• Registration Number: NCT04503135
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-07
• Study Start: 2020-09-01
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU	Until CVC removal	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.

Secondary Outcome Measures

Name	Time	Method
the association of thrombosis with alterations of hemocoagulative parameters	Until CVC removal	the association of thrombosis with alterations of hemocoagulative parameters
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	describe the clinical measures that have been taken following the diagnosis of CRT.
Deep venous thrombosis (DVT) proportion and Incidence	Until CVC removal	The proportion of patients developing DVT and the incidence of catheter-related DVT (rate) in patients in ICU carrying CVC.
Proportion of various types of thrombotic apposition	Until CVC removal	The proportion of various types of thrombotic apposition

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, MI, Italy