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Clinical Trials/NCT04503135
NCT04503135
Completed
Not Applicable

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

Policlinico Hospital1 site in 1 country203 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Venous Catheters
Sponsor
Policlinico Hospital
Enrollment
203
Locations
1
Primary Endpoint
Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
October 21, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Policlinico Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mauro Panigada

Principal Investigator

Policlinico Hospital

Eligibility 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

Outcomes

Primary Outcomes

Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU

Time Frame: 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 Outcomes

  • 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)
  • Deep venous thrombosis (DVT) proportion and Incidence(Until CVC removal)
  • Proportion of various types of thrombotic apposition(Until CVC removal)

Study Sites (1)

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