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Completed

NCT Number: NCT04503135

Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

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.

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Key information

Conditions

Central Venous Catheters Cardiovascular Diseases Central Venous Catheter Thrombosis Embolism and Thrombosis Intensive Care Unit Thrombosis Thrombosis, Venous Upper Extremity Deep Vein Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Proportion of various types of thrombotic apposition

    Time frame: Until CVC removal

    The proportion of various types of thrombotic apposition

  2. Deep venous thrombosis (DVT) proportion and Incidence

    Time frame: Until CVC removal

    The proportion of patients developing DVT and the incidence of catheter-related DVT (rate) in patients in ICU carrying CVC.

  3. the association of thrombosis with alterations of hemocoagulative parameters

    Time frame: Until CVC removal

    the association of thrombosis with alterations of hemocoagulative parameters

  4. 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.

    Time frame: Until CVC removal

    describe the clinical measures that have been taken following the diagnosis of CRT.

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

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

Acronym: CAAT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2020
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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