Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit (CAAT)

Prospective Cohort Study on 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.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter Thrombosis; Intensive Care Unit; Thrombosis, Venous; Central Venous Catheters
• Intervention / Treatment: Diagnostic test: ultrasound

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 Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

• Study Contact: Name: Mauro Panigada, MD; Phone Number: 0039255033258; Email: mauro.panigada@policlinico.mi.it
• Study Contact Backup: Name: chiara Abbruzzese, MD; Phone Number: 0039255033258; Email: chiara.abbruzzese@policlinico.mi.it

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20122
      • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intensive Care Unit (ICU) adult patients requiring Central venous catheter for clinical reasons

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU	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.	Until CVC removal

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Policlinico Hospital

Publications and helpful links

General Publications

• Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.
• Forauer AR, Theoharis CG, Dasika NL. Jugular vein catheter placement: histologic features and development of catheter-related (fibrin) sheaths in a swine model. Radiology. 2006 Aug;240(2):427-34. doi: 10.1148/radiol.2402031129.
• Rooden CJ, Tesselaar ME, Osanto S, Rosendaal FR, Huisman MV. Deep vein thrombosis associated with central venous catheters - a review. J Thromb Haemost. 2005 Nov;3(11):2409-19. doi: 10.1111/j.1538-7836.2005.01398.x. Epub 2005 Jun 24. No abstract available.
• Hrdy O, Strazevska E, Suk P, Vach R, Karlik R, Jarkovsky J, Sas I, Gal R. Central venous catheter-related thrombosis in intensive care patients - incidence and risk factors: A prospective observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Dec;161(4):369-373. doi: 10.5507/bp.2017.034. Epub 2017 Aug 24.
• Nm Bhat M, Venkataraman R, Ramakrishnan N, K Abraham B, Rajagopalan S. Value of Routine Sonographic Screening of Internal Jugular Vein to Detect Catheter Related Thrombosis in Intensive Care Unit. Indian J Crit Care Med. 2019 Jul;23(7):326-328. doi: 10.5005/jp-journals-10071-23207. Erratum In: Indian J Crit Care Med. 2019 Oct;23(10):494.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): October 21, 2022

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Upper Extremity Deep Vein Thrombosis
• Other Study ID Numbers: 172_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No