Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

Intensive Care Unit Clinical Trial

— CAAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503135
• Other study ID #: 172_2020
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: October 21, 2022

Study information

• Verified date: April 2023
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheter Thrombosis
• Central Venous Catheters
• Intensive Care Unit
• Thrombosis
• Thrombosis, Venous
• Upper Extremity Deep Vein Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of various types of thrombotic apposition	The proportion of various types of thrombotic apposition	Until CVC removal
Secondary	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
Secondary	the association of thrombosis with alterations of hemocoagulative parameters	the association of thrombosis with alterations of hemocoagulative parameters	Until CVC removal
Secondary	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