Clinical trial NCT04503135: Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit
Official title: Prospective Cohort Study on Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Catheters
Central Venous Catheter Thrombosis
Thrombosis, Venous
Intensive Care Unit
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care Unit (ICU) adult patients requiring Central venous catheter for clinical reasons

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.

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

Primary outcomes:
measure: Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU
timeFrame: Until CVC removal
Secondary outcomes:
measure: Proportion of various types of thrombotic apposition
timeFrame: Until CVC removal
measure: Deep venous thrombosis (DVT) proportion and Incidence
timeFrame: Until CVC removal
measure: the association of thrombosis with alterations of hemocoagulative parameters
timeFrame: Until CVC removal
measure: 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.
timeFrame: Until CVC removal
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: MI
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: chiara Abbruzzese, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.