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CompletedNCT04503135CAATUpdated May 1, 2023

Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

An observational study in Central Venous Catheters, Central Venous Catheter Thrombosis and Thrombosis, Venous, sponsored by Policlinico Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by Policlinico Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
203
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Central Venous Catheters
  • Central Venous Catheter Thrombosis
  • Thrombosis, Venous
  • Intensive Care Unit
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In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 203 is close to the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • patients under 18 years of age
  • Known cancer status
  • Congenital thrombophilia
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
203 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testultrasound

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Until CVC removal

Secondary outcomes

  1. Proportion of various types of thrombotic apposition

    The proportion of various types of thrombotic apposition

    Time frame: Until CVC removal

  2. 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.

    Time frame: Until CVC removal

  3. the association of thrombosis with alterations of hemocoagulative parameters

    the association of thrombosis with alterations of hemocoagulative parameters

    Time frame: Until CVC removal

  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.

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

    Time frame: Until CVC removal

07

Study locations

1 site
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milano, MI 20122, Italy
08

References and documents

Publications

  • 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. PubMed 16864670 ↗
  • 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. PubMed 15975139 ↗
  • 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. PubMed 22315267 ↗
  • 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. PubMed 28839334 ↗
  • 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. doi: 10.5005/jp-journals-10071-23207c. PubMed 31406439 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04503135
Lead sponsor
Policlinico Hospital
Responsible party
Mauro Panigada (Principal Investigator, Policlinico Hospital) — Principal investigator
First posted
Aug 7, 2020
Start date
Sep 1, 2020
Primary completion
Oct 21, 2022
Completion
Oct 21, 2022
Last update
May 1, 2023

Study contacts

chiara Abbruzzese, MD
principal investigator · Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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