Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

NCT ID: NCT04503135

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-10-21

Brief Summary

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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

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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.

Conditions

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Central Venous Catheters Central Venous Catheter Thrombosis Thrombosis, Venous Intensive Care Unit

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mauro Panigada

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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chiara Abbruzzese, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 16864670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15975139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22315267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28839334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31406439 (View on PubMed)

Other Identifiers

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172_2020

Identifier Type: -

Identifier Source: org_study_id

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