NCT04503135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2022

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

August 3, 2020

Last Update Submit

April 28, 2023

Conditions

Central Venous CathetersCentral Venous Catheter ThrombosisThrombosis, VenousIntensive Care Unit

Outcome Measures

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.

    Until CVC removal

Secondary Outcomes (4)

  • Proportion of various types of thrombotic apposition

    Until CVC removal

  • Deep venous thrombosis (DVT) proportion and Incidence

    Until CVC removal

  • 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.

    Until CVC removal

Interventions

ultrasoundDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Related Publications (5)

  • 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.

    PMID: 16864670BACKGROUND

  • 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.

    PMID: 15975139BACKGROUND

  • 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.

    PMID: 22315267BACKGROUND

  • 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.

    PMID: 28839334BACKGROUND

  • 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.

    PMID: 31406439BACKGROUND

MeSH Terms

Conditions

Upper Extremity Deep Vein ThrombosisVenous Thrombosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • chiara Abbruzzese, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 7, 2020

Study Start

September 1, 2020

Primary Completion

October 21, 2022

Study Completion

October 21, 2022

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations

IT(1)