NCT04302376

Brief Summary

Rationale: Complications related to central venous catheterization are mechanical, infectious or thrombotic in origin. Potential complications of catheter-related thrombosis are not insubstantial and include pulmonary embolism, post-thrombotic syndrome or thrombophlebitis. Prevalence and incidence of catheter-related thrombosis at the intensive care unit is unclear and treatment, especially of asymptomatic thrombosis, remains ambiguous. Therefore a study is warranted that evaluates the prevalence and incidence of catheter-related thrombosis and investigates its potential consequences. We hypothesize that the incidence of catheter-related thrombosis is 5-15%. Objective: To assess the prevalence and incidence of symptomatic and asymptomatic catheter-related thrombosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

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

November 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

November 25, 2019

Last Update Submit

February 8, 2023

Conditions

Central Venous Catheter Thrombosis

Keywords

central venous cathetercatheter-related thrombosisCVCultrasound

Outcome Measures

Primary Outcomes (1)

  • Incidence and prevalence of catheter-related thrombosis

    Prevalence and incidence of catheter-related thrombosis per 1000 catheter days. Catheter-related thrombosis will be divided into asymptomatic and symptomatic catheter-related thrombosis: Asymptomatic thrombosis: the presence of occlusive or nonocclusive thrombus in insertion vein as identified on Doppler and compression ultrasonography and the absence of any clinical signs or symptoms of thrombosis of the area Symptomatic thrombosis: The presence of occlusive or nonocclusive thrombus in the insertion vein as identified on Doppler and compression ultrasonography and the presence of at least 1 of the following signs or symptoms: swelling, pain, redness, or discoloration of the area; dysfunction of the CVC.

    Date of central venous catheter insertion until date of catheter removal, assessed up to 28 days after CVC insertion

Secondary Outcomes (5)

  • Correlation of catheter-related thrombosis with catheter-related infections

    Date of central venous catheter insertion until date of catheter removal, assessed up to 28 days after CVC insertion

  • Risk factors associated with catheter-related thrombosis.

    Date of central venous catheter insertion until date of catheter removal, assessed up to 28 days after CVC insertion

  • Association of catheter-related thrombosis with development of pulmonary embolism

    Date of central venous catheter removal up to 1 month of follow up, hospital discharge or death

  • Association of catheter-related thrombosis with development of symptomatic thrombosis

    Date of central venous catheter removal up to 1 month of follow up, hospital discharge or death

  • Association of catheter-related thrombosis with development of suppurative (septic) thrombophlebitis.

    Date of central venous catheter removal up to 1 month of follow up, hospital discharge or death

Study Arms (2)

Catheter-related thrombosis

The presence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound.

Diagnostic Test: Cather-related thrombosis ultrasonography

No catheter-related thrombosis

The absence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound.

Diagnostic Test: Cather-related thrombosis ultrasonography

Interventions

Cather-related thrombosis ultrasonographyDIAGNOSTIC_TEST

Doppler and compression ultrasound to detect catheter-related thrombosis

Catheter-related thrombosisNo catheter-related thrombosis

Eligibility Criteria

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

All adult (≥18 years) patients admitted to the ICU receiving a CVC at the ICU, are admitted to the ICU after surgery and received a CVC in advance, or are admitted from the emergency department and have a CVC placed just before ICU admission.

You may qualify if:

  • Central venous cannulation of the internal jugular vein, subclavian vein, or femoral vein
  • ≥ 48 hours catheter indwelling time

You may not qualify if:

  • Removal of the CVC within 48 hours after placement
  • Pre-existent thrombosis at vein of insertion site
  • Discharge of patients from ICU with CVC in situ
  • Inability to perform compression and colour Doppler ultrasound evaluation of cannulated vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HZ, Netherlands

Location

Related Publications (3)

  • Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

    PMID: 26398070BACKGROUND

  • Jones S, Butt W, Monagle P, Cain T, Newall F. The natural history of asymptomatic central venous catheter-related thrombosis in critically ill children. Blood. 2019 Feb 21;133(8):857-866. doi: 10.1182/blood-2018-05-849737. Epub 2018 Oct 30.

    PMID: 30377196BACKGROUND

  • Wall C, Moore J, Thachil J. Catheter-related thrombosis: A practical approach. J Intensive Care Soc. 2016 May;17(2):160-167. doi: 10.1177/1751143715618683. Epub 2015 Dec 3.

    PMID: 28979481BACKGROUND

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

November 25, 2019

First Posted

March 10, 2020

Study Start

December 1, 2019

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

NL(1)