NCT04302376|Completed
Thrombotic Complications After Central Venous Catheterization
TARZAN
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TARZAN
Sponsor study identifier
observational
173
1 country
1
Study Start
December 1, 2019
Actual (reported)Primary Completion
February 1, 2022
Actual (reported)Study Completion
February 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2019
Actual (reported)December 1, 2019
Actual (reported)March 10, 2020
Actual (reported)February 1, 2022
Actual (reported)February 1, 2022
Actual (reported)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
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
The presence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound.
The absence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound.
Doppler and compression ultrasound to detect catheter-related thrombosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
VU University Medical Center
Amsterdam, North Holland, 1081 HZ, Netherlands
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.
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.
173 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2019
First Posted
March 10, 2020
Study Start
December 1, 2019
Actual (reported)Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters
Continuous Heparin Infusion to Prevent Catheter-related Thrombosis
Contact the study team to confirm eligibility.
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.
Primary Completion
February 1, 2022
Actual (reported)Study Completion
February 1, 2022
Actual (reported)Last Updated
February 13, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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