Central Venous Catheter ThrombosisTARZANNCT04302376
Thrombotic Complications After Central Venous Catheterization
An observational study of Central Venous Catheter Thrombosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Thrombosis
- What is being tested?
- Cather-related thrombosis ultrasonography
- How many people
- 173 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2019to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Central venous cannulation of the internal jugular vein, subclavian vein, or femoral vein
- ≥ 48 hours catheter indwelling time
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081 HZ
About this study
Official title: Thrombotic Complications After Central Venous Catheterization: a Prospective Observational Study
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.
Read the detailed description
INTRODUCTION AND RATIONALE
Since its introduction, central venous catheter (CVC) use has been increasing and is now indispensable in modern-day medical practice. Besides its imperative use in critically ill patients, there are multiple complications associated with central venous catheterization. Complications are mechanical, infectious or thrombotic in origin. There is a growing body of literature that recognises the potential deleterious consequences of catheter-related bloodstream infections and this complication has been the main focus of research. In contrast, despite catheter-related thrombosis being a well-known complication and accounting for approximately 15 percent of all venous thromboses in ICU patients, its exact incidence and potential consequences in ICU patients remain unclear.
Histologically, due to intravascular movement of the CVC focal areas of endothelial injury in the vein wall adjacent to the catheter occur. Simultaneously, a fibrin sheath grows along the catheter surface from the venotomy site. The fibrin sheath, in combination with endothelial injury and a decreased blood flow around the catheter triggers the development of catheter-related thrombosis. The formed thrombus can gradually increase in size until there is occlusion of the vein and, subsequently, symptoms of localized swelling, pain, tenderness and erythema along the course of the vein may occur.
Up to now CVCs are removed without routinely investigating the presence of catheter-related thrombosis. Therefore, its exact incidence is ambiguous and among asymptomatic patients the natural course of catheter-related thrombosis remains uncertain. Potential consequences of catheter-related thrombosis are not insubstantial; they include pulmonary embolism, post-thrombotic syndrome, thrombophlebitis, treatment delay, and loss of venous access. However, a study by Jones et al., conducted in children who received a CVC in the internal jugular or femoral vein, showed low risk for developing short and long-term sequalae after catheter-related thrombosis. Moreover, another study by White et al. showed no increased risk of developing pulmonary embolism after central venous catheter placement.
To date, there is no consensus regarding treatment of catheter-related thrombosis in ICU patients. In case it becomes symptomatic, guidelines for lower extremity deep vein thrombosis are followed and patients are treated accordingly. However, in case catheter-related thrombosis is an accidental find and remains asymptomatic, treatment is more controversial. Some physicians decide to treat it with anticoagulants, whereas others do not treat it at all.
If we take into account that the natural history of catheter-related thrombosis remains unclear in adult ICU patients and its treatment is even more controversial, a study is warranted that investigates the incidence and potential sequelae of catheter-related thrombosis. The primary aim of this study is to evaluate the incidence of catheter-related thrombosis in adult ICU patients and to investigate its relationship with potentially hazardous sequelae.
OBJECTIVES
Primary Objective:
- To evaluate the prevalence and incidence of catheter-related thrombosis in adult ICU patients
Secondary Objectives:
- To investigate the correlation between catheter-related thrombosis and catheter-related infections
- To identify potential risk factors associated with catheter-related thrombosis
- To investigate the association of catheter-related thrombosis with potential sequalae
- Conditions
- Central Venous Catheter Thrombosis
- Being tested
- Cather-related thrombosis ultrasonography
- Keywords
- central venous catheter, catheter-related thrombosis, CVC, ultrasound
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cather-related thrombosis ultrasonographyDiagnostic test
Doppler and compression ultrasound to detect catheter-related thrombosis
| Study group | Role | What they receive |
|---|---|---|
| Catheter-related thrombosis | The presence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound. Receives: 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. Receives: Diagnostic Test: Cather-related thrombosis ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Catheter-related infections will be divided into three subgroups:
Local catheter infection: clinical signs of infection at CVC insertion site (redness, pus) in combination with a positive culture from the skin and/or pus at the insertion site Clinical suspicion of catheter infection: one or more of the following: local infection; fever of unknown origin, with CVC present for ≥ 3 days; positive blood cultures without clear focus of infection at other site; normalization of temperature after CVC removal Catheter-related bloodstream infection (CRBSI): Clinical suspicion of infection (fever, chills, unexplained leukocytosis, hypotension, tachycardia etc.) with no clear focus apart from the central line, or signs of local infection around the insertion site, in combination with a positive culture from a catheter segment and at least one positive blood culture of the same pathogen. The blood sample must be drawn from a different location than from the potentially infected central line.
Measured: 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.
Potential risk factors are identified using previously published literature or are theoretically based on Virchow's triad: patient characteristics, CVC-tip location, lumen diameter, number of lumens, insertion site, duration of insertion procedure, arterial puncture, vein diameter, (lumen diameter/vein diameter) indwelling time, number of cannulation attempts, elective or emergency insertion and experience of investigator inserting the CVC.
Measured: 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
Pulmonary embolism as seen on CT
Measured: 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
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.
Measured: 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.
Suppurative thrombophlebitis: persistent bacteraemia for 72 hours after catheter removal despite appropriate antimicrobial therapy in combination with symptomatic or asymptomatic thrombosis
Measured: Date of central venous catheter removal up to 1 month of follow up, hospital discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Dec 2019
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheter ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper M Smit, MD, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302376
- Sponsor's protocol ID
- 2019.575
- Acronym
- TARZAN
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2019
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Coded data can be shared with other researchers after publication of study
Publications
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.
PubMed 26398070Jones 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.
PubMed 30377196Wall 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.
PubMed 28979481
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombotic Complications After Central Venous Catheterization: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04302376
- Acronym / sponsor ID
- TARZAN / 2019.575
- Conditions
- Central Venous Catheter Thrombosis
- Keywords
- central venous catheter, catheter-related thrombosis, CVC, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION AND RATIONALE
Since its introduction, central venous catheter (CVC) use has been increasing and is now indispensable in modern-day medical practice. Besides its imperative use in critically ill patients, there are multiple complications associated with central venous catheterization. Complications are mechanical, infectious or thrombotic in origin. There is a growing body of literature that recognises the potential deleterious consequences of catheter-related bloodstream infections and this complication has been the main focus of research. In contrast, despite catheter-related thrombosis being a well-known complication and accounting for approximately 15 percent of all venous thromboses in ICU patients, its exact incidence and potential consequences in ICU patients remain unclear.
Histologically, due to intravascular movement of the CVC focal areas of endothelial injury in the vein wall adjacent to the catheter occur. Simultaneously, a fibrin sheath grows along the catheter surface from the venotomy site. The fibrin sheath, in combination with endothelial injury and a decreased blood flow around the catheter triggers the development of catheter-related thrombosis. The formed thrombus can gradually increase in size until there is occlusion of the vein and, subsequently, symptoms of localized swelling, pain, tenderness and erythema along the course of the vein may occur.
Up to now CVCs are removed without routinely investigating the presence of catheter-related thrombosis. Therefore, its exact incidence is ambiguous and among asymptomatic patients the natural course of catheter-related thrombosis remains uncertain. Potential consequences of catheter-related thrombosis are not insubstantial; they include pulmonary embolism, post-thrombotic syndrome, thrombophlebitis, treatment delay, and loss of venous access. However, a study by Jones et al., conducted in children who received a CVC in the internal jugular or femoral vein, showed low risk for developing short and long-term sequalae after catheter-related thrombosis. Moreover, another study by White et al. showed no increased risk of developing pulmonary embolism after central venous catheter placement.
To date, there is no consensus regarding treatment of catheter-related thrombosis in ICU patients. In case it becomes symptomatic, guidelines for lower extremity deep vein thrombosis are followed and patients are treated accordingly. However, in case catheter-related thrombosis is an accidental find and remains asymptomatic, treatment is more controversial. Some physicians decide to treat it with anticoagulants, whereas others do not treat it at all.
If we take into account that the natural history of catheter-related thrombosis remains unclear in adult ICU patients and its treatment is even more controversial, a study is warranted that investigates the incidence and potential sequelae of catheter-related thrombosis. The primary aim of this study is to evaluate the incidence of catheter-related thrombosis in adult ICU patients and to investigate its relationship with potentially hazardous sequelae.
OBJECTIVES
Primary Objective:
- To evaluate the prevalence and incidence of catheter-related thrombosis in adult ICU patients
Secondary Objectives:
- To investigate the correlation between catheter-related thrombosis and catheter-related infections
- To identify potential risk factors associated with catheter-related thrombosis
- To investigate the association of catheter-related thrombosis with potential sequalae
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-related thrombosis | – | Diagnostic Test: Cather-related thrombosis ultrasonographyThe presence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound. |
| No catheter-related thrombosis | – | Diagnostic Test: Cather-related thrombosis ultrasonographyThe absence of occlusive or nonocclusive thrombus in the insertion vein ad identified on Doppler and compression ultrasonography and compression ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Central venous cannulation of the internal jugular vein, subclavian vein, or femoral vein
- ≥ 48 hours catheter indwelling time
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cather-related thrombosis ultrasonographyDoppler and compression ultrasound to detect catheter-related thrombosis | Diagnostic test | Catheter-related thrombosis, No catheter-related thrombosis |
Primary outcome
Incidence and prevalence of catheter-related thrombosis
Time frame: Date of central venous catheter insertion until date of catheter removal, assessed up to 28 days after CVC insertion
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.
5 secondary outcomes
Correlation of catheter-related thrombosis with catheter-related infections
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Date of central venous catheter removal up to 1 month of follow up, hospital discharge or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 26398070Parienti 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.
- Background: PubMed 30377196Jones 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.
- Background: PubMed 28979481Wall 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.
- Individual participant dataSharing planned: Undecided. Coded data can be shared with other researchers after publication of study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter Thrombosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and prevalence of catheter-related thrombosis (time frame: Date of central venous catheter insertion until date of catheter removal, assessed up to 28 days after CVC insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302376, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.