Central Venous Catheter ThrombosisDUCTNCT03327376
Daily Ultrasound-screening for CVC-related Thrombosis
An observational study of Central Venous Catheter Thrombosis and Critical Illness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The central venous catheters (CVC) related thrombosis is an issue of importance to ICU clinicians.This study conducts the daily ultrasound-screening for CVC-related thrombosis (DUCT).Its aim is to evaluate the characteristic and regularity of the central venous catheters (CVC) related thrombosis in ICU patients, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Thrombosis, Critical Illness, Ultrasonography
- What is being tested?
- ultrasound-screening
- Type of treatment
- Medical device
- How many people
- 1,262 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 Jan 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: We conduct an observational prospective multicenter study.The patients come from the ICUs of Zhejiang province.
Who may be able to join
- Consecutive patients at least 18 years of age, expected to need a central venous catheterization for at least 48h in ICU.
Who cannot join
- Patients with infection or inflammation or local trauma at the insertion site.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University
Hanzhou, Zhejiang, 310009
About this study
Official title: Daily Ultrasound-screening for CVC-related Thrombosis in Intensive Care Patients
The central venous catheters (CVC) related thrombosis is an issue of importance to ICU clinicians.This study conducts the daily ultrasound-screening for CVC-related thrombosis (DUCT).Its aim is to evaluate the characteristic and regularity of the central venous catheters (CVC) related thrombosis in ICU patients, and optimize the screening program of CVC-related thrombosis.
- Being tested
- ultrasound-screening
- Keywords
- central venous catheters, venous thrombosis, ultrasound, critical care
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis, Critical Illness, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-screeningDevice
Daily ultrasound-screening for CVC-related thrombosis (DUCT) by compression ultrasound and color doppler ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Characteristic and regularity of CRT | The patients who have a central venous catheterization conduct the daily ultrasound-screening for CVC-related Thrombosis (DUCT). Receives: Device: ultrasound-screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of central venous catheters related thrombosis (CRT)
the percentage of patients who have CRT in all patients included.
Measured: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.
Secondary outcomes (1)
the time when the central venous catheters related thrombosis (CRT) occured
which day the CRT is found after central venous catheter.
Measured: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Dec 2017
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheter ThrombosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 1,262 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mao Zhang, MD, Study director, 2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang UniversityWeidong Tang, MD, Principal investigator, The First People's Hospital of Fuyang DistrictZhiping Huang, MD, Principal investigator, Beilun District People's HospitalZhaohui Ji, MD, Principal investigator, The First People's Hospital of HuzhouHong Liu, MD, Principal investigator, Lishui Country People's HospitalLingcong Wang, MD, Principal investigator, The First Affiliated Hospital of Zhejiang University of traditional Chinese MedicineMingwei Huang, MD, Principal investigator, Jinhua Central HospitalXingwen Zhang, MD, Principal investigator, Hunan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327376
- Sponsor's protocol ID
- z2jzk
- Acronym
- DUCT
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2017
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Faustino EV, Spinella PC, Li S, Pinto MG, Stoltz P, Tala J, Card ME, Northrup V, Baker KE, Goodman TR, Chen L, Silva CT. Incidence and acute complications of asymptomatic central venous catheter-related deep venous thrombosis in critically ill children. J Pediatr. 2013 Feb;162(2):387-91. doi: 10.1016/j.jpeds.2012.06.059. Epub 2012 Aug 9.
PubMed 22883418Lee AY, Kamphuisen PW. Epidemiology and prevention of catheter-related thrombosis in patients with cancer. J Thromb Haemost. 2012 Aug;10(8):1491-9. doi: 10.1111/j.1538-7836.2012.04817.x.
PubMed 22703114Refaei M, Fernandes B, Brandwein J, Goodyear MD, Pokhrel A, Wu C. Incidence of catheter-related thrombosis in acute leukemia patients: a comparative, retrospective study of the safety of peripherally inserted vs. centrally inserted central venous catheters. Ann Hematol. 2016 Dec;95(12):2057-2064. doi: 10.1007/s00277-016-2798-4. Epub 2016 Aug 20.
PubMed 27542955Parienti 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 26398070Gentile A, Petit L, Masson F, Cottenceau V, Bertrand-Barat J, Freyburger G, Pinaquy C, Leger A, Cochard JF, Sztark F. Subclavian central venous catheter-related thrombosis in trauma patients: incidence, risk factors and influence of polyurethane type. Crit Care. 2013 May 29;17(3):R103. doi: 10.1186/cc12748.
PubMed 23718723
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Ultrasound-screening for CVC-related Thrombosis in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT03327376
- Acronym / sponsor ID
- DUCT / z2jzk
- Keywords
- central venous catheters, venous thrombosis, ultrasound, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,262 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 31 Oct 2017 (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.
The central venous catheters (CVC) related thrombosis is an issue of importance to ICU clinicians.This study conducts the daily ultrasound-screening for CVC-related thrombosis (DUCT).Its aim is to evaluate the characteristic and regularity of the central venous catheters (CVC) related thrombosis in ICU patients, and optimize the screening program of CVC-related thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Characteristic and regularity of CRT | – | Device: ultrasound-screeningThe patients who have a central venous catheterization conduct the daily ultrasound-screening for CVC-related Thrombosis (DUCT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We conduct an observational prospective multicenter study.The patients come from the ICUs of Zhejiang province.
Key inclusion criteria (1 listed)
- Consecutive patients at least 18 years of age, expected to need a central venous catheterization for at least 48h in ICU.
Key exclusion criteria (1 listed)
- Patients with infection or inflammation or local trauma at the insertion site.
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 |
|---|---|---|
| ultrasound-screeningDaily ultrasound-screening for CVC-related thrombosis (DUCT) by compression ultrasound and color doppler ultrasound. | Device | Characteristic and regularity of CRT |
Primary outcome
the incidence rate of central venous catheters related thrombosis (CRT)
Time frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.
the percentage of patients who have CRT in all patients included.
1 secondary outcome
the time when the central venous catheters related thrombosis (CRT) occured
Time frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.
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 24 Oct 2022.
- Background: PubMed 22883418Faustino EV, Spinella PC, Li S, Pinto MG, Stoltz P, Tala J, Card ME, Northrup V, Baker KE, Goodman TR, Chen L, Silva CT. Incidence and acute complications of asymptomatic central venous catheter-related deep venous thrombosis in critically ill children. J Pediatr. 2013 Feb;162(2):387-91. doi: 10.1016/j.jpeds.2012.06.059. Epub 2012 Aug 9.
- Background: PubMed 22703114Lee AY, Kamphuisen PW. Epidemiology and prevention of catheter-related thrombosis in patients with cancer. J Thromb Haemost. 2012 Aug;10(8):1491-9. doi: 10.1111/j.1538-7836.2012.04817.x.
- Background: PubMed 27542955Refaei M, Fernandes B, Brandwein J, Goodyear MD, Pokhrel A, Wu C. Incidence of catheter-related thrombosis in acute leukemia patients: a comparative, retrospective study of the safety of peripherally inserted vs. centrally inserted central venous catheters. Ann Hematol. 2016 Dec;95(12):2057-2064. doi: 10.1007/s00277-016-2798-4. Epub 2016 Aug 20.
- Results publication: 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.
- Results publication: PubMed 23718723Gentile A, Petit L, Masson F, Cottenceau V, Bertrand-Barat J, Freyburger G, Pinaquy C, Leger A, Cochard JF, Sztark F. Subclavian central venous catheter-related thrombosis in trauma patients: incidence, risk factors and influence of polyurethane type. Crit Care. 2013 May 29;17(3):R103. doi: 10.1186/cc12748.
- Individual participant dataSharing planned: Undecided
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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.
Mao Zhang, MD study director
2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University
Weidong Tang, MD principal investigator
The First People's Hospital of Fuyang District
Zhiping Huang, MD principal investigator
Beilun District People's Hospital
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 and Critical Illness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 1 inclusion and 1 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 24 Oct 2022. 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 China. 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?
the incidence rate of central venous catheters related thrombosis (CRT) (time frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.). 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 NCT03327376, which also lists 5 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 24 Oct 2022.