CompletedNCT03327376DUCTUpdated Oct 24, 2022

Daily Ultrasound-screening for CVC-related Thrombosis

An observational study in Central Venous Catheter Thrombosis, Critical Illness and Ultrasonography, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-24.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,262
Ages: 18 Years and older
Sex: All

Study 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 optimize the screening program of CVC-related thrombosis.

Conditions studied

Central Venous Catheter Thrombosis
Critical Illness
Ultrasonography

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Keywords

central venous catheters
venous thrombosis
ultrasound
critical care

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

We conduct an observational prospective multicenter study.The patients come from the ICUs of Zhejiang province.

Inclusion criteria

Consecutive patients at least 18 years of age, expected to need a central venous catheterization for at least 48h in ICU.

Exclusion criteria

Exclusion Criteria:

Patients with infection or inflammation or local trauma at the insertion site.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,262 participants (actual)
Patient registry: No

Groups and cohorts

Characteristic and regularity of CRT
The patients who have a central venous catheterization conduct the daily ultrasound-screening for CVC-related Thrombosis (DUCT).
Device: ultrasound-screening

Interventions

Deviceultrasound-screening
Daily ultrasound-screening for CVC-related thrombosis (DUCT) by compression ultrasound and color doppler ultrasound.

What researchers measure

Primary outcomes

the incidence rate of central venous catheters related thrombosis (CRT)
the percentage of patients who have CRT in all patients included.
Time frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.

Secondary outcomes

the time when the central venous catheters related thrombosis (CRT) occured
which day the CRT is found after central venous catheter.
Time frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.

Study locations

1 site

2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University
Hanzhou, Zhejiang 310009, China

References and documents

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 22883418 ↗
Lee 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 22703114 ↗
Refaei 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 27542955 ↗
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 26398070 ↗
Gentile 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 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03327376
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party: Sponsor
First posted: Oct 31, 2017
Start date: Dec 1, 2017
Primary completion: Jan 1, 2022
Completion: Jan 1, 2022
Last update: Oct 24, 2022

Study contacts

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

Zhaohui Ji, MD

principal investigator · The First People's Hospital of Huzhou

Hong Liu, MD

principal investigator · Lishui Country People's Hospital

Lingcong Wang, MD

principal investigator · The First Affiliated Hospital of Zhejiang University of traditional Chinese Medicine

Mingwei Huang, MD

principal investigator · Jinhua Central Hospital

Xingwen Zhang, MD

principal investigator · Hunan People's Hospital

Yunchao Shi, MD

principal investigator · Affiliated Hospital of Jiaxing University

Renfei Shan, MD

principal investigator · Taizhou Hospital

Fuzheng Tao, MD

principal investigator · Taizhou Hospital of integrated traditional Chinese and Western Medicine

Yi Wang, MD

principal investigator · First People's Hospital of Hangzhou

Qijiang Chen, MD

principal investigator · Ninghai First Hospital

Ning Zhang, MD

principal investigator · Lishui Country People's Hospital

Jian Hu, MD

principal investigator · Pinghu first people's Hospital

Dengpan Lai, MD

principal investigator · Affiliated Hospital of Hangzhou Teacher's University

Yingru Lu, MD

principal investigator · First Affiliated Hospital of Wenzhou Medical University

Xudong Zheng, MD

principal investigator · Ruian People's Hospital

Jianbo Gao, MD

principal investigator · The First People's Hospital of Fuyang District

Bei Tang, MD

principal investigator · Jiande First People's Hospital

Wansheng Li, MD

principal investigator · Taizhou Hospital

Xiaoyuan Shen, MD

principal investigator · Xiaoshan first people's Hospital

Yukang Song, MD

principal investigator · Affiliated Wenling Hospital of Wenzhou Medical University

Guojuan Ding, MD

principal investigator · Shaoxing People's Hospital

Feng Wu, MD

principal investigator · Zhejiang Quhua Hospital

Xin Tian, MD

principal investigator · The Central Hospital of Lishui City

Shaoyi Xu, MD

principal investigator · The Second Affiliated Hospital of Jiaxing University

Weijun Fang, MD

principal investigator · The Central Hospital of Lishui City

LIfeng Wu, MD

principal investigator · Yuyao People's Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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