Daily Ultrasound-screening for CVC-related Thrombosis

NCT03327376 | Completed DMC

• 1 other identifier: z2jzk
• Study Type: observational
• Target: 1,262
• Locations: 1 country
• Sites: 1

Brief 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

Central Venous Catheter Thrombosis; Critical Illness; Ultrasonography

Keywords

central venous catheters; venous thrombosis; ultrasound; critical care

Outcome Measures

Primary Outcomes (1)

• the incidence rate of central venous catheters related thrombosis (CRT)

  the percentage of patients who have CRT in all patients included.

  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

  the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.

Study Arms (1)

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

ultrasound-screening DEVICE

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

Characteristic and regularity of CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hanzhou, Zhejiang, 310009, China

Location

Related Publications (5)

• 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.

  PMID: 22883418 BACKGROUND

• 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.

  PMID: 22703114 BACKGROUND

• 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.

  PMID: 27542955 BACKGROUND

• 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: 26398070 RESULT

• 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.

  PMID: 23718723 RESULT

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis; Critical Illness; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mao Zhang, MD

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

  STUDY DIRECTOR

• Weidong Tang, MD

  The First People's Hospital of Fuyang District

  PRINCIPAL INVESTIGATOR

• Zhiping Huang, MD

  Beilun District People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhaohui Ji, MD

  The First People's Hospital of Huzhou

  PRINCIPAL INVESTIGATOR

• Hong Liu, MD

  Lishui Country People's Hospital

  PRINCIPAL INVESTIGATOR

• Lingcong Wang, MD

  The First Affiliated Hospital of Zhejiang University of traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Mingwei Huang, MD

  Jinhua Central Hospital

  PRINCIPAL INVESTIGATOR

• Xingwen Zhang, MD

  Hunan People's Hospital

  PRINCIPAL INVESTIGATOR

• Yunchao Shi, MD

  Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

• Renfei Shan, MD

  Taizhou Hospital

  PRINCIPAL INVESTIGATOR

• Fuzheng Tao, MD

  Taizhou Hospital of integrated traditional Chinese and Western Medicine

  PRINCIPAL INVESTIGATOR

• Yi Wang, MD

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

• Qijiang Chen, MD

  Ninghai First Hospital

  PRINCIPAL INVESTIGATOR

• Ning Zhang, MD

  Lishui Country People's Hospital

  PRINCIPAL INVESTIGATOR

• Jian Hu, MD

  Pinghu first people's Hospital

  PRINCIPAL INVESTIGATOR

• Dengpan Lai, MD

  Affiliated Hospital of Hangzhou Teacher's University

  PRINCIPAL INVESTIGATOR

• Yingru Lu, MD

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Xudong Zheng, MD

  The Third Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Jianbo Gao, MD

  The First People's Hospital of Fuyang District

  PRINCIPAL INVESTIGATOR

• Bei Tang, MD

  Jiande First People's Hospital

  PRINCIPAL INVESTIGATOR

• Wansheng Li, MD

  Taizhou Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoyuan Shen, MD

  Xiaoshan first people's Hospital

  PRINCIPAL INVESTIGATOR

• Yukang Song, MD

  Affiliated Wenling Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Guojuan Ding, MD

  Shaoxing People's Hospital

  PRINCIPAL INVESTIGATOR

• Feng Wu, MD

  Zhejiang Quhua Hospital

  PRINCIPAL INVESTIGATOR

• Xin Tian, MD

  The Central Hospital of Lishui City

  PRINCIPAL INVESTIGATOR

• Shaoyi Xu, MD

  The Second Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

• Weijun Fang, MD

  The Central Hospital of Lishui City

  PRINCIPAL INVESTIGATOR

• LIfeng Wu, MD

  Yuyao People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: October 31, 2017
• Study Start: December 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 24, 2022

Record last verified: 2017-10

Locations

CN (1)