Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery (THROMBOCAT)

Interest of Doppler Ultrasound for the Assessment of Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery

The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

Study Overview

• Status: Unknown
• Conditions: Critically Ill; Central Venous Catheter Thrombosis; PARENTERAL NUTRITION; POST OPERATIVE
• Intervention / Treatment: Diagnostic test: DOPPLER ULTRASOUND

Detailed Description

The post operative period, wich is a critically ill condition, and history of cancer are related to a high risk of venous thrombosis. Catheter is one of the most common complication of parenteral nutrition and is also related to thrombosis.

The combination of theses conditions increases the risk of venous catheter thrombosis. , Since, there is no data evaluating this risk nowadays, the objective of this study is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les Nancy, France, 54500
    • Recruiting
    • NOVY
    • Contact: Emmanuel NOVY, MD; Phone Number: +33 383157437; Email: e.novy@chru-nancy.fr
    • Contact: Jean Pierre PERTEK, MD; Phone Number: +33 383157398; Email: jp.pertek@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient > 18 years old, admitted in surgical critical care, immediatly after elective carcinologic surgery with a central venous catheter for parenteral nutrition

Description

Inclusion Criteria:

• Hospitalization in surgical intensive care in the immediate post-operative period
• surgery for cancer
• central venous catheter placement for parenteral nutrition
• written consent dated and signed before doppler examination

Exclusion Criteria:

• patient < 18 years old
• pregnancy
• surgery with no indication for parenteral nutrition on central venous access

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
participant	Diagnostic test: DOPPLER ULTRASOUND; MESURE OF THE PRESENCE OR NOT OF A CATHETER RELATED VEIN THROMBOSIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or no of a catheter related thrombosis	Patients will undergo an examination by a specialist in vascular medicine just before removal of the catheter.This specialist also is specialist in vascular doppler ultrasonography. The specialist would search symptoms and signs of deep vein thrombosis : local pain, swelling, redness, warmth. Clinical examinated would be completed by doppler ultrasound : thrombus is detected during a compression test, while cruor is evaluated in B-mode (gray-scale) imaging. This method is very sensitive with regard to detection of the thrombus.	1 day (day of the catheter removal)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical factors associated with the presence of catheter related thrombosis	During the intensive care unit stay, the investigator would prospectively collected data, including : potential risk factors : age, history of venous thrombosis, type of cancer...; details of surgery : type and operating time; details of critically ill period : number and type of organs failures, first mobilisation..; details of the clinical course : occurence of a situation requiring curative anticoagulation..	post operative period, during the intensive care unit stay

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Anticipated): May 31, 2018
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Critical Illness; Thrombosis; Venous Thrombosis; Upper Extremity Deep Vein Thrombosis
• Other Study ID Numbers: 2017-A00043-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No