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

Critically Ill Clinical Trial

— THROMBOCAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03157245
• Other study ID #: 2017-A00043-50
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: June 7, 2017
• Start date: June 2, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheter Thrombosis
• Critical Illness
• Critically Ill
• PARENTERAL NUTRITION
• POST OPERATIVE
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• DOPPLER ULTRASOUND
MESURE OF THE PRESENCE OR NOT OF A CATHETER RELATED VEIN THROMBOSIS

Locations

Country	Name	City	State
France	NOVY	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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