Upper Limb Thrombosis Associated With Midline Catheter

Venous Thrombosis Deep (Limbs) Clinical Trial

Official title:

Symptomatic and Asymptomatic Thrombosis in Midline Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03036540
• Other study ID #: UHMotol6022
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: University Hospital, Motol
• Contact: Jiri Charvat, MD, PhD
• Phone: +420603280598
• Email: jiri.charvat[@]lfmotol.cuni.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The patients admitted in hospital who had midline catheter inserted in upper limb are followed-up for the presence of complications related to catheter introductions. The symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography examination. In the selected group of asymptomatic patients sonography examination is done 8 to 10 days after cathether insertion in order to detect the incidence of the asymptomatic thrombosis

Description:

The patients admitted in hospital who had midline catheter inserted in upper limb are followed-up for the presence of complications related to catheter introductions. The symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography examination. The age, gender, principal diagnosis, the vein were midline catheter is inserted and number of vein punctures for catheter insertion are recorded. Afterward the patients are treated in the ward and the possible complications are recorded. The main concern is about the incidence of upper limb thrombosis. All the complications are recorded as well as date when they has appeared. The statistical analysis is done in order to evaluate the incidence of upper limb symptomatic thrombosis, the duration since insertion to thrombosis manifestation ańad its associations with age, gender, principal diagnosis, selected vein, its size and number of punctures is analysed.

In the selected group of the asymptomatic patients 8 to 10 days after midline insertion upper limb sonography is done in order to detect the presence of the asymptomatic upper limb thrombosis and the same type of analysis as for symptomatic thrombosis is undertaken.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patients admitted to University Hospital suffering from disease when venous access is required for period longer than 5 days or with insufficient peripheral venous access

Exclusion Criteria:

The patients who need another type of venous access, e.g. central venous access

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis
• Venous Thrombosis Deep (Limbs)

Intervention

Device:
• application in midline catheter
The routine insertion of midline catheter for the patients admitted in hospital who needs peripheral venous approach for the period more than 5 days or with the insufficient peripheral veins system

Locations

Country	Name	City	State
Czechia	University hospital	Praga

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The symptomatic and asymptomatic upper limb thrombosis in the patients with midline catheter	The detection of the incidence of upper limb thrombosis and definition of the associated factors	admitted patients in hospital during one year with midline catheter insertion