Upper Limb Thrombosis Associated With Midline Catheter

Sponsor
University Hospital, Motol (Other)
Overall Status
Unknown status
CT.gov ID
NCT03036540
Collaborator
(none)
400
1
24
16.7

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: application in midline catheter

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Symptomatic and Asymptomatic Thrombosis in Midline Catheter
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Outcome Measures

Primary Outcome Measures

  1. The symptomatic and asymptomatic upper limb thrombosis in the patients with midline catheter [admitted patients in hospital during one year with midline catheter insertion]

    The detection of the incidence of upper limb thrombosis and definition of the associated factors

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital Praga Czechia 15006

Sponsors and Collaborators

  • University Hospital, Motol

Investigators

  • Study Chair: Jiri Charvat, MD,PhD, University Hospital, Motol

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
jiri charvat, prof.MD, PhD, University Hospital, Motol
ClinicalTrials.gov Identifier:
NCT03036540
Other Study ID Numbers:
  • UHMotol6022
First Posted:
Jan 30, 2017
Last Update Posted:
Oct 11, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by jiri charvat, prof.MD, PhD, University Hospital, Motol
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2018