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Upper Limb Thrombosis Associated With Midline Catheter

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ClinicalTrials.gov Identifier: NCT03036540
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
jiri charvat, University Hospital, Motol

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
Venous Thrombosis Deep (Limbs) 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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots


Intervention Details:
  • 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


Primary Outcome Measures :
  1. The symptomatic and asymptomatic upper limb thrombosis in the patients with midline catheter [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036540


Contacts
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Contact: Jiri Charvat, MD, PhD +420603280598 jiri.charvat@lfmotol.cuni.cz
Contact: Katerina Lisova, Mgr +420224434005 katerina.lisova@fnmotol.cz

Locations
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Czechia
University hospital Recruiting
Praga, Czechia, 15006
Contact: Jiri Charvat, MD,PhD    +420603280598    jiri.charvat@lfmotol.cuni.cz   
Contact: katerina lisova, Mgr    +420224434005    katerina.lisova@fnmotol.cz   
Sponsors and Collaborators
University Hospital, Motol
Investigators
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Study Chair: Jiri Charvat, MD,PhD University Hospital, Motol

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Responsible Party: jiri charvat, prof.MD, PhD, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT03036540     History of Changes
Other Study ID Numbers: UHMotol6022
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The patients with the inseertion of midline catheter during admission in hospital are followed-up for the possible complications including symptoms and signs of symptomatic and asymptomatic upper limb thrombosis using sonography examinations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by jiri charvat, University Hospital, Motol:
upper limb thrombosis, midline catheter

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases