Venous Thrombosis Deep (Limbs)NCT03036540
Upper Limb Thrombosis Associated With Midline Catheter
An observational study of Venous Thrombosis Deep (Limbs), run by University Hospital, Motol at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis Deep (Limbs)
- What is being tested?
- application in midline catheter
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- The patients who need another type of venous access, e.g. central venous access
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University hospital
Prague, 15006
Jiri Charvat, MD,PhD, +420603280598, jiri.charvat@lfmotol.cuni.cz
katerina lisova, Mgr, +420224434005, katerina.lisova@fnmotol.cz
About this study
Official title: Symptomatic and Asymptomatic Thrombosis in Midline Catheter
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
Read the 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.
- Conditions
- Venous Thrombosis Deep (Limbs)
- Being tested
- application in midline catheter
- Keywords
- upper limb thrombosis, midline catheter
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application in midline catheterDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: admitted patients in hospital during one year with midline catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thrombosis Deep (Limbs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jiri charvat, University Hospital, Motol
- Investigators
- Jiri Charvat, MD,PhD, Study chair, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036540
- Sponsor's protocol ID
- UHMotol6022
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic and Asymptomatic Thrombosis in Midline Catheter
- ClinicalTrials.gov ID
- NCT03036540
- Acronym / sponsor ID
- UHMotol6022
- Conditions
- Venous Thrombosis Deep (Limbs)
- Keywords
- upper limb thrombosis, midline catheter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- The patients who need another type of venous access, e.g. central venous access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application in midline catheterThe 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 | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Charvat, MD,PhD study chair
University Hospital, Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis Deep (Limbs), run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiri Charvat, MD, PhD (+420603280598, jiri.charvat@lfmotol.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.