ThrombosisMidDATANCT04131088
"Follow-up of Midlines Placed Outside the Intensive Care Unit: What Side Effects? An Observational Study"
An observational study of Thrombosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Follow up of midlines
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2019to 15 Dec 2022
- 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: All patients concerned with this study requiring a midline for any indication and hospitalized in a department other than intensive care or intensive care.
Who may be able to join
- Adult patient
- No opposition to the study
- Patient requiring a midline
Who cannot join
- Patient in Intensive Care Unit or acute care unit.
- Patient with a contra indication to midline insertion: arterio-venous fistula, history of axillary lymph node clearance or radiotherapy in the infusion arm, presence of infectious skin lesions near the infusion area, presence of a prosthesis on the infusion arm or hemiplegic arm.
- Patient under legal protection measure
- Patient already enrolled
- Minor patient;
- Pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study"
Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.
Read the detailed description
The midline is a deep peripheral venous catheter whose insertion is between the lower and upper third of the arm and whose distal end does not extend beyond the axillary vein. It requires the identification of the vein by ultrasound which reserves its installation for professionals trained and authorized to use the ultrasound scanner.
Midline is currently indicated for intravenous treatments > 7 days and in patients with precarious venous capital. According to the manufacturer's instructions, it can be kept in place for up to 30 days, while the recommendations of the Centers disease of control specify that this period could be extended to 49 days.
Its use is expanding rapidly in France, thus meeting the needs of patients who do not require a central line and whose use of a standard peripheral venous catheter is not possible (low venous capital or treatment duration > 7 days). Its installation, essentially carried out by qualified anaesthetists, does not increase medical planning and is therefore an attractive alternative to the installation of a central catheter whose complications (thrombosis and infections) are known.
The only data on the complication rate, estimated at 1-2%, are from low-potency observational studies. In the absence of high-level evidence, most of the good practice recommendations published in 2019 are based on expert consensus.
This leads us to conduct a large-scale observational study to assess the complication rate and identify the associated factors. This study will provide professionals with reliable scientific data for the next review of good practice recommendations.
- Conditions
- Thrombosis
- Being tested
- Follow up of midlines
- Keywords
- Midline catheter, adverse event, catheter-related bloodstream infections, thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up of midlinesOther
The follow-up data to be collected will be recorded on a monitoring logbook that will follow the patient (Appendix 4). The latter will be involved in the follow-up of his data insofar as he will be able to solicit the various professionals performing care on his midline in order to aim at the exhaustiveness of the filling of the book.
What is being measured
The primary outcome is the main question the study is designed to answer.
assess numbers of adverse events
catheter related infection yes/no vein thrombosis yes/no occlusion yes/no exposition time to a midline catheter
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start23 Dec 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131088
- Sponsor's protocol ID
- RC19_0073
- Acronym
- MidDATA
- Status last verified
- Sep 2021
- First submitted
- 16 Oct 2019
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Derouin Y, Le Thuaut A, Dauvergne J, Cinotti R, Cartron E. Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study). BMJ Open. 2023 Jul 18;13(7):e067796. doi: 10.1136/bmjopen-2022-067796.
PubMed 37463802
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study"
- ClinicalTrials.gov ID
- NCT04131088
- Acronym / sponsor ID
- MidDATA / RC19_0073
- Conditions
- Thrombosis
- Keywords
- Midline catheter, adverse event, catheter-related bloodstream infections, thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- 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.
Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.
Detailed description
The midline is a deep peripheral venous catheter whose insertion is between the lower and upper third of the arm and whose distal end does not extend beyond the axillary vein. It requires the identification of the vein by ultrasound which reserves its installation for professionals trained and authorized to use the ultrasound scanner.
Midline is currently indicated for intravenous treatments > 7 days and in patients with precarious venous capital. According to the manufacturer's instructions, it can be kept in place for up to 30 days, while the recommendations of the Centers disease of control specify that this period could be extended to 49 days.
Its use is expanding rapidly in France, thus meeting the needs of patients who do not require a central line and whose use of a standard peripheral venous catheter is not possible (low venous capital or treatment duration > 7 days). Its installation, essentially carried out by qualified anaesthetists, does not increase medical planning and is therefore an attractive alternative to the installation of a central catheter whose complications (thrombosis and infections) are known.
The only data on the complication rate, estimated at 1-2%, are from low-potency observational studies. In the absence of high-level evidence, most of the good practice recommendations published in 2019 are based on expert consensus.
This leads us to conduct a large-scale observational study to assess the complication rate and identify the associated factors. This study will provide professionals with reliable scientific data for the next review of good practice recommendations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients concerned with this study requiring a midline for any indication and hospitalized in a department other than intensive care or intensive care.
Key inclusion criteria (3 listed)
- Adult patient
- No opposition to the study
- Patient requiring a midline
Key exclusion criteria (6 listed)
- Patient in Intensive Care Unit or acute care unit.
- Patient with a contra indication to midline insertion: arterio-venous fistula, history of axillary lymph node clearance or radiotherapy in the infusion arm, presence of infectious skin lesions near the infusion area, presence of a prosthesis on the infusion arm or hemiplegic arm.
- Patient under legal protection measure
- Patient already enrolled
- Minor patient;
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 |
|---|---|---|
| Follow up of midlinesThe follow-up data to be collected will be recorded on a monitoring logbook that will follow the patient (Appendix 4). The latter will be involved in the follow-up of his data insofar as he will be able to solicit the various professionals performing care on his midline in order to aim at the exhaustiveness of the filling of the book. | Other | – |
Primary outcome
assess numbers of adverse events
Time frame: through study completion, an average of 2 year
catheter related infection yes/no vein thrombosis yes/no occlusion yes/no exposition time to a midline catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 37463802Derouin Y, Le Thuaut A, Dauvergne J, Cinotti R, Cartron E. Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study). BMJ Open. 2023 Jul 18;13(7):e067796. doi: 10.1136/bmjopen-2022-067796.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thrombosis, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jun 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess numbers of adverse events (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131088, which also lists 1 linked publication.
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 27 Jun 2023.