ThrombosisTROMBONCT07643246
National Study on the Prevalence of Catheter-Related Venous Thrombosis
An observational study of Thrombosis and Venous Catheterization, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta.
Trial summary
The aim is to determine the prevalence of catheter-related thrombosis (CRT) in hospitalized patients carrying PICC, FICC, CICC, and midline catheters through a multicenter, standardized prevalence study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Venous Catheterization
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to 19 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted across the following centers: Complejo Hospitalario Universitario Nuestra Señora de Candelaria, Hospital del Mar, Hospital Sant Joan de Déu-Althaia, Hospital Universitari Joan XXIII, Hospital Universitario de Navarra, Hospital Universitario Doctor Josep Trueta, Hospital Universitario Donostia, Hospital Universitario Mutua Terrassa, Hospital Universitario Son Espases, Policlínica Gipuzkoa, and Hospital de Navarra. Participation will include hospital institutions with an Infusion and Vascular Access Unit (IVAU) that has institutionally recognized expertise in the detection of catheter-related thrombosis (CRT).
Who may be able to join
- All hospitalized patients aged ≥18 years from all hospital wards, including critical care units, who are carriers of a midline, FICC, PICC, or CICC catheter with a dwell time of at least 7 days will be included.
Who cannot join
- Patients who do not provide informed consent for the ultrasound assessment.
About this study
The aim is to determine the prevalence of catheter-related thrombosis (CRT) in hospitalized patients carrying PICC, FICC, CICC, and midline catheters through a multicenter, standardized prevalence study. To achieve this, a cross-sectional study with prospective data collection will be conducted, including, through consecutive sampling to minimize selection bias, all hospitalized patients over 18 years of age from both general wards and critical care units who have had one of these catheters in place for at least 7 days. During data collection, an ultrasound examination of the catheter insertion site will be performed in order to rule out the presence of thrombotic complications.
- Conditions
- Thrombosis, Venous Catheterization
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall prevalence of catheter-related thrombosis
Number of patients with CRT / total number of patients evaluated) × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Secondary outcomes (7)
Symptomatic CRT
(Number of CRT cases with ≥1 clinical sign / total number of CRT cases) × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Asymptomatic CRT
(Number of CRT cases without clinical signs / total number of CRT cases) × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Superficial CRT
Number of superficial CRT cases / total number of CRT cases) × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Deep CRT
Number of deep CRT cases / total number of CRT cases) × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Prevalence by responsible service
(Number of CRT cases in each service category / total number of patients evaluated in that service) × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Time from implantation to CRT diagnosis
Mean, SD, median, and IQR (interquartile range) of elapsed days
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Distribution by implanting operator
Number of CRT cases by implanting operator / total number of CRT cases × 100
Measured: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completion19 Jun 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Althaia Xarxa Assistencial Universitària de Manresa
- Responsible party
- Principal investigator, Gerez Acevedo, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643246
- Sponsor's protocol ID
- TROMBO2025.109
- Acronym
- TROMBO
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Study on the Prevalence of Catheter-Related Venous Thrombosis
- ClinicalTrials.gov ID
- NCT07643246
- Acronym / sponsor ID
- TROMBO / TROMBO2025.109
- Conditions
- Thrombosis, Venous Catheterization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Althaia Xarxa Assistencial Universitària de Manresa
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 19 Jun 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 11 Jun 2026 (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.
The aim is to determine the prevalence of catheter-related thrombosis (CRT) in hospitalized patients carrying PICC, FICC, CICC, and midline catheters through a multicenter, standardized prevalence study. To achieve this, a cross-sectional study with prospective data collection will be conducted, including, through consecutive sampling to minimize selection bias, all hospitalized patients over 18 years of age from both general wards and critical care units who have had one of these catheters in place for at least 7 days. During data collection, an ultrasound examination of the catheter insertion site will be performed in order to rule out the presence of thrombotic complications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted across the following centers: Complejo Hospitalario Universitario Nuestra Señora de Candelaria, Hospital del Mar, Hospital Sant Joan de Déu-Althaia, Hospital Universitari Joan XXIII, Hospital Universitario de Navarra, Hospital Universitario Doctor Josep Trueta, Hospital Universitario Donostia, Hospital Universitario Mutua Terrassa, Hospital Universitario Son Espases, Policlínica Gipuzkoa, and Hospital de Navarra. Participation will include hospital institutions with an Infusion and Vascular Access Unit (IVAU) that has institutionally recognized expertise in the detection of catheter-related thrombosis (CRT).
Key inclusion criteria (1 listed)
- All hospitalized patients aged ≥18 years from all hospital wards, including critical care units, who are carriers of a midline, FICC, PICC, or CICC catheter with a dwell time of at least 7 days will be included.
Key exclusion criteria (1 listed)
- Patients who do not provide informed consent for the ultrasound assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall prevalence of catheter-related thrombosis
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Number of patients with CRT / total number of patients evaluated) × 100
7 secondary outcomes
Symptomatic CRT
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Asymptomatic CRT
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Superficial CRT
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Deep CRT
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Prevalence by responsible service
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Time from implantation to CRT diagnosis
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Distribution by implanting operator
Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Venous Catheterization, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta.
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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Overall prevalence of catheter-related thrombosis (time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks). 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 Jun 2026.