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Not yet recruitingNCT07643246TROMBOUpdated Jun 11, 2026

National Study on the Prevalence of Catheter-Related Venous Thrombosis

An observational study in Thrombosis and Venous Catheterization, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Thrombosis
  • Venous Catheterization

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients who do not provide informed consent for the ultrasound assessment.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Overall prevalence of catheter-related thrombosis

    Number of patients with CRT / total number of patients evaluated) × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

Secondary outcomes

  1. Symptomatic CRT

    (Number of CRT cases with ≥1 clinical sign / total number of CRT cases) × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

  2. Asymptomatic CRT

    (Number of CRT cases without clinical signs / total number of CRT cases) × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

  3. Superficial CRT

    Number of superficial CRT cases / total number of CRT cases) × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

  4. Deep CRT

    Number of deep CRT cases / total number of CRT cases) × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

  5. Prevalence by responsible service

    (Number of CRT cases in each service category / total number of patients evaluated in that service) × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

  6. Time from implantation to CRT diagnosis

    Mean, SD, median, and IQR (interquartile range) of elapsed days

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

  7. Distribution by implanting operator

    Number of CRT cases by implanting operator / total number of CRT cases × 100

    Time frame: From the beginning of the cutoff to the end of the cutoff at 4 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07643246
Lead sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators
Hospital del Mar Research Institute (IMIM), Althaia Xarxa Assistencial Universitària de Manresa
Responsible party
Gerez Acevedo (Inés Gerez Acevedo, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta) — Principal investigator
First posted
Jun 11, 2026
Start date
May 25, 2026 (estimated)
Primary completion
Jun 19, 2026 (estimated)
Completion
Jun 19, 2026 (estimated)
Last update
Jun 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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