ClinicalTrials.gg
RecruitingNCT05743738THROMBOSEPUpdated Jun 15, 2023

Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

An interventional study of Doppler ultrasound in Septic Thrombophlebitis, sponsored by Centre Hospitalier le Mans. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death.

Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis.

The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature.

When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial.

Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.

02

Conditions studied

  • Septic Thrombophlebitis

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Keywords

  • septic thrombophlebitis
  • Doppler ultrasound
03

In context

Thrombophlebitis

15 studies on the registry are indexed under Thrombophlebitis; 2 are open to participants now.

This study's planned enrollment of 120 is above the median of 104 across 11 interventional studies indexed under Thrombophlebitis.

Browse Thrombophlebitis studies →

Lead sponsor

Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysis catheter) or a Midline and having catheter-related bacteremia
  • Catheter-related bacteremia according to the following definition (ePOPI): Positive blood cultures within 48 hours of a suspected catheter infection (or its removal) With one of the following criteria: - Before catheter removal: differential time of positivity of central/peripheral blood cultures ≥ 2 hours
  • After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the same organism.
  • Patient transportable for ultrasound or ultrasound can be performed in the patient's bed
  • Patient capable of giving consent, or consent of the trusted person for patients not capable of giving consent at the time of inclusion
  • Written consent signed by the participant and the investigator
  • Person affiliated to social security

Exclusion criteria

Exclusion Criteria:

  • Patient with a of less than one month
  • to anticoagulation
  • Patient already on curative anticoagulant therapy for any indication
  • Minor or adult patient under guardianship or protected or deprived of liberty
  • Pregnant, nursing or parturient woman
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Presence of thrombosis

    Doppler ultrasound D8, D15, D30, D45, D60 and D90

    Diagnostic Test: Doppler ultrasound

  • No intervention
    Absence of thrombosis

Interventions

  • Diagnostic testDoppler ultrasound

    Control venous Doppler ultrasound

06

What researchers measure

Primary outcomes

  1. Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline

    the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound

    Time frame: Day 90

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05743738
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Feb 24, 2023
Start date
May 31, 2023
Primary completion
May 31, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jun 15, 2023

Study contacts

Christelle JADEAU
Contact
cjadeau@ch-lemans.fr
+33244710781

Oversight

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

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