NCT02489721

Brief Summary

Most important peripherally inserted central catheter (PICC) and Midline complications are thrombosis and catheter related blood stream infections. No large prospective observational study are present in literature about these topics. The aim of this multicenter prospective observational study is to analyze all the complications due to PICC and Midline insertion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4.6 years

First QC Date

June 30, 2015

Last Update Submit

January 9, 2020

Conditions

Upper Extremity Deep Vein Thrombosis

Keywords

peripherally inserted central venous catheterdepp vein thrombosisrelated blood stream infectionsmidline

Outcome Measures

Primary Outcomes (1)

  • Prevalence of deep venous thrombosis (DVT) occurring after the PICC placement in all patients

    2 years

Secondary Outcomes (4)

  • Prevalence of infections related catheter

    2 years

  • Prevalence of other complications such as phlebitis, occlusion, malposition

    2 years

  • Reason of the catheter removal

    2 years

  • Prevalence of the same complications Midline related

    2 years

Interventions

PICC and MidlineDEVICE

Peripherally inserted central venous catheter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted in all the patients undergoing PICC or Midline catheter insertion which fall in the inclusion criteria

You may qualify if:

  • all patients aged 18-90 years (oncological, malignancy hematology, medical, surgical and critically ICU patients) in whom it was determined that PICC/Midline insertion was indicated.

You may not qualify if:

  • renal insufficiency whose creatinine level was greater than 3.0 mg/dL or who were undergoing hemodialysis,
  • preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results);
  • preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, Antithrombin deficiency, lupus anticoagulant);
  • axillary lymphonodi dissection or alteration of lymphatic drainage;
  • PICC and/or Midline insertion in a paretic arm;
  • patients who had been previously enrolled in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Santa Maria della Misericordia

Udine, 33100, Italy

Location

Related Publications (2)

  • Greene MT, Flanders SA, Woller SC, Bernstein SJ, Chopra V. The Association Between PICC Use and Venous Thromboembolism in Upper and Lower Extremities. Am J Med. 2015 Sep;128(9):986-93.e1. doi: 10.1016/j.amjmed.2015.03.028. Epub 2015 May 1.

    PMID: 25940453RESULT

  • Chopra V, Fallouh N, McGuirk H, Salata B, Healy C, Kabaeva Z, Smith S, Meddings J, Flanders SA. Patterns, risk factors and treatment associated with PICC-DVT in hospitalized adults: A nested case-control study. Thromb Res. 2015 May;135(5):829-34. doi: 10.1016/j.thromres.2015.02.012. Epub 2015 Feb 21.

    PMID: 25726426RESULT

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Livia Pompei, MD

    AOU Santa Maria della Misericordia

    PRINCIPAL INVESTIGATOR

  • Giorgio Della Rocca, MD

    AOU Santa Maria della Misericordia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 3, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

IT(1)