Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

Focus of Study Clinical Trial

Official title:

Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971021
• Other study ID #: EPN Linkoping 2013/56-31
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: January 29, 2018
• Start date: April 2013

Study information

• Verified date: January 2018
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• cancer treatment with need for central venous access

• Age >18 yrs

• Suspected survival > 4 weeks

• Need of central venous access >4 weeks

Exclusion Criteria:

• Ongoing uncontrolled systemic infection

• Prescence of significant thrombosis/stenosis in arm or central veins

• Unability to communicate

• Probable upcoming need for dialysis fistula

Related Conditions & MeSH terms

• Focus of Study

Intervention

Device:
• PICC or subcutaneous venous port

Locations

Country	Name	City	State
Sweden	Dept of Oncology	Jönköping

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Ryhov County Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurence of catheter related venous thrombosis	regular follow-ups at month 1, 3, 6 and 12.	Upon clinical suspiscion during the one the patient i enrolled in the study