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

• Sponsor: Linkoeping University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01971021
• Collaborator: Ryhov County Hospital (Other)
• Enrollment: 400
• Location: 1
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Focus of Study	Device: PICC or subcutaneous venous port	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: open label pragmaticopen label pragmatic
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jan 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PICC-line PICC line insertion.	Device: PICC or subcutaneous venous port
Active Comparator: PORT Subcutaneous venous port insertion	Device: PICC or subcutaneous venous port

Outcome Measures

Primary Outcome Measures

1. The occurence of catheter related venous thrombosis [Upon clinical suspiscion during the one the patient i enrolled in the study]

   regular follow-ups at month 1, 3, 6 and 12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Oncology	Jönköping		Sweden	551 11

Sponsors and Collaborators

• Linkoeping University
• Ryhov County Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Knut Taxbro, MD Consultant in Anesthesia and Intensive Care, Linkoeping University
• ClinicalTrials.gov Identifier: NCT01971021
• Other Study ID Numbers: EPN Linkoping 2013/56-31
• First Posted: Oct 28, 2013
• Last Update Posted: Jan 30, 2018
• Last Verified: Jan 1, 2018

Study Results

No Results Posted as of Jan 30, 2018