Condition category
Not Applicable
Date applied
13/03/2013
Date assigned
16/05/2013
Last edited
25/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to compare two kinds of catheters (thin tubes inserted into the body for treatment or surgery): a central venous catheter (CVC) and peripherally inserted central venous catheter (PICC) which is inserted in a vein in the arm instead of a vein in the neck or chest.

Who can participate?
Both male and female patients, who are over 18 years of age, in need of a central venous catheter, who have received information on the study and have given the consent for this study.

What does the study involve?
In-patients and out-patients who are referred to the department for gastrointestinal cancer treatment in Sahlgrenska University Hospital (Sweden).

What are the possible benefits and risks of participating?
There are no known risks. The treatment with these catheters is well documented and well known.

Where is the study run from?
Sahlgrenska University Hospital, Gothenburg, Sweden

When is the study starting and how long is it expected to run for?
The study takes place between January 2013 and December 2015.

Who is funding the study?
Scholarships

Who is the main contact?
Dr Cecilia Engström
cecilia.engstrom@surgery.gu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cecilia Engström

ORCID ID

Contact details

Sahlgrensk University Hostpital/SS
Goteborg
41345
Sweden
cecilia.engstrom@surgery.gu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised clinical trial on venous access comparing central venous catheter and peripher inserted central venous catheter

Acronym

CVC, PICC

Study hypothesis

PICC line use is more safe, with less side-effects and adverse events and perhaps also less expensive and easier to use both for patients and medical personal.

Ethics approval

Board of Ethics in Goteborg, 2011-09-11, ref: Dnr 492-11

Study design

Randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Upper GI disease

Intervention

Patients are enrolled as indoor and outdoor patients and randomised in a way approved before and after patients consent. The specific catheter is inserted by either a specialised nurse or doctor.
Arm 1: CVC treatment
Arm 2: PICC line

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Catheter treatment period: measured in 2014/15 approximately

Secondary outcome measures

Side effects such as thrombosis, thromophlebitis, pneumothorax, hemothorax, deep and surface infections: measured in 2014/15 approximately

Overall trial start date

01/01/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or Female over 18 yrs in need of a central line
2. Patient has received information of the study and consent is given

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 250 patients

Participant exclusion criteria

Patient who has no need of central venous access

Recruitment start date

01/01/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrensk University Hostpital/SS
Goteborg
41345
Sweden

Sponsor information

Organisation

Sahlgrenska University Hospital (Sweden)

Sponsor details

Sahlgrenska University Hospital/SS
Goteborg
41345
Sweden
cecilia.engstrom@surgery.gu.se

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Sahlgrenska University Hospital (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes