Adult Patients With Peripherally Inserted Central CathetersPRISM-1NCT01578993

Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters

An observational study of Adult Patients With Peripherally Inserted Central Catheters, run by Teleflex at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult Patients With Peripherally Inserted Central Catheters
How many people: 101 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Oct 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients necessitating insertion of a PICC for fluid, nutritional, chemotherapy or antibiotic treatment for a minimum of 14 days.

Who may be able to join

Male or Female Age > 18 years requiring central venous access
Ability to comply with study requirements
Written Informed Consent

Who cannot join

Previous enrollment in study
Current or recent upper extremity thrombosis, occlusion or stenosis
Previous axillary lymph node dissection
Skin inflammatory condition or rashes within 15 cm from insertion site
Pre-existing history of hypercoagulability unrelated to malignant disease
Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies
Positive blood culture within 48 hours from planned PICC placement
Known, renal insufficiency with chronic creatinine levels > 1.7 mg/dl

Trial locations and contacts

1 site in 1 country.

United States1 site

Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.

The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.

Conditions: Adult Patients With Peripherally Inserted Central Catheters

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of PICC Line Occlusions
The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.
Measured: Insertion to Removal / maximum 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Oct 2013

First posted17 Apr 2012 (estimated)
Study startAug 2012
Primary completionJun 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adult Patients With Peripherally Inserted Central CathetersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01578993
Sponsor's protocol ID: S-PICC 2012-01
Acronym: PRISM-1
Status last verified: May 2014
First submitted: 12 Apr 2012
Last updated: 16 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.
ClinicalTrials.gov ID: NCT01578993
Acronym / sponsor ID: PRISM-1 / S-PICC 2012-01
Conditions: Adult Patients With Peripherally Inserted Central Catheters
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: TeleflexIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Jun 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 17 Apr 2012 (estimated)
Results: Posted 24 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients necessitating insertion of a PICC for fluid, nutritional, chemotherapy or antibiotic treatment for a minimum of 14 days.

Key inclusion criteria (3 listed)

Male or Female Age > 18 years requiring central venous access
Ability to comply with study requirements
Written Informed Consent

Key exclusion criteria (8 listed)

Previous enrollment in study
Current or recent upper extremity thrombosis, occlusion or stenosis
Previous axillary lymph node dissection
Skin inflammatory condition or rashes within 15 cm from insertion site
Pre-existing history of hypercoagulability unrelated to malignant disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Rate of PICC Line Occlusions
Time frame: Insertion to Removal / maximum 3 months
The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.

Results and safety

Results posted to the registry on 24 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm Study	101	101

Primary outcome: Rate of PICC Line Occlusions

Time frame: Insertion to Removal / maximum 3 months. Number. Unit: percentage of enrolled subjects

Measure	Single Arm Study n = 101
Value	37

Adverse events

Time frame: This observationaol study included recording of line occlusions and incidence of venous thrombosis from the time of PICC insertion until removal of the PICC line or for a maximum of 90 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm Study	0 of 101 (0%)	6 of 101 (5.9%)	Not reported

Limitations and caveats (from the sponsor): Further comparative studies standarizing the management of PICC line flushing solutions and type if PICC line required to provide comparative and evidence based clinical practice recommendations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Adult Patients With Peripherally Inserted Central Catheters, run by Teleflex at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of PICC Line Occlusions (time frame: Insertion to Removal / maximum 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.