Vascular Access ComplicationNCT02405728
Vascular Access in Hematological Patients - PICC Versus CVC
A study testing Centrally inserted central catheters (CICCs) and Peripherally inserted central catheters (PICCs) in people with Vascular Access Complication, run by Federico II University at 1 site in Italy.
Trial summary
The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- Centrally inserted central catheters (CICCs) and Peripherally inserted central catheters (PICCs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 yrs
- Newly diagnosed AML
- Suspected survival > 4 weeks
- Need of central venous access >4 weeks
Who cannot join
- Ongoing uncontrolled systemic infection
- Presence of significant thrombosis/stenosis in arm or central veins
- Diagnosis of another cancer within 12 months before AML onset
- any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy
- Unability to communicate and/or to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Access in Hematological Patients - PICC Versus CVC in a Phase IV Randomized Controlled Trial
The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (CICCs).
Read the detailed description
The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism. These complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. Evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs is unknown. An understanding of this risk in the context of growing PICC use is an important cost and patients safety questions. Up to now, no systematic review has been done to investigate these questions.
- Conditions
- Vascular Access Complication
- Being tested
- Centrally inserted central catheters (CICCs), Peripherally inserted central catheters (PICCs)
- Keywords
- PICC, BLOODSTREAM INFECTIONS, VASCULAR ACCESS, DEEP VEIN THROMBOSIS, CICC
- Medical subject headings
- Sepsis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centrally inserted central catheters (CICCs)Device
Randomization between two well established clinical routine vascular access devices
Peripherally inserted central catheters (PICCs)Device
Randomization between two well established clinical routine vascular access devices
| Study group | Role | What they receive |
|---|---|---|
| Peripherally inserted central catheters | Experimental | Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs Receives: Device: Peripherally inserted central catheters (PICCs) |
| Centrally inserted central catheter | Active comparator | Centrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs Receives: Device: Centrally inserted central catheters (CICCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-related bloodstream infections
- Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.
Measured: 1 year
Secondary outcomes (1)
Other complications
- Occurrence of complications associated with catheter positioning (serious bleeding, arterial puncture and/or pneumothorax), catheter malfunctions (dislocation, occlusion and/or rupture), catheter removals and 30-days overall mortality.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Picardi, Federico II University
- Investigators
- Marco Picardi, Prof, Principal investigator, Hematology - AOU Federico II - Napoli - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405728
- Sponsor's protocol ID
- HEM-FEDII-PICC-001
- Status last verified
- Apr 2018
- First submitted
- 13 Mar 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access in Hematological Patients - PICC Versus CVC in a Phase IV Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02405728
- Acronym / sponsor ID
- HEM-FEDII-PICC-001
- Conditions
- Vascular Access Complication
- Keywords
- PICC, BLOODSTREAM INFECTIONS, VASCULAR ACCESS, DEEP VEIN THROMBOSIS, CICC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (CICCs).
Detailed description
The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism. These complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. Evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs is unknown. An understanding of this risk in the context of growing PICC use is an important cost and patients safety questions. Up to now, no systematic review has been done to investigate these questions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripherally inserted central catheters | Experimental | Device: Peripherally inserted central catheters (PICCs)Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs |
| Centrally inserted central catheter | Active comparator | Device: Centrally inserted central catheters (CICCs)Centrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 yrs
- Newly diagnosed AML
- Suspected survival > 4 weeks
- Need of central venous access >4 weeks
Key exclusion criteria (5 listed)
- Ongoing uncontrolled systemic infection
- Presence of significant thrombosis/stenosis in arm or central veins
- Diagnosis of another cancer within 12 months before AML onset
- any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy
- Unability to communicate and/or to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centrally inserted central catheters (CICCs)Randomization between two well established clinical routine vascular access devices | Device | Centrally inserted central catheter |
| Peripherally inserted central catheters (PICCs)Randomization between two well established clinical routine vascular access devices | Device | Peripherally inserted central catheters |
Primary outcome
Catheter-related bloodstream infections
Time frame: 1 year
1. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.
1 secondary outcome
Other complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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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.
Marco Picardi, Prof principal investigator
Hematology - AOU Federico II - Napoli - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centrally inserted central catheters (CICCs) and Peripherally inserted central catheters (PICCs) in people with Vascular Access Complication, run by Federico II University at 1 site in Italy.
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 4 inclusion and 5 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 10 Apr 2018. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Catheter-related bloodstream infections (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2018.