Vascular Access ComplicationIMPROWENCT03976557
BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden
A study testing BIP CVC and Standard CVC in people with Vascular Access Complication and Catheter-Related Infections, run by Bactiguard AB at 1 site in Sweden.
Trial summary
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC. (CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Catheter-Related Infections, Catheter Thrombosis
- What is being tested?
- BIP CVC and Standard CVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 11 Apr 2019to 18 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication…)
- Fully recognize and understand patient information
- Signed informed consent
Who cannot join
- If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire
- Age < 18 years
- Pregnant women
- Known allergy to gold, silver and palladium
- Participation in other clinical studies which may interfere with this study as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
Read the detailed description
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
- Conditions
- Vascular Access Complication, Catheter-Related Infections, Catheter Thrombosis, Catheter Blockage, Catheter Complications, Catheter Site Discomfort
- Being tested
- BIP CVC, Standard CVC
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP CVCDevice
Also called Noble metal coated CVC
Central venous access with noble metal coated CVC
Standard CVCDevice
Also called Uncoated CVC
Central venous access with standard uncoated CVC
| Study group | Role | What they receive |
|---|---|---|
| BIP CVC | Experimental | Polyurethane CVC with noble metal coating Receives: Device: BIP CVC |
| Standard CVC | Active comparator | Standard CVC made of polyurethane Receives: Device: Standard CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with catheter related complications
Patients having any complication specified as secondary endpoints
Measured: From CVC insertion until CVC withdrawal
Secondary outcomes (9)
Number of patients with CRBSI
CRBSI - Catheter Related Blood Stream Infections
Measured: From CVC insertion until CVC withdrawal
Number of patients with CRI
CRI - Catheter Related Infections
Measured: From CVC insertion until CVC withdrawal
Number of patients with local CVC infections
Skin infection at the insertion site
Measured: From CVC insertion until CVC withdrawal
Number of CVC exchanges per patient due to suspected infection or thrombosis
Reported as incidence
Measured: From CVC insertion until CVC withdrawal
Number of patients with stop or slower flow in any CVC lumen
Stop or slower flow or need of high pressure during blood sample withdrawal and/or injection of solution
Measured: From CVC insertion until CVC withdrawal
Number of patients with local thrombosis
Local thrombosis - thrombosis in the insertion vein
Measured: From CVC insertion until CVC withdrawal
Number of patients with device malfunctions
Any device malfunction or technical problems during insertion, withdrawal or use
Measured: From CVC insertion until CVC withdrawal
Number of patients with antibiotics and antithrombotics drug use
including the reason of use and dose / number of days
Measured: From CVC insertion until CVC withdrawal
Number of patients with adverse events
including casuality assessment to the CVC use; both serious and non-serious
Measured: From CVC insertion until CVC withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start11 Apr 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Why it stopped: Due to Corona/Covid19 pandemic
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, randomized, open label, controlled trial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bactiguard AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danderyd Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Jakobsson, Prof, Principal investigator, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976557
- Sponsor's protocol ID
- PL-13732
- Acronym
- IMPROWE
- Status last verified
- Jan 2021
- First submitted
- 4 Jun 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
- ClinicalTrials.gov ID
- NCT03976557
- Acronym / sponsor ID
- IMPROWE / PL-13732
- Conditions
- Vascular Access Complication, Catheter-Related Infections, Catheter Thrombosis, Catheter Blockage, Catheter Complications, Catheter Site Discomfort
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Corona/Covid19 pandemic
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Bactiguard ABIndustry (pharma, biotech, devices)
- Collaborators
- Danderyd Hospital
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- 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.
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
Detailed description
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, randomized, open label, controlled trial
| Arm | Type | Receives |
|---|---|---|
| BIP CVC | Experimental | Device: BIP CVCPolyurethane CVC with noble metal coating |
| Standard CVC | Active comparator | Device: Standard CVCStandard CVC made of polyurethane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication…)
- Fully recognize and understand patient information
- Signed informed consent
Key exclusion criteria (5 listed)
- If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire
- Age < 18 years
- Pregnant women
- Known allergy to gold, silver and palladium
- Participation in other clinical studies which may interfere with this study as judged by the Investigator
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 |
|---|---|---|
| BIP CVCAlso: Noble metal coated CVCCentral venous access with noble metal coated CVC | Device | BIP CVC |
| Standard CVCAlso: Uncoated CVCCentral venous access with standard uncoated CVC | Device | Standard CVC |
Primary outcome
Number of patients with catheter related complications
Time frame: From CVC insertion until CVC withdrawal
Patients having any complication specified as secondary endpoints
9 secondary outcomes
Number of patients with CRBSI
Time frame: From CVC insertion until CVC withdrawal
Number of patients with CRI
Time frame: From CVC insertion until CVC withdrawal
Number of patients with local CVC infections
Time frame: From CVC insertion until CVC withdrawal
Number of CVC exchanges per patient due to suspected infection or thrombosis
Time frame: From CVC insertion until CVC withdrawal
Number of patients with stop or slower flow in any CVC lumen
Time frame: From CVC insertion until CVC withdrawal
Number of patients with local thrombosis
Time frame: From CVC insertion until CVC withdrawal
Number of patients with device malfunctions
Time frame: From CVC insertion until CVC withdrawal
Number of patients with antibiotics and antithrombotics drug use
Time frame: From CVC insertion until CVC withdrawal
Number of patients with adverse events
Time frame: From CVC insertion until CVC withdrawal
Results and safety
The study was stopped early (reason given: Due to Corona/Covid19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Vascular Access Complication
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
RecruitingObservational study
Mobilisation After Endovascular Stroke Treatment
Stroke, Acute Ischemic Stroke
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes
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.
Jan Jakobsson, Prof principal investigator
Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIP CVC and Standard CVC in people with Vascular Access Complication and Catheter-Related Infections, run by Bactiguard AB at 1 site in Sweden.
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 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: stopped early, as of the sponsor's last update on 22 Jan 2021. 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 Sweden. 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 was stopped early (reason given: Due to Corona/Covid19 pandemic). Results are not available in the source record.
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?
Number of patients with catheter related complications (time frame: From CVC insertion until CVC withdrawal). 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 22 Jan 2021.