SurgeryPhase 4NCT02811380
BIP CVC Clinical Safety and Performance Study
A Phase 4 study testing BIP CVC and Uncoated Standard CVC in people with Surgery and Central Line Associated Blood Stream Infections (CLABSI), run by Bactiguard AB at 1 site in Sweden.
Trial summary
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Central Line Associated Blood Stream Infections (CLABSI)
- What is being tested?
- BIP CVC and Uncoated Standard CVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Jan 2015
- Phase
- Phase 4
- 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
- Adult men and women ≥ 18 years of age
- Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial
- Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days
- Had signed the informed consent
Who cannot join
- Known transmissive blood disease
- Known multiresistant bacterial colonization
- Ongoing infection
- Thromboembolism
- Anti-coagulation treatment excluding prophylaxis
- CVC during last 2 months
- History of problems with CVC
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden
Stockholm, Huddinge, SE-141 86
About this study
Official title: Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
Read the detailed description
The primary objective of this study is to determine the safety for the medical device of 'BIP central venous catheter". Safety is assessed by evaluation of adverse events (according to ISO 14155:2011). Examples of CVC related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax.
The secondary objective is to assess the overall performance by evaluating if there were any CVC handling problems experienced by the physician/health care personnel.
Furthermore, an exploratory objective of this study is to assess coating and microbial colonization.
Included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned CVC catheterization in right or left jugular vein or subclavian vein planned for at least 3 days.
This study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of BIP CVC with noble metal alloy coating.
All statistical analyses is performed using the SAS® System, version 9.3 or higher (SAS Institute Inc., Cary, NC, USA). Data is to be summarized using descriptive statistics.
- Being tested
- BIP CVC, Uncoated Standard CVC
- Keywords
- CVC, Healthcare associated infections (HAI), CLABSI, Noble metal alloy coating, CVC related thrombosis
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP CVCDevice
Also called BIP Central Venous Catheter, Bactiguard coated CVC, Noble metal alloy coated Central Venous Catheter
BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
Uncoated Standard CVCDevice
Also called Standard CVC, Standard Central Venous Catheter, Uncoated CVC, Uncoated Central Venous Catheter
Standard CVC catheterization for venous access during and after elective large surgery
| Study group | Role | What they receive |
|---|---|---|
| BIP CVC | Experimental | Bactiguard Infection Protection Central Venous Catheter Receives: Device: BIP CVC |
| Uncoated standard CVC | Placebo comparator | Uncoated standard Central Venous Catheter Receives: Device: Uncoated Standard CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
Measured: Through study completion, an average of 10 days
Secondary outcomes (1)
Assessment of the overall performance
Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel.
Measured: Through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bactiguard AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Sigridur Kalman, MD PhD Prof, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811380
- Sponsor's protocol ID
- 2535-2030-CDOC
- Status last verified
- Jun 2016
- First submitted
- 23 Dec 2014
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
- ClinicalTrials.gov ID
- NCT02811380
- Acronym / sponsor ID
- 2535-2030-CDOC
- Keywords
- CVC, Healthcare associated infections (HAI), CLABSI, Noble metal alloy coating, CVC related thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bactiguard ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jun 2016 (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 primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
Detailed description
The primary objective of this study is to determine the safety for the medical device of 'BIP central venous catheter". Safety is assessed by evaluation of adverse events (according to ISO 14155:2011). Examples of CVC related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax.
The secondary objective is to assess the overall performance by evaluating if there were any CVC handling problems experienced by the physician/health care personnel.
Furthermore, an exploratory objective of this study is to assess coating and microbial colonization.
Included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned CVC catheterization in right or left jugular vein or subclavian vein planned for at least 3 days.
This study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of BIP CVC with noble metal alloy coating.
All statistical analyses is performed using the SAS® System, version 9.3 or higher (SAS Institute Inc., Cary, NC, USA). Data is to be summarized using descriptive statistics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIP CVC | Experimental | Device: BIP CVCBactiguard Infection Protection Central Venous Catheter |
| Uncoated standard CVC | Placebo comparator | Device: Uncoated Standard CVCUncoated standard Central Venous Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women ≥ 18 years of age
- Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial
- Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days
- Had signed the informed consent
Key exclusion criteria (8 listed)
- Known transmissive blood disease
- Known multiresistant bacterial colonization
- Ongoing infection
- Thromboembolism
- Anti-coagulation treatment excluding prophylaxis
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: BIP Central Venous Catheter, Bactiguard coated CVC, Noble metal alloy coated Central Venous CatheterBIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery | Device | BIP CVC |
| Uncoated Standard CVCAlso: Standard CVC, Standard Central Venous Catheter, Uncoated CVC, Uncoated Central Venous CatheterStandard CVC catheterization for venous access during and after elective large surgery | Device | Uncoated standard CVC |
Primary outcome
Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
Time frame: Through study completion, an average of 10 days
Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
1 secondary outcome
Assessment of the overall performance
Time frame: Through study completion, an average of 10 days
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 23 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Sigridur Kalman, MD PhD Prof principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BIP CVC and Uncoated Standard CVC in people with Surgery and Central Line Associated Blood Stream Infections (CLABSI), 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 4 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 23 Jun 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. (time frame: Through study completion, an average of 10 days). 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 23 Jun 2016.