A Study to Assess the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- La Crosse, Wisconsin: 19-007287
NCT ID: NCT04048863
Sponsor Protocol Number: US-N-H-1801
About this study
The purpose of this study is to evaluate ways to reduce the number of complications (problems) related to inserting a catheter (a small flexible tube) into a vein in an individual's hand or arm, and to increase the length of time that it remains in place to treat your medical condition.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or female aged ≥ 18 years.
- The subject or the subject's LAR voluntarily agrees that the subject will participate in this study and is able to understand and sign the Informed Consent Form (ICF).
- Have a medical condition that requires a PIVC anticipated to last for at least 48 hours.
- Have intact skin at the site of insertion.
- If the patient has an existing IV in one arm he/she must have a viable contralateral arm for additional PIVC insertion.
Exclusion Criteria:
- Are currently participating in another medical device or pharmaceutical study.
- In the opinion of the Investigator, would not be suitable candidates for this study.
- The subject or his/her LAR is an employee of the Investigator or study center or the sponsor.
- Are an employee of the Investigator or study center, have direct involvement in the study or other studies under the direction of that Investigator or study center, or are a family member of the employees or the Investigator.
- Patient has an existing non-study related IV.
- Have a laboratory confirmed bloodstream infection within 48 hours prior to participation in the study. The assessment is based on clinical observations and not routine for all subjects.
- Patient has an existing IV in one arm and has a medical condition prohibiting contralateral PIVC insertion.
- Was removed from any Stage of the study due to an AE associated with the PIVC.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
La Crosse, Wis.
Mayo Clinic principal investigator Camilla Jaekel, D.Phil., R.N., AGCNS-BC |
Closed for enrollment |
|
More information
Publications
Publications are currently not available