None listed
Conditions
Brief summary
Australia relies on volunteers to fulfil its blood donation requirements. The number of potential donors is constrained by strict donor eligibility criteria necessarily imposed to ensure the safety of the donor and of the blood supply. Not all volunteers who present to donate have veins which are easy to see and feel. Recent findings from the VALIANT Trial using independent assessment of donor vein suitability for successful phlebotomy found that only 50% of donors were assessed as having easily visible and palpable veins; the phlebotomy success rate in these donors was 98% (P. Mondy MD, et al unpublished data August 2018). However, 12% of donors were assessed as having veins which were difficult to see and to feel, and 25% of donors in this group experienced a failed phlebotomy. In donors with intermediate vein visibility and palpability scores, the phlebotomy success rate was 92% (P. Mondy MD, et al unpublished data August 2018). Recent knowledge exchanges with international blood operators have identified that significant improvement in phlebotomy success rates can be achieved with the use of a skin marking device to assist phlebotomists locate the position and direction of veins after the skin disinfection has occurred, when re-palpation is not possible. The use of permanent markers to identify the site of surgery / invasive procedures is standard practice in most clinical settings and forms part of the surgical safety procedures both locally and internationally. To date there is no published data on the use of surgical skin markers in a blood donation setting. The following study proposes to determine if a single use sterile skin marker used to indicate the location and direction of a preferred vein prior to venepuncture increases the rate of phlebotomy success. A single use sterile skin marker will be used for the trial in order to minimise any source of nosocomial infection transmission between donors.
Interventions
The AMS single-use, sterile, skin marker is a Class Is medical device and is listed on the Australian Register for Therapeutic Goods (ARTG 303940). Each pen is single use and will be disposed of after use by donor centre staff.
Trained donor centre staff will select the most suitable vein for phlebotomy, looking at size / visibility / palpation and noting any donor preference. Blood Pressure cuff will be applied and inflated to 40-60 mmHg, arm will be re-palpated arm and the most suitable vei
The AMS single-use, sterile, skin marker is a Class Is medical device and is listed on the Australian Register for Therapeutic Goods (ARTG 303940). Each pen is single use and will be disposed of after use by donor centre staff. Trained donor centre staff will select the most suitable vein for phlebotomy, looking at size / visibility / palpation and noting any donor preference. Blood Pressure cuff will be applied and inflated to 40-60 mmHg, arm will be re-palpated arm and the most suitable vein selected. Sterile skin marker packet will be opened, arm palpated again, and a line gently drawn (1.5cm) above and below the point of needle entry. A small break will be left in the line made – this is the point of needle entry. Cuff is to be deflated and skin marker ink left to dry for 1 minute before application of skin disinfectant. Once the skin marker ink has dried, site will be disinfected as per standard of care using SoluPrep(TM) and venepuncture will occur as per standard operating procedures.
Sponsors
Australian Red Cross Blood Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
CLUSTERS 1. A mean phlebotomy success rate of less than 95% 2. Sufficient size to recruit over 700 donors over a month 3. Static Donor Centres PARTICIPANTS 1. Adults greater than 18 years of age 2. Eligible for blood donation as per the current 'Guidelines for the Selection of Blood Donors'
Exclusion criteria
CLUSTER 1. Plasma only donor centres 2. Donor Mobile units (DMUs) and Demountable mobile units 3. Participation in another research study (R&D or Marketing) that may interfere with donor recruitment and the outcomes under investigation 4. Donor Services Leadership team consider the donor centre not appropriate for participation (e.g.: centre undergoing renovations, relocation) PARTICIPANTS 1. Donors booked for sample only collections and ineligible to proceed to donation (e.g.: ABMDR, HOH, venous ferritin) 2. Known sensitivity to Gentian violet and or other topical disinfectants 3. Donors who decline use of the skin marker
Outcome results
None listed