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Trial registered on ANZCTR


Registration number
ACTRN12618001904268
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
22/11/2018
Date last updated
11/03/2019
Date data sharing statement initially provided
22/11/2018
Date results information initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of whether a surgical skin marker used to indicate the location of the most suitable vein for blood donation is appropriate for use with blood donors in Australia
Scientific title
A cluster randomised controlled trial to evaluate the impact using a sterile surgical skin marker, to indicate the location of the optimal vein for venepuncture, has on Phlebotomy success in the Australian blood donation setting
Secondary ID [1] 296675 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Donation 310519 0
Condition category
Condition code
Other 309232 309232 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312987 0
Treatment: Devices
Comparator / control treatment
Control: No Surgical Skin Marker device prior to venepuncture (standard of care)
Control group
Active

Outcomes
Primary outcome [1] 308199 0
Difference in Phlebotomy success rates between the intervention and control group. Phlebotomy success is assessed by direct observation by donor centre phlebotomists immediately before and after needle insertion

Data will be obtained through linkage to Blood Service Records
Timepoint [1] 308199 0
At the time of needle insertion
Secondary outcome [1] 354217 0
Difference between Intervention group and Control Group in number of Needle dislodgements. Needle dislodgement is assessed by direct observation by donor centre phlebotomisits after needle insertion for the duration of the donation,
Timepoint [1] 354217 0
After needle insertion on blood donation couch
Secondary outcome [2] 354218 0
Difference between intervention and control groups in number of underweight donations (less than 200ml whole blood, less than 100ml plasma/ platelets). The weight of collections are measured at the end of the donation by the automated blood collection system and recorded by the phlebotomists in the donors electronic record
Timepoint [2] 354218 0
Immediately after blood donation
Secondary outcome [3] 354219 0
Difference between intervention and control groups in number of sub-optimal donations (200 - 428ml whole blood, less than 75% of target plasma volume or less than 550ml platelets). The weight of collections are measured at the end of the donation by the automated blood collection system and recorded by the phlebotomists in the donors electronic record
Timepoint [3] 354219 0
Immediately after blood donation
Secondary outcome [4] 354220 0
Difference between intervention and control groups in number of prolonged donations (greater than 12 minutes for whole blood, greater than 60min for plasma volume and greater than 90 minutes for platelet collections). The time taken for each collection is measured from the start of the donation by the automated blood collection system until completion or early termination and recorded by the phlebotomists in the donors electronic record
Timepoint [4] 354220 0
from start to finish of the blood donation
Secondary outcome [5] 354221 0
Difference between intervention and control groups in the number of donor adverse events. Known adverse events include phlebotomy injures (e.g.: haematoma), localised infections and vasovagal reactions (e.g.: Fainting). DAEs will be recorded either directly by donor centre staff present during the donation or reported directly by the donor post donation to our national call centre.
Timepoint [5] 354221 0
Immediately after blood donation or within 24 hours after donation if a delayed reaction occurs

Eligibility
Key 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'
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Donor Collection Centres (Cluster) will be randomised via a Simple randomisation scheme using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster Randomised trial
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD

Funding & Sponsors
Funding source category [1] 301254 0
Charities/Societies/Foundations
Name [1] 301254 0
Australian Red Cross Blood Service
Address [1] 301254 0
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country [1] 301254 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 300891 0
None
Name [1] 300891 0
Address [1] 300891 0
Country [1] 300891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301995 0
Australian Red Cross Blood Service Ethics Committee
Ethics committee address [1] 301995 0
C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 301995 0
Australia
Date submitted for ethics approval [1] 301995 0
16/11/2018
Approval date [1] 301995 0
20/11/2018
Ethics approval number [1] 301995 0
Bell 19112018

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88794 0
Dr Barbara Bell
Address 88794 0
Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 88794 0
Australia
Phone 88794 0
+61 (0)2 9234 2444
Fax 88794 0
Email 88794 0
bbell@redcrossblood.org.au
Contact person for public queries
Name 88795 0
Ms Elizabeth Knight
Address 88795 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 88795 0
Australia
Phone 88795 0
+61 (0)3 9863 1600
Fax 88795 0
Email 88795 0
BS_ClinicalTrials@redcrossblood.org.au
Contact person for scientific queries
Name 88796 0
Dr Barbara Bell
Address 88796 0
Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 88796 0
Australia
Phone 88796 0
+61 (0)2 9234 2444
Fax 88796 0
Email 88796 0
bbell@redcrossblood.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 378 0
Citation [1] 378 0
Link [1] 378 0
Email [1] 378 0
Other [1] 378 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary