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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

15/09/2020

Date data sharing statement initially provided

22/11/2018

Date results provided

15/09/2020

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Blood Donation

Condition category

Condition code

Other

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]

Treatment: Devices

Comparator / control treatment

Control: No Surgical Skin Marker device prior to venepuncture (standard of care)

Control group

Active

Outcomes

Primary outcome [1]

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]

At the time of needle insertion

Secondary outcome [1]

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]

After needle insertion on blood donation couch

Secondary outcome [2]

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]

Immediately after blood donation

Secondary outcome [3]

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]

Immediately after blood donation

Secondary outcome [4]

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]

from start to finish of the blood donation

Secondary outcome [5]

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]

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

Sex

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

10/12/2018

Actual

18/12/2018

Date of last participant enrolment

Anticipated

10/06/2019

Actual

13/02/2019

Date of last data collection

Anticipated

12/06/2019

Actual

14/02/2019

Sample size

Target

13730

Accrual to date

Final

13730

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Red Cross Blood Service

Address [1]

National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Red Cross Blood Service Ethics Committee

Ethics committee address [1]

C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2018

Approval date [1]

20/11/2018

Ethics approval number [1]

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

Dr Barbara Bell

Address

Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015

Country

Australia

Phone

+61 (0)2 9234 2444

Fax

bbell@redcrossblood.org.au

Contact person for public queries

Name

Elizabeth Knight

Address

Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 (0)3 9863 1600

Fax

BS_ClinicalTrials@redcrossblood.org.au

Contact person for scientific queries

Name

Barbara Bell

Address

Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015

Country

Australia

Phone

+61 (0)2 9234 2444

Fax

bbell@redcrossblood.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
378	Ethical approval					376434-(Uploaded-21-11-2018-15-26-16)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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