Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000565246
Ethics application status
Approved
Date submitted
9/04/2018
Date registered
13/04/2018
Date last updated
25/07/2019
Date data sharing statement initially provided
25/07/2019
Date results information initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
VALidation of a tool to score veIn AssessmeNTs (VALIANT) in adult whole blood donors
Scientific title
Protocol to validate the Australian Red Cross Blood Service vein score assessment tool (VSAT) in adult whole blood donors by measurement of the inter-rater reliability of the tool
Secondary ID [1] 294534 0
None
Universal Trial Number (UTN)
Trial acronym
VALIANT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Donation 307313 0
Condition category
Condition code
Other 306423 306423 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The VSAT is comprised of 3 questions that use a 5 point Likert-type scale to measure a blood donors vein for suitability for phlebotomy. The 3 questions assess Vein visibility, palpation and size and give it a score between 0 and 4. The scores from each question are then tallied to calculate the donor’s overall vein score out of 12. The vein assessment will be completed by qualified Australian Blood Donor Centre staff a 4 locations in NSW. Assessment will be completed on both the left and right arms (cubital fossa) of eligible blood donors who have provided verbal consent. Two different staff members will assess the one donor separately to determine interrater reliability. Staff members will be blinded to their paired assessors results. The first assessment will be conducted in the pre donation interview room approximately 5-10 min prior to donation and the second assessment will be conducted immediately before donation when the donor is sitting on the donor couch
Intervention code [1] 300833 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305438 0
Inter-rater reliability of the vein score assessment tool
Timepoint [1] 305438 0
5-10 minutes before blood donation
Secondary outcome [1] 345229 0
Association between vein scores and failed phlebotomy. Failed phlebotomy is assessed by direct observation by donor centre phlebotomists immediately before and after needle insertion
Timepoint [1] 345229 0
At the time of needle insertion on blood donor couch
Secondary outcome [2] 345230 0
Association between vein scores and needle dislodgement. Needle dislodgement is assessed by direct observation by donor centre phlebotomists after needle insertion for the duration of the donation
Timepoint [2] 345230 0
After needle insertion on blood donor couch
Secondary outcome [3] 345231 0
Association between vein scores and underweight donations (< 200ml). 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] 345231 0
Immediately after blood donation
Secondary outcome [4] 345232 0
Association between vein scores and incomplete donations (200-428ml). 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 [4] 345232 0
Immediately after blood donation
Secondary outcome [5] 345233 0
Association between vein scores and prolonged donation duration (>12 min). The length of a donation or how long a donation takes is measured at the end of the donation by the automated blood collection system and recorded by the phlebotomists in the donors electronic record
Timepoint [5] 345233 0
Immediately after blood donation
Secondary outcome [6] 345234 0
Association between vein scores and donor adverse events. Known adverse events include phlebotomy injures (e.g.: haematoma), 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 [6] 345234 0
less than 90 days from blood donation or before the date of the donors next blood donation if that date is sooner

Eligibility
Key inclusion criteria
Participant (Staff)
1. Qualified (successfully completed all Blood Service competencies) donor centre phlebotomist
2. Able and willing to provide written informed consent to participate

Participant (Donor)
1. Adults, greater than 18 years of age
2. New or experienced whole blood donor
3. Eligible for blood donation as per the current Guidelines for Selection of Blood Donors
4. Written consent for general donation and oral consent for having their vein scored twice by participating staff.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant (Staff)
1. Non-phlebotomy donor centre staff member
2. Currently participating in another Blood Service research study

Participant (Donor)
1. Donors eligible for sample only collections (sample only appointments or identified as sample only candidate during interview e.g: Low Hb donors for ferritin testing)
2. Donors undergoing apheresis collections

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2018
Actual
16/04/2018
Date of last participant enrolment
Anticipated
Actual
12/05/2018
Date of last data collection
Anticipated
Actual
12/05/2018
Sample size
Target
540
Accrual to date
Final
553
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299161 0
Charities/Societies/Foundations
Name [1] 299161 0
Australian Red Cross Blood Service
Country [1] 299161 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
Australia
Country
Australia
Secondary sponsor category [1] 298418 0
None
Name [1] 298418 0
Address [1] 298418 0
Country [1] 298418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300085 0
Australian Red Cross Blood Service Ethics Committee
Ethics committee address [1] 300085 0
C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 300085 0
Australia
Date submitted for ethics approval [1] 300085 0
06/11/2017
Approval date [1] 300085 0
19/12/2017
Ethics approval number [1] 300085 0
2017#32

Summary
Brief summary
Phlebotomy is a central task performed by the Blood Service for the collection of whole blood, plasma and platelets from its voluntary blood donors. Currently there are no publications regarding how to routinely and systematically assess donor veins and the impact vein quality has on the success of blood donation. In the last 12 months up to 4% of phlebotomies attempted were unsuccessful. In addition, inadequate venous access resulted in needle dislodgement, underweight collections, protracted bleed times, component discard and substantial wastage of blood collected. The purpose of this study is to formally validate an internally developed vein score assessment tool to assess a donor's vein suitability for phlebotomy. The study will examine the extent of inter-rater variability in vein assessment between phlebotomist's and determine whether a score at or below a certain level is predictive of failed phlebotomy, needle dislodgement, underweight donation and prolonged donation duration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82518 0
Dr Phillip Mondy
Address 82518 0
Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 82518 0
Australia
Phone 82518 0
+61 (2) 9234 2444
Fax 82518 0
Email 82518 0
pmondy@redcrossblood.org.au
Contact person for public queries
Name 82519 0
Ms Justine O'Donovan
Address 82519 0
Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 82519 0
Australia
Phone 82519 0
+61 (0)2 9234 2444
Fax 82519 0
Email 82519 0
BS_ClinicalTrials@redcrossblood.org.au
Contact person for scientific queries
Name 82520 0
Dr Phillip Mondy
Address 82520 0
Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 82520 0
Australia
Phone 82520 0
+61 (0)2 9234 2444
Fax 82520 0
Email 82520 0
pmondy@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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hirani R, O'Donovan J, Knight E, Bell B, Mondy P. ... [More Details]

Documents added automatically
No additional documents have been identified.