Received: 27 September 2023 Revised: 5 January 2024 Accepted: 6 January 2024

DOI: 10.1111/trf.17738

HOW DO I DO IT

How do we achieve blinding in modern electronic and

paper medical records during the conduct of transfusion
trials?

Sean Santos 1 | Akash Gupta 2 | Alan Tinmouth 3,4 | Amir Butt 5 |

Brian Berry 6,7 | Charles Musuka 8 | Christine Cserti-Gazdewich 9,10 |
Elaine Leung 11,12 | Jennifer Duncan 13 | Johnathan Mack 14 |
Matthew T. S. Yan 6,15,16 | Mohammad Bahmanyar 6,17 | Nadine Shehata 9,18 |
Oksana Prokopchuk-Gauk 19,20 | Rodrigo Onell 6,17 | Susan Nahirniak 21,22 |
Thomas Covello 6,16 | Yulia Lin 9,23 | Ziad Solh 24,25 | Jeannie Callum 26 |
Andrew W. Shih 1,6

Correspondence
Andrew W. Shih, Vancouver General
Hospital, Jim Pattison Pavilion North,
899 W 12th Ave, Vancouver, BC V5Z
1M9, Canada.
Email: andrew.shih@medportal.ca
Abstract
Background: Regulatory aspects of transfusion medicine add complexity in
blinded transfusion trials when considering various electronic record keeping
software and blood administration processes. The aim of this study is to
explore strategies when blinding transfusion components and products in
paper and electronic medical records.
Methods: Surveys were collected and interviews were conducted for 18 sites
across various jurisdictions in North America to determine solutions applied
in previous transfusion randomized control trials.
Results: Sixteen responses were collected of which 11 had previously partici-
pated in a transfusion randomized control trial. Various solutions were
reported which were specific to the laboratory information system (LIS) and
electronic medical record (EMR) combinations although solutions could be
grouped into four categories which included the creation of a study product
code in the LIS, preventing the transmission of data from the LIS to the EMR,
utilizing specialized stickers and labels to conceal product containers and doc-
uments in the paper records, and modified bedside procedures and
documentation.
Discussion: LIS and EMR combinations varied across sites, so it was not pos-
sible to determine combination-specific solutions. The study was able to

Abbreviations: ALBICS, ALBumin In Cardiac Surgery; EMR, electronic medical record; LIS, laboratory information system; RCT, randomized
control trials.
For affiliations refer to page 433

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any
medium, provided the original work is properly cited and is not used for commercial purposes.
© 2024 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.

428 wileyonlinelibrary.com/journal/trf Transfusion. 2024;64:428–437.


SANTOS ET AL.
highlight solutions that may be emphasized in future iterations of LIS and
EMR software as well as procedural changes that may minimize the risk of
unblinding.
KEYWORDS
health research methodology, regulatory and QA, transfusion practices (adult)
1 | INTRODUCTION
Randomized control trials (RCT) are considered studies
with the greatest methodological rigor due to designs that
limit bias such as blinding which limits bias from partici-
pants, researchers, and outcome assessors.1 Blinding is
often feasible to implement in clinical trials involving
pharmaceutical drugs through the use of various methods
including placebos and dummy procedures.2 Blinding
can be challenging in transfusion-related clinical trials as
Health Canada and the Food and Drug Administration
(FDA) regulate transfusion practices in Canada and the
United States (US), respectively, and mandate stringent
labeling and traceability of blood components (red blood
cells, plasma, platelets, and cryoprecipitate) and products
(e.g., albumin, fibrinogen concentrate, and prothrombin
complex concentrate) and their containers.3–5 In Canada,
plasma-derived blood products are managed by blood
banks and are treated similarly to blood components with
respect to regulatory requirements. In the United States,
blood components are also managed by blood banks but
fractionated blood products may be dispensed by phar-
macies and blood banks which is an additional challenge
in achieving successful blinding. Transfusion-related clin-
ical practice is also a consideration as blood components
vary in volume and appearance and often require trans-
parent documentation in the patient's medical chart.
While necessary, such regulations and practices can
increase the risk of unblinding throughout several phases
of a RCT, especially as transfusion records are increas-
ingly being retained electronically through laboratory
information systems (LIS) as the “source of truth” and
transmitted across to the electronic medical records
(EMR) to minimize paper documentation.
Many transfusion RCTs have been conducted such as
the ALBumin In Cardiac Surgery (ALBICS)6 trial and
Effect of fibrinogen concentrate versus cryoprecipitate on
blood component transfusion after cardiac surgery
(FIBRES)7 trial, where issued blood products were blinded
in the EMR while still adhering to regulations regarding
traceability in the blood bank. Different LIS/EMR combi-
nations may be utilized at each site which means blinding
of blood products and components is a site-specific chal-
lenge that may require solutions specific to the capabilities
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429
of LIS/EMR combinations and site procedures. A literature
review based on knowledge and review of recent transfu-
sion trials and a limited literature search was conducted
(Appendix 2). It was revealed that a small number of publi-
cations describing blinding methods for blood products
such as fibrinogen concentrate, but only reported methods
for blinding the blood product itself through the use of con-
cealed vials and opaque syringes.7–9 The FIBRES study7
could not feasibly blind clinicians administering the study
products (fibrinogen concentrate and cryoprecipitate) due
to marked differences in color and product containers
(glass vial vs. plastic container), although specialized
blinded labels were used in patient charts to blind the out-
come assessors. The ALBICS trial utilized opaque tubing
covers as well as priming with the patient's own blood in
order to mask the distinct appearance of albumin, as com-
pared with crystalloid.6 The literature we reviewed did not
describe solutions for blinding within the EMR and trans-
fusion records retained in patient charts in studies for both
blood products and components, with the latter being gen-
erally open-label.10 The primary purpose of this project is
to explore solutions and challenges for the blinding of
blood products in transfusion RCTs with respect to EMR
and LIS combinations and clinical bedside documentation.
2 | METHODS
We developed a seven-question online survey using Qual-
trics XM (Seattle, Washington, USA) and identified 18 aca-
demic sites across Canada and the United States
(15 Canadian, 3 US States) that may have participated in
transfusion RCTs requiring blinding through purposive
sampling. Some Canadian provinces were considered a
single site if operating under a single health organization
with a consolidated EMR, although their jurisdiction
included multiple acute care centers. Sites were notified
regarding the planned survey and then sent a subsequent
online survey by email (Appendix 1). Follow-up emails
were sent to nonresponders to maximize response rate.
Nonresponders were also offered the alternative option of
completing the structured survey live via an online one-
on-one interview which was conducted for a single site.
The respondents were asked to specify which LIS and
 15372995, 2024, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/trf.17738 by National Health And Medical Research Council, Wiley Online Library on [21/04/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
430 SANTOS ET AL.

EMR software were used at their site and if the site had
participated in an RCT that required the issuing of blood
products with blinding to health care teams, patients, or
outcome assessors. Finally, the respondents were
prompted to describe how blinding was maintained
between the blood bank LIS and EMR, as well as on the
hard copy transfusion records retained in the patient's
chart, if applicable. A modified survey was utilized for the
US sites to include the name of the pharmacy system if
the pharmacy issued blinded blood products at their site.
3 | RESULTS
A total of 16 survey responses were received (14 Canadian
sites and 2 US sites) between October 2022 and February
2023. A variety of LIS and EMR combinations were
reported across all sites with some sites reporting the use
of multiple software due to the presence of several cen-
ters in their jurisdiction (Table 1). Eleven sites had previ-
ously participated in transfusion RCTs that required
blinding. All 11 sites described solutions for either

T A B L E 1 Reported solutions for blinding by laboratory information system (LIS)/electronic medical record (EMR) combinations from
each responding site.

New
Blood Bank Participated in product LIS did not Specialized Instructions for
LIS/pharmacy blinded transfusion code transmit labels/ blinded
Site system EMR RCT? (yes/No) created to EMR stickers documentation
Site Wellsky Cerner Epic Sunrise Yes ✓
A Millennium Clinical
Manager
Site Wellsky Epic Sunrise Yes ✓ ✓
B Labvision Clinical
Site Cerner Cerner Yes ✓
C Millennium Millennium
Site Sunquest Cerner Yes ✓ ✓ ✓
D Laboratory Millennium
Site Wellsky Sunnycare Yes ✓ ✓ ✓ ✓
E
Site Sunquest CareConnect Yes ✓
F Laboratory
Site Wellsky Epic Yes ✓ ✓ ✓ ✓
G
Site Meditech Meditech Yes ✓ ✓
H
Site Sunquest QuadraMed Yes ✓ ✓
I Laboratory
Site Meditech OU Meditech Yes ✓ ✓
J Medicine
Pharmacy
Site Traceline E-Chart Yes ✓ ✓
K
Site Softbank (SCC) Cerner No
L Millennium
Site Cerner Epic No
M Millennium
Site Softbank (SCC) Allscripts No
N
Site Cerner Cerner No
O Millennium Millennium
Site Haemonetics Epic No
P Safetrace
 15372995, 2024, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/trf.17738 by National Health And Medical Research Council, Wiley Online Library on [21/04/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
SANTOS ET AL. 431

LIS/EMR blinding, paper chart record blinding, or both
which were categorized into four generalized solutions
shown in Table 1.
For blinding between the LIS and EMR, six sites cre-
ated a new “study” product code. In most cases, the novel
“study” code would mean the issued blood component/
product type was not explicitly revealed in the patient's
transfusion history or it was not readily accessible in the
EMR. Six sites did not transmit transfusion product infor-
mation from the LIS to the EMR. Six sites blinded trans-
fusion chart records using specialized transfusion labels
and stickers, most in conjunction with some degree of
instruction for blinded documentation for care providers.
The use of labels to blind product containers and paper
records and instructions for blinded documentation
address blinding the chart records and transfusion-
related documentation such as residual paper documents,
charting, and ins-outs volumes. For most sites, this
involved instructing the clinical team to avoid accessing
transfusion history modules in their respective EMRs.
Some sites issued instructions for health care teams on
how to record in and out volumes of transfused products,
opting to record the total fluid balance volume at the con-
clusion of the procedure instead of volume per compo-
nent/product transfusion. Two sites were able to utilize
all four solutions due to the capabilities of their LIS and
the cooperation of the clinical staff.
4 | DISCUSSION
4.1 | Generalized solutions
The results highlight the challenges that arise in blinding
transfusion components/products due to the variety of
LIS/EMR combinations used across research sites, which
is highly relevant to international jurisdictions with simi-
lar regulatory requirements and the increasing use of
LIS/EMR systems. Each LIS and EMR software combina-
tion has different capabilities and limitations, different
implementations of the software, and site-specific pro-
cesses and workflows which must be considered to deter-
mine the feasibility of blinding. As solutions may not
necessarily be tied to specific LIS/EMR combinations, we
endeavored to report solutions in four categories which
could be considered for future trials (Figure 1). To
address blinding in the LIS and EMR, the two solutions
included the creation of a new “study” component/
product code and/or inhibiting the transmission of the
transfusion activity from the LIS to the EMR. To address

F I G U R E 1 Blinding solutions per site and corresponding transfusion trials. Visual representation of each sites blinding solutions
categorized by the four generalized solutions. Generalized solutions divided into two categories indicating blinding in electronic medical
record (EMR)/laboratory information system (LIS) and chart record. Each responding site is de-identified and a legend indicates which
transfusion trials the site(s) participated in. CONCOR1,10 ARIPI,11 FIBRES,7 FARES-1,12 FARES-2,13 FiiRST-2.14 [Color figure can be viewed
at wileyonlinelibrary.com]

432
blinding in the paper chart, the two solutions included
specialized transfusion labels/stickers and instructions to
clinical care teams on blinded documentation though
adherence to specialized workflows outside of the stan-
dard of care can be difficult to achieve, and therefore the
latter solution is suboptimal.
4.2 | Comparison with other reports
There is a lack of similar reports discussing LIS and EMR
blinding methods as applicable to contemporary transfu-
sion trials. Previous trials reported ad hoc blinding
methods which often varied between participating sites
dependent on laboratory and clinical capacities.6,7,10
Blinding of the physical blood product during prepara-
tion and administration was a focus in many reports
while blinding the LIS/EMR was rarely reported or dis-
cussed.8,9 When taking pharmaceutical trials into
account, there is also a lack of publications which
reported blinded electronic documentation.2 Most
publications focused on product concealment, blinding of
outcome assessors, and use of placebo and dummy proce-
dures rather than the transmission of data into patient
health records.2
F I G U R E 2 Flowchart of blinding issues in various phases of a transfusion trial and related solutions. Figure representing the various
challenges with blinding at each stage of the transfusion trial workflow and related solutions for each. EMR, electronic medical record; LIS,
laboratory information system. [Color figure can be viewed at wileyonlinelibrary.com]
15372995, 2024, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/trf.17738 by National Health And Medical Research Council, Wiley Online Library on [21/04/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
SANTOS ET AL.
4.3 | Next steps
Many considerations must be made in order to more
effectively blind future transfusion trials (Figure 2). Due
to the importance of traceability between LIS and
EMRs, sites must carefully consider the capabilities of
both systems should blinding be required for a trial,
especially during the purchase and implementation
phase of these systems. Through this work, we advocate
for future iterations of LIS and EMR software to include
features such as the ability to easily create study codes
and options for temporarily blocking product informa-
tion in the EMR until completion of trial follow-up pro-
cedures and publication of the trial results. These are
features that software vendors can implement in order
to improve their future modules to assist research
design. Such built-in features could reduce human
resources in achieving stringent blinding protocols for
those administering investigational products to ulti-
mately ease the bedside record keeping process. It may
also be worthwhile to consider possible concealment
options that may be applied during product preparation
or administration. Consideration of concealment
options would depend on the product type and the
capacity of the care providers to further complicate

SANTOS ET AL.
transfusion processes as additional steps would be
required to prepare the product for transfusion.
4.4 | Limitations
The recommendations reported may lack generalizability
due to the variations of LIS/EMR combinations between
sites, though accounted for by providing broad categories
of solutions rather than technical or workflow specific
solutions. However, they may be achievable to varying
degrees depending on the capabilities of a given
LIS/EMR combination and the individual site's processes.
A limited number of sites were surveyed within Canada
and the United States; the authors acknowledge that
other jurisdictions not surveyed may have superior blind-
ing processes that are not accounted for. The results may
not be relevant to jurisdictions outside of Canada and the
United States as the survey focused on sites within these
countries and their respective LIS/EMR systems which
may not be as prevalent in other jurisdictions. Further
data from other jurisdictions may bolster the generaliz-
ability of the results and help to disseminate creative
solutions to tighten blinding procedures for future trans-
fusion trials.
5 | C ON C L U S I ON
As more transfusion trials are being conducted there is a
growing need for effective research methodology with
respect to blinding. The preparation, administration, and
documentation of blood products is a heavily regulated
process in Canada and the United States. Blinding pre-
sents a myriad of methodological challenges to
researchers with the movement toward transparent elec-
tronic record keeping between blood bank LIS and
EMRs. The discussion surrounding possible solutions to
these challenges is in its early stages and would benefit
from further exploration, particularly in jurisdictions out-
side of this study's scope.
A FF IL I AT I O N S
1
Department of Pathology and Laboratory Medicine,
Vancouver Coastal Health Authority, Vancouver, British
Columbia, Canada
2
Department of Laboratory Medicine and Pathobiology,
Sunnybrook Health Science Centre, Toronto, Ontario,
Canada
3
Benign Hematology and Transfusion Medicine, Division
of Hematology, Ottawa Hospital, Ottawa, Ontario,
Canada
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433
4
OHRI Centre for Transfusion Research, Clinical
Epidemiology Program, Ottawa Hospital Research
Institute, Ottawa, Ontario, Canada
5
Department of Anesthesiology, University of Oklahoma
Health Sciences Center, Oklahoma City, Oklahoma, USA
6
Department of Pathology and Laboratory Medicine,
University of British Columbia, Vancouver, British
Columbia, Canada
7
Department of Pathology, Royal Jubilee Hospital,
Victoria, British Columbia, Canada
8
Department of Transfusion Medicine, Shared Health
Manitoba, Winnipeg, Manitoba, Canada
9
Department of Laboratory Medicine and Pathobiology,
University of Toronto, Toronto, Ontario, Canada
10
Blood Transfusion Laboratory and Blood Disorders
Clinic (Division of Medical Oncology and Hematology),
University Health Network, Toronto, Ontario, Canada
11
Division of Hematology and Transfusion Medicine,
Children's Hospital of Eastern Ontario, Ottawa, Ontario,
Canada
12
Department of Pathology and Laboratory Medicine,
University of Ottawa, Ottawa, Ontario, Canada
13
Vancouver Island Health Authority, Courtenay, British
Columbia, Canada
14
Department of Medicine, Ottawa General Hospital,
University of Ottawa, Ottawa, Ontario, Canada
15
Canadian Blood Services, Vancouver, British Columbia,
Canada
16
Fraser Health Authority, New Westminster, British
Columbia, Canada
17
Department of Pathology and Laboratory Medicine, St.
Paul's Hospital, Providence Health Care, Vancouver,
British Columbia, Canada
18
Department of Laboratory Medicine and Pathology,
Mount Sinai Hospital, Toronto, Ontario, Canada
19
Department of Pathology and Laboratory Medicine,
University of Saskatchewan, Saskatoon, Saskatchewan,
Canada
20
Saskatchewan Health Authority, Saskatoon,
Saskatchewan, Canada
21
Department of Laboratory Medicine and Pathology,
Faculty of Medicine, University of Alberta, Edmonton,
Alberta, Canada
22
Transfusion and Transplantation Medicine, Alberta
Precision Laboratories, Edmonton, Alberta, Canada
23
Division of Transfusion Medicine and Tissue Bank,
Sunnybrook Health Sciences Centre, Toronto, Ontario,
Canada
24
Department of Pathology and Laboratory Medicine,
University of Western Ontario, London, Ontario, Canada
25
Transfusion Medicine Laboratories, London Health
Sciences Centre, London, Ontario, Canada

434
26
Department of Pathology and Molecular Medicine,
Kingston Health Sciences Centre, Queen's University,
Kingston, Ontario, Canada
CONFLICT OF INTEREST STATEMENT
AT has received funding for research support from Cana-
dian Blood Services and the Canadian Institutes for
Health Research (CIHR); honoraria from Bristol Squib
Meyers. OPG has received consulting fees from Takeda
Canada and Octapharma Canada; honoraria from Cana-
dian Blood Services. SN is a member of the AABB
ICTMG Platelet Clinical Practice Guidelines Steering
Committee. YL has received funding for research support
from Canadian Blood Services and Octapharma Canada
and is a consultant for Choosing Wisely Canada. JC has
received funding for research support from Canadian
Blood Services and Octapharma Canada. AWS has
received funding for research support from Canadian
Blood Services and the Canadian Institutes for Health
Research (CIHR); honoraria from Octapharma Canada
and Canadian Blood Services.
ORCID
Akash Gupta https://orcid.org/0000-0001-6838-2576
Amir Butt https://orcid.org/0000-0002-4802-4162
Christine Cserti-Gazdewich https://orcid.org/0000-0002-
5297-6406
Oksana Prokopchuk-Gauk https://orcid.org/0000-0003-
2758-714X
Yulia Lin https://orcid.org/0000-0002-5562-9020
Ziad Solh https://orcid.org/0000-0002-1518-1831
Andrew W. Shih https://orcid.org/0000-0001-7107-2595
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How to cite this article: Santos S, Gupta A,
Tinmouth A, Butt A, Berry B, Musuka C, et al.
How do we achieve blinding in modern electronic
and paper medical records during the conduct of
transfusion trials? Transfusion. 2024;64(3):428–37.
https://doi.org/10.1111/trf.17738
 15372995, 2024, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/trf.17738 by National Health And Medical Research Council, Wiley Online Library on [21/04/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
SANTOS ET AL. 435

A P P END I X 1 : ONLINE SURVEY QUESTIONS 3. Softbank (SCC)

SENT TO PARTICIPATING SITES 4. Sunquest Laboratory
5. Traceline
6. WellSky
Please select the centre/jurisdiction you represent (select 7. Other (Specify below)
below) iv. If your LIS is not listed above, please enter
the name below
1. Please select the centre/jurisdiction you represent 1. Free text box
(select below)
a. Site A 3. Please enter the name of the pharmacy system utilized
b. Site B at your site
c. Site C a. Free text box
d. Site D 4. Please select the electronic medical record (EMR) soft-
e. Site E ware that is utilized at your centre
f. Site F a. Allscripts
g. Site G b. CareConnect
h. Site H c. Cerner Millenium
i. Site I d. Epic
j. Site J e. MEDITECH
k. Site K f. PCIS
l. Site L g. Other (Specify below)
m. Site M i. If your EMR software is not listed above,
n. Site N please enter the name below
o. Site O 1. Free text box
p. Other (Specify below)
2. Please select the laboratory information system 5. Has your centre participated in a Canadian RCT that
(LIS) that is currently utilized at your centre's required the issuing of blood products in a blinded
Blood Bank manner? (Examples of Canadian RCTs: FARES,
a. Cerner Millenium FIIRST, FiiRST-2, FIBRES)
b. MEDITECH (i.e., Magic, EXPANSE, client server) a. Yes
c. Softbank (SCC) b. No
d. Sunquest Laboratory 6. How did you maintain blinding from blood products
e. Traceline issued in the LIS and recorded in the EMR? Please
f. WellSky type your answer in the field below.
g. Other (Specify below) a. Free text box
i. If your LIS is not listed above, please enter 7. How did you maintain blinding from the patient's
the name below chart in which transfusion records are documented?
1. Free text box Please type your answer in the field below.
ii. Do you plan to transition to a new Blood a. Free text box
Bank LIS in the next 2 years? 8. If we wished to know more about your processes,
1. Yes could you identify someone on your team who we
2. No could engage with? – Name
iii. Please specify which Blood Bank LIS you a. Free text box
plan to transition to. 9. If we wished to know more about your processes,
1. Cerner Millenium could you identify someone on your team who we
2. MEDITECH (i.e., Magic, EXPANSE, cli- could engage with?—Email Address
ent server) a. Free text box
 15372995, 2024, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/trf.17738 by National Health And Medical Research Council, Wiley Online Library on [21/04/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
436 SANTOS ET AL.

A P P END I X 2 : SUMMARY OF LITERATURE REVIEW

Literature reviewed includes recent and large randomized controlled trials in transfusion medicine:

EMR blinding
Trial instructions specified?
1 MINT trial: Carson JL, Brooks MM, Hébert PC, et al; MINT Investigators. Restrictive or Liberal Not specified
Transfusion Strategy in Myocardial Infarction and Anemia. N Engl J Med. 2023 Nov 11. doi: 10.
1056/NEJMoa2307983. Epub ahead of print. PMID: 37952133.
2 FOCUS trial: Carson JL, Terrin ML, Noveck H, et al; FOCUS Investigators. Liberal or restrictive Not specified
transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453–62.
doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14. PMID: 22168590; PMCID: PMC3268062.
3 TRICS trial: Mazer CD, Whitlock RP, Fergusson DA, et al; TRICS Investigators and Perioperative Not specified
Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery.
N Engl J Med. 2017 Nov 30;377(22):2133–2144. doi: 10.1056/NEJMoa1711818. Epub 2017 Nov 12.
PMID: 29130845.
4 PACER trial: van Baarle FLF, van de Weerdt EK, van der Velden WJFM, et al. Platelet Transfusion Not specified
before CVC Placement in Patients with Thrombocytopenia. N Engl J Med. 2023 May 25;388
(21):1956–1965. doi: 10.1056/NEJMoa2214322. PMID: 37224197.
5 FIBRES trial: Callum J, Farkouh ME, Scales DC, et al; FIBRES Research Group. Effect of Not specified
Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac
Surgery: The FIBRES Randomized Clinical Trial. JAMA. 2019 Nov 26;322(20):1966–1976. doi: 10.
1001/jama.2019.17312. PMID: 31634905; PMCID: PMC6822637.
6 PLANET-2 trial: Curley A, Stanworth SJ, Willoughby K, et al; PlaNeT2 MATISSE Collaborators. Not specified
Randomized Trial of Platelet-Transfusion Thresholds in Neonates. N Engl J Med. 2019 Jan 17;380
(3):242–251. doi: 10.1056/NEJMoa1807320. Epub 2018 Nov 2. PMID: 30387697.
7 CONCOR-1 trial: Bégin P, Callum J, Jamula E, et al; CONCOR-1 Study Group; Arnold DM. Not specified
Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized
controlled trial. Nat Med. 2021 Nov;27(11):2012–2024. doi: 10.1038/s41591-021-01488-2. Epub
2021 Sep 9. Erratum in: Nat Med. 2022 Jan;28(1):212. PMID: 34504336; PMCID: PMC8604729.
8 FARES Trial: Karkouti K, Bartoszko J, Grewal D, et al. Comparison of 4-Factor Prothrombin Not specified except
Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After investigational product
Cardiac Surgery: A Randomized Pilot Trial. JAMA Netw Open. 2021 Apr 1;4(4):e213936. doi: 10. was not recorded in the
1001/jamanetworkopen.2021.3936. PMID: 33792729; PMCID: PMC8017469. patient chart
9 CRYOSTAT-2: Davenport R, Curry N, Fox EE, et al; CRYOSTAT-2 Principal Investigators. Early Not specified
and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The
CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882–1891. doi: 10.1001/
jama.2023.21019. PMID: 37824155; PMCID: PMC10570921.
10 RePHILL trial: Crombie N, Doughty HA, Bishop JRB, et al; RePHILL collaborative group. Not specified
Resuscitation with blood products in patients with trauma-related haemorrhagic shock receiving
prehospital care (RePHILL): a multicentre, open-label, randomised, controlled, phase 3 trial.
Lancet Haematol. 2022 Apr;9(4):e250-e261. doi: 10.1016/S2352-3026(22)00040-0. Epub 2022 Mar
7. PMID: 35271808; PMCID: PMC8960285.
11 PAMPER trial: Sperry JL, Guyette FX, Brown JB, et al; PAMPer Study Group. Prehospital Plasma Not specified
during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med.
2018 Jul 26;379(4):315–326. doi: 10.1056/NEJMoa1802345. PMID: 30044935.
12 ORACL trial: Mullis BH, Mullis LS, Kempton LB, Virkus W, Slaven JE, Bruggers J. Orthopaedic Not specified
Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective
Randomized Study. J Orthop Trauma. 2024 Jan 1;38(1):18–24. doi: 10.1097/BOT.
0000000000002696. PMID: 38093439.
 15372995, 2024, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/trf.17738 by National Health And Medical Research Council, Wiley Online Library on [21/04/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
SANTOS ET AL. 437

EMR blinding
Trial instructions specified?
13 TOP NIRS trial: Chock VY, Kirpalani H, Bell EF, et al; Eunice Kennedy Shriver National Institute Not specified
of Child Health and Human Development Neonatal Research Network. Tissue Oxygenation
Changes After Transfusion and Outcomes in Preterm Infants: A Secondary Near-Infrared
Spectroscopy Study of the Transfusion of Prematures Randomized Clinical Trial (TOP NIRS).
JAMA Netw Open. 2023 Sep 5;6(9):e2334889. doi: 10.1001/jamanetworkopen.2023.34889. PMID:
37733345; PMCID: PMC10514737.
14 1VERSUS2CGR trial: Chantepie SP, Mear JB, Briant AR, et al. Effect of single-unit transfusion in Not specified
patients treated for haematological disease including acute leukemia: A multicenter randomized
controlled clinical trial. Leuk Res. 2023 Jun;129:107058. doi: 10.1016/j.leukres.2023.107058. Epub
2023 Mar 18. PMID: 37080000.
15 PROCOAG trial: Bouzat P, Charbit J, Abback PS, et al; PROCOAG Study Group. Efficacy and Not specified
Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With
Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial. JAMA. 2023
Apr 25;329(16):1367–1375. doi: 10.1001/jama.2023.4080. PMID: 36942533; PMCID:
PMC10031505.
16 REALITY: Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, et al. Effect of a Restrictive vs Liberal Not specified
Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute
Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial. JAMA. 2021;325
(6):552–560. doi:10.1001/jama.2021.0135
17 FIDEL: Ducloy-Bouthors AS, Mercier FJ, Grouin JM, et al. Early and systematic administration of Not specified
fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL
randomised controlled trial. BJOG. 2021;128(11):1814–1823. doi:10.1111/1471-0528.16699, 10.
1111/1471-0528.16699
18 TRIBE: Palmieri TL, Holmes JH 4th, Arnoldo B, et al. Transfusion Requirement in Burn Care Not specified
Evaluation (TRIBE): A Multicenter Randomized Prospective Trial of Blood Transfusion in Major
Burn Injury. Ann Surg. 2017;266(4):595–602. doi:10.1097/SLA.0000000000002408, 10.1097/SLA.
0000000000002408