Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000161628
Ethics application status
Approved
Date submitted
20/01/2023
Date registered
17/02/2023
Date last updated
17/02/2023
Date data sharing statement initially provided
17/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of cell salvage on blood transfusion rates in major hepatobiliary surgery
Scientific title
The impact of autologous blood transfusion on peri-operative allogenic blood transfusion in patients undergoing major hepatopancreatobiliary surgery: a retrospective cohort study.
Secondary ID [1] 308804 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal liver metastases 328755 0
IMPN pancreas 328756 0
HCC 328757 0
Condition category
Condition code
Surgery 325760 325760 0 0
Other surgery
Blood 325761 325761 0 0
Anaemia
Cancer 325762 325762 0 0
Biliary tree (gall bladder and bile duct)
Cancer 325763 325763 0 0
Liver
Cancer 325764 325764 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Information from a prospective database of 501 patients undergoing major hepatobiliary and pancreatic (HPB) HPB resection (2015–2022) were analysed. Patients who received cell salvage (n=264) were compared with those who did not (n=237).
a) data including demographics (age/gender/BMI/preoperative haemoglobin, haematocrit), operation type, postoperative outcomes and transfusion rates were all collected
b) electronic medical records were used to obtain the above data. Participants were not actively involved in our data collection (i.e. did not fill out any surveys, nor did they visit a clinic for a consultation.
Intervention code [1] 325254 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333607 0
Transfusion rates (transfusion events, number of red cells per patient)
Collected from electronic medical records.
Timepoint [1] 333607 0
5 days post op
Primary outcome [2] 333608 0
Correction of blood-loss tolerance breach
Calculated using Lemmens-Bernstein-Brodorsky formula
Data collected from electronic medical records.
Timepoint [2] 333608 0
5 days post op
Secondary outcome [1] 417732 0
Morbidity (Clavein-dindo complication rate)
Collected from electronic medical records, specifically post-operative ward round entries, and any complications or interventions recorded in the medical notes.
Timepoint [1] 417732 0
Length of admission until date of discharge, or readmission with a direct complication of initial surgery.

Eligibility
Key inclusion criteria
All HPB patients undergoing resection between 2015-2022
Minimum age
23 Years
Maximum age
78 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil (retrospective cohort study)

Study design
Purpose
Duration
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Non-autologous transfusion was assessed from the time of surgery to 5 days post-surgery, and blood loss tolerance was calculated using the Lemmens-Bernstein-Brodosky formula. Multivariate analysis was used to identify factors associated with allogenic blood transfusion avoidance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2022
Date of last participant enrolment
Anticipated
Actual
1/10/2022
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
501
Accrual to date
Final
501
Recruitment outside Australia
Country [1] 25220 0
United Kingdom
State/province [1] 25220 0
Oxford

Funding & Sponsors
Funding source category [1] 313125 0
Self funded/Unfunded
Name [1] 313125 0
UNFUNDED
Country [1] 313125 0
Primary sponsor type
Individual
Name
Mr Alex Gordon-Weeks
Address
Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE
Country
United Kingdom
Secondary sponsor category [1] 314708 0
Hospital
Name [1] 314708 0
Oxford University Hospitals
Address [1] 314708 0
Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE
Country [1] 314708 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312283 0
Oxford University Hospitals NHS Foundation Trust Clinical Improvements Division, Ulysses
Ethics committee address [1] 312283 0
Clinical Improvements Division, Ulysses
Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
Ethics committee country [1] 312283 0
United Kingdom
Date submitted for ethics approval [1] 312283 0
27/08/2022
Approval date [1] 312283 0
15/12/2022
Ethics approval number [1] 312283 0
Reference number 7809 Ver 1 Type 03 Approved Local Audit

Summary
Brief summary
We believe that our work is of interest to the general surgical community as a whole, as it covers the topical issue of patient blood management in major abdominal surgery.
In this retrospective cohort study we analyse the effect of cell salvage and intra-operative autologous blood transfusion on the outcome of 501 patients undergoing major hepatopancreatobiliary surgery. We find that use of cell salvage is associated with a significant reduction in absolute and average allogenic packed red cell transfusion and that both the use of cell salvage and correction of blood loss tolerance breach are independently associated with avoidance of transfusion.
Our centre has developed a unique and highly specialised cell salvage service consisting of cell salvage practitioners whose sole task during surgery is to monitor blood loss, assess coagulopathy and return of blood aspirated from the operative field at regular intervals throughout surgery. This practice attempts to ensure that physiological levels of oxygen delivery are maintained throughout complex hepatobiliary procedures and we believe that the development of this practice is responsible for the significant avoidance in blood transfusion that we see in the cell salvage population presented here. The development of such a service is relatively unique to the UK and ours is, by some margin, the largest series to date analysing cell salvage use in hepatopancreatobiliary surgery. As such, despite its retrospective nature, this will be the highest level of published evidence demonstrating benefit of the routine use of cell salvage for major hepatopancreatobiliary resectional surgery.
Trial website
Trial related presentations / publications
Public notes
Internal ethics approval sought and obtained, as this was a retrospective cohort research study, therefore, ethics approval was sought and obtained after "enrolment" of the first participant.

Contacts
Principal investigator
Name 124098 0
Mr Alex Gordon-Weeks
Address 124098 0
Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE
Country 124098 0
United Kingdom
Phone 124098 0
+447808030432
Fax 124098 0
Email 124098 0
[email protected]
Contact person for public queries
Name 124099 0
Alex Gordon-Weeks
Address 124099 0
Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE
Country 124099 0
United Kingdom
Phone 124099 0
+44300 304 7777
Fax 124099 0
Email 124099 0
[email protected]
Contact person for scientific queries
Name 124100 0
Alex Gordon-Weeks
Address 124100 0
Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE
Country 124100 0
United Kingdom
Phone 124100 0
+447808030432
Fax 124100 0
Email 124100 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.