ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Colorectal liver metastases

IMPN pancreas

HCC

Condition category

Condition code

Surgery

Other surgery

Blood

Anaemia

Cancer

Biliary tree (gall bladder and bile duct)

Cancer

Liver

Cancer

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Transfusion rates (transfusion events, number of red cells per patient)
Collected from electronic medical records.

Timepoint [1]

5 days post op

Primary outcome [2]

Correction of blood-loss tolerance breach
Calculated using Lemmens-Bernstein-Brodorsky formula
Data collected from electronic medical records.

Timepoint [2]

5 days post op

Secondary outcome [1]

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]

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?

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]

United Kingdom

State/province [1]

Oxford

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

UNFUNDED

Address [1]

UNFUNDED

Country [1]

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]

Hospital

Name [1]

Oxford University Hospitals

Address [1]

Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Oxford University Hospitals NHS Foundation Trust Clinical Improvements Division, Ulysses

Ethics committee address [1]

Clinical Improvements Division, Ulysses
Oxford University Hospitals NHS Foundation Trust 
John Radcliffe Hospital
Headley Way
Headington
Oxford 
OX3 9DU

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

27/08/2022

Approval date [1]

15/12/2022

Ethics approval number [1]

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

Mr Alex Gordon-Weeks

Address

Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE

Country

United Kingdom

Phone

+447808030432

Fax

alex.gordonweeks@gmail.com

Contact person for public queries

Name

Alex Gordon-Weeks

Address

Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE

Country

United Kingdom

Phone

+44300 304 7777

Fax

lauren.stubbs@ouh.nhs.uk

Contact person for scientific queries

Name

Alex Gordon-Weeks

Address

Department of hepatobiliary surgery
Churchill hospital
Old Rd, Headington, Oxford
OX3 7LE

Country

United Kingdom

Phone

+447808030432

Fax

alex.gordonweeks@gmail.com

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?

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.

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