Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000167561
Ethics application status
Approved
Date submitted
10/01/2024
Date registered
22/02/2024
Date last updated
23/06/2024
Date data sharing statement initially provided
22/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
If a patient’s own blood is reinfused during major lifesaving cancer surgery, can modern technology reduce the risks of infection and cancer dissemination.
Scientific title
Does intraoperative cell salvage with a leucodepletion filter reduce the exposure risk to cancer cells and infection during pelvic exenteration surgery?
Secondary ID [1] 311292 0
None
Universal Trial Number (UTN)
Trial acronym
CIICS: Cancer and Infection dissemination following Intraoperative Cell Salvage, during pelvic exenteration surgery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intraoperative cell salvage 332529 0
pelvic exenteration surgery 332698 0
colorectal cancer surgery 332699 0
Condition category
Condition code
Anaesthesiology 329221 329221 0 0
Anaesthetics
Cancer 329410 329410 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Blood 329411 329411 0 0
Other blood disorders
Surgery 329412 329412 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Blood lost from the operating field during pelvic exenteration surgery is suctioned away and usually discarded. For this study the suctioned blood will be collected into an intraoperative cell salvage (ICS) machine. It will be heparinised, and collected into a reservoir, then processed via centrifugation in the ICS machine, then filtered via a leukodepletion filter. No blood will be returned to patients in this study. This study aims to analyse blood samples collected during ICS (before processing, after processing, and after filtering) to assess if it can decrease exposure to cancer cell and bacterial when used during pelvic exenteration surgery.
Intervention code [1] 327739 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337056 0
Presence of adenocarcinoma cells in salvaged blood
Timepoint [1] 337056 0
Sampling before surgery, prior to Intraoperative Cell Salvage (ICS) processing, after ICS processing, and after ICS filtering.
Secondary outcome [1] 430503 0
Identification of bacterial contamination in salvaged blood
Timepoint [1] 430503 0
Sampling before surgery, prior to Intraoperative Cell Salvage (ICS) processing, after ICS processing, and after ICS filtering.

Eligibility
Key inclusion criteria
Patients with colorectal cancer scheduled for pelvic exenteration surgery
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who decline participation and consent.
Patients who experience <800mL blood loss during surgery.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Descriptive statistics, quantification and ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25983 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 41834 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 315682 0
Charities/Societies/Foundations
Name [1] 315682 0
Australian and New Zealand College of Anaethetists Project Grant
Country [1] 315682 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hosptial
Address
Herston, Queensland
Country
Australia
Secondary sponsor category [1] 317635 0
None
Name [1] 317635 0
Address [1] 317635 0
Country [1] 317635 0
Other collaborator category [1] 282912 0
University
Name [1] 282912 0
University of Queensland Centre for Clinical Research
Address [1] 282912 0
Herston, Queensalnd
Country [1] 282912 0
Australia
Other collaborator category [2] 282913 0
University
Name [2] 282913 0
The University of the Sunshine Coast
Address [2] 282913 0
Sippy Downs, Queensland
Country [2] 282913 0
Australia
Other collaborator category [3] 282914 0
Government body
Name [3] 282914 0
Australian Red Cross Lifeblood (ARCLB)
Address [3] 282914 0
Kelvin Grove, Queensland
Country [3] 282914 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314446 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 314446 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 314446 0
Australia
Date submitted for ethics approval [1] 314446 0
08/02/2024
Approval date [1] 314446 0
23/05/2024
Ethics approval number [1] 314446 0
HREC/2024/MNHA/104862

Summary
Brief summary
Intraoperative cell salvage (ICS) is increasingly accepted as a safe alternative to allogeneic (donated) blood transfusion (ABT) with the potential to reduce ABT related adverse outcomes and improve immune competence. Remaining obstacles include: 1) the risk of systemic bacteraemia in the presence of bacterial contamination from the surgical field and 2) the potential risk of systemic cancer cell dissemination during surgery for malignant tumours. When considering these specific obstacles (i.e., cancer and bacterial contamination risks), pelvic exenteration surgery is of particular clinical interest. These procedures aim to cure patients with locally advanced adenocarcinoma. Major blood loss, requiring massive blood transfusion, often occur. However, considering the nature of the surgical field, potentially contaminated with cancer cells and bacteria (from bowel content), ICS is not used.
The C-I-ICS study, aims to assess whether ICS (processing and filtering) could reduce the risks of cancer cell and bacterial dissemination, into the patient’s circulation, when used during curative pelvic exenteration surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131610 0
Dr Michelle Roets
Address 131610 0
Royal Brisbane and Women's Hospital, Department of Anaesthesia and Perioperative Medicine, Level 4 Ned Hanlon Building, Butterfield St, Herston, Queenland 4006
Country 131610 0
Australia
Phone 131610 0
+61 7 36467154
Fax 131610 0
Email 131610 0
[email protected]
Contact person for public queries
Name 131611 0
Michelle Roets
Address 131611 0
Royal Brisbane and Women's Hospital, Department of Anaesthesia and Perioperative Medicine, Level 4 Ned Hanlon Building, Butterfield St, Herston, Queenland 4006
Country 131611 0
Australia
Phone 131611 0
+61 7 36467154
Fax 131611 0
Email 131611 0
[email protected]
Contact person for scientific queries
Name 131612 0
Michelle Roets
Address 131612 0
Royal Brisbane and Women's Hospital, Department of Anaesthesia and Perioperative Medicine, Level 4 Ned Hanlon Building, Butterfield St, Herston, Queenland 4006
Country 131612 0
Australia
Phone 131612 0
+61 7 36467154
Fax 131612 0
Email 131612 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.