Intraoperative cell salvage vs transfusion in ovarian cancer

ISRCTN	ISRCTN19517317
DOI	https://doi.org/10.1186/ISRCTN19517317
Protocol serial number	31586
Sponsor	Royal Cornwall Hospitals NHS Trust
Funder	National Institute for Health Research

Submission date: 07/11/2016
Registration date: 11/11/2016
Last edited: 22/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-intraoperative-cell-salvage-and-blood-transfusions-for-women-having-surgery-for-ovarian-cancer

Contact information

Ms Jane Vickery
Public

Peninsula Clinical Trials Unit
N16, ITTC Building 1
Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom

Phone	+44 (0)1752 315250
Email	jane.vickery@plymouth.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Process of Care, Management of Care, Surgery
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled feasibility Trial of Intraoperative Cell salvage vs donor blood Transfusion in Ovarian Cancer surgery (TICTOC)
Study acronym	TICTOC
Study objectives	The aim of this study is to test the processes for a larger definitive trial, ascertain its feasibility and provide the necessary information to plan a full trial, assessing the clinical and cost effectiveness of intra-operative cells salvage for women undergoing surgery for ovarian cancer, compared with the usual practice of transfusing donor blood.
Ethics approval(s)	South West - Exeter Research Ethics Committee, 14/10/2016, ref: 16/SW/0256
Health condition(s) or problem(s) studied	Specialty: Cancer, Primary sub-specialty: Gynae; UKCRC code/ Disease: Cancer/ Malignant neoplasms of female genital organs
Intervention	Sixty participants will be randomised in a 1:1 ratio to intraoperative cell salvage (ICS, re-infusion of their own blood) or donor blood transfusion during surgery. Participants and outcome assessors will be blinded to the intervention. For all participants the standard operative procedure for ovarian cancer (cytoreductive surgery) will be performed. If intraoperative transfusion is required, the participant will receive either ICS or donor transfusion according to treatment allocation. Some participants may not require any intraoperative transfusion and some (either arm of the trial) may require donor blood transfusion post-operatively. Intra-operative cell salvage arm: The cell salvage system to be used in this study is the Haemonetics Cell Saver® 5+ autologous blood recovery system. All sites will follow a common ICS protocol. Collected blood will be processed using a 125ml bowl before being re-infused via a leucodepletion filter. All full bowls of salvaged blood will be reinfused back to the participant during, or at the end of, the operative procedure. ICS blood will be returned even if only small quantities are lost. Participants allocated to the ICS arm who also need donor transfusion for clinical reasons can be given donor blood at any time, during or after surgery, for the duration of their hospital stay. Donor transfusion arm: Participants allocated to donor transfusion will be considered for intraoperative transfusion in accordance with clinical judgement, guided by local hospital policy. Donor blood transfusion may also be given post-operatively in accordance with usual clinical care. Donor blood will only be given (in standard volumes) when deemed necessary (e.g. after substantial blood loss and/or drop in haemoglobin). Trial treatment is confined to the intra-operative period only. All participants will be followed up at 30 days post-operatively, by telephone, for adverse events reporting and 6 weeks and 3 months post-operatively by post. In addition, participants recruited in the early part of the study will be followed up by post at subsequent three month intervals (at 6 and 9 months) as time allows.
Intervention type	Other
Primary outcome measure(s)	Feasibility outcomes: 1. Recruitment rate is recorded as the number of eligible participants who consent to participate in the study by 12 months 2. Feasibility of randomisation immediately pre-operatively is recorded by the time interval between randomisation and beginning of surgery 3. Attrition rate is recorded as the number of participants who consent to participate that remain in the study until the end of follow up at three months 4. Completeness of proposed outcome measures will be recorded as the number of complete specific data fields within CRFs and patient questionnaire booklets received at end of follow up at three months, out of the expected total number of CRFs and booklets 5. Success of blinding of allocation for participants and outcome assessor will be recorded by the number of participants and assessors who are inadvertently made aware of their treatment allocation during the trial period 6. Success of data collection tools and methods to collect resource use data will be recorded as the proportion of completed resource use data fields available at end of follow-up 7. Acceptability of the intervention to participants will be assessed by qualitative interviews 8. Acceptability of study participation to participants will be assessed by qualitative interviews
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/06/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	60
Total final enrolment	57
Key inclusion criteria	1. 18 years old or over 2. Suspected or confirmed ovarian cancer (newly diagnosed) requiring cytoreductive surgery, whether primary or interval (following chemotherapy) 3. CT scan evidence (with or without clinical evidence) compatible with FIGO stage III/IV ovarian cancer/ primary peritoneal cancer at presentation* 4. ECOG Performance Status 0-1 5. Willing to participate and able to give written informed consent *CT features of pelvic mass (or features suggestive of primary peritoneal cancer) and extrapelvic involvement including ascites, omental disease, peritoneal thickening, bowel surface and/or mesentery involvement, enlarged pelvic and para-aortic lymph nodes, evidence of disease on diaphragm
Key exclusion criteria	1. Diagnosis of concurrent malignancy 2. Pregnant 3. Donor transfusion during the week prior to surgery 4. Haemoglobinopathies (e.g. sickle cell, thalassaemia) 5. Unwilling to accept donor blood (e.g. on religious grounds)
Date of first enrolment	17/01/2017
Date of final enrolment	28/02/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Royal Cornwall Hospital

2 Penventinnie Lane
Treliske
Truro
TR1 3LJ
United Kingdom

Derriford Hospital

Derriford Road
Plymouth
PL6 8DH
United Kingdom

Queen Elizabeth Hospital

Queen Elizabeth Avenue
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/11/2018	01/11/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			22/05/2023	No	Yes

Editorial Notes

22/05/2023: Cancer Research UK plain English results link and total final enrolment added.
01/11/2019: Publication reference added.
19/04/2018: The recruitment start date was changed from 01/11/2016 to 17/01/2017.
12/02/2018: The recruitment end date was changed from 31/01/2018 to 28/02/2018.
02/11/2017: The recruitment end date was changed from 31/10/2017 to 31/01/2018.
06/06/2017: Cancer Help UK lay summary link added to plain English summary field