Intraoperative cell salvage vs transfusion in ovarian cancer

ISRCTN ISRCTN19517317
DOI https://doi.org/10.1186/ISRCTN19517317
Secondary identifying numbers 31586
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

Study designRandomised; Interventional; Design type: Treatment, Process of Care, Management of Care, Surgery
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA randomised controlled feasibility Trial of Intraoperative Cell salvage vs donor blood Transfusion in Ovarian Cancer surgery (TICTOC)
Study acronymTICTOC
Study objectivesThe 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) studiedSpecialty: Cancer, Primary sub-specialty: Gynae; UKCRC code/ Disease: Cancer/ Malignant neoplasms of female genital organs
InterventionSixty 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 typeOther
Primary outcome measureFeasibility 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
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/07/2016
Completion date30/06/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned Sample Size: 60; UK Sample Size: 60
Total final enrolment57
Key inclusion criteria1. 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 criteria1. 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 enrolment17/01/2017
Date of final enrolment28/02/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

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

Sponsor information

Royal Cornwall Hospitals NHS Trust
Hospital/treatment centre

Research, Development & Innovation Manager
Knowledge Spa
Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
England
United Kingdom

ROR logo "ROR" https://ror.org/026xdcm93

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe study team will prepare a plain English summary of the study results which will be made available to study participants as soon as possible after the end of the study (June 2018). The final results of the study will be disseminated via presentations at appropriate scientific meetings and conferences and publication in appropriate peer-reviewed journals. Indicative publication date end 2018.
IPD sharing planThe 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
Plain English results 22/05/2023 No Yes
HRA research summary 28/06/2023 No No

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