Condition category
Cancer
Date applied
07/11/2016
Date assigned
11/11/2016
Last edited
02/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Ms Jane Vickery

ORCID ID

Contact details

Peninsula Clinical Trials Unit
N16
ITTC Building 1
Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom
+44 (0)1752 315250
jane.vickery@plymouth.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31586

Study information

Scientific title

A randomised controlled feasibility Trial of Intraoperative Cell salvage vs donor blood Transfusion in Ovarian Cancer surgery (TICTOC)

Acronym

TICTOC

Study hypothesis

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

South West - Exeter Research Ethics Committee, 14/10/2016, ref: 16/SW/0256

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Management of Care, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2016

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant 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)

Recruitment start date

01/11/2016

Recruitment end date

31/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Cornwall Hospital
2 Penventinnie Lane Treliske
Truro
TR1 3LJ
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Queen Elizabeth Avenue Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Organisation

Royal Cornwall Hospitals NHS Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The 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 plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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