A national perioperative platform trial to improve outcomes for surgical patients (PROTECT)
| ISRCTN | ISRCTN14639555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14639555 |
| IRAS number | 353122 |
- Submission date
- 20/06/2025
- Registration date
- 23/06/2025
- Last edited
- 23/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Clinical implementation of new treatments requires evidence from clinical trials. Traditional clinical trials compare two groups: a treatment group and a control group. However, traditional trials are time-consuming and expensive, often taking a long time to set-up, open new centres and start enrolling patients. This delays implementation of new treatments. Platform trials offer a new approach that was used very successfully during the pandemic. Instead of comparing one treatment group to one control group, platform trials compare multiple treatment groups to one control group. Once established, platforms continue to run, with new treatments added as they become available. This reduces the overall number of patients required and reduces the time and cost of setting up a new trial, which makes platform trials a very efficient way to test new treatments. Our aim is to establish a national platform trial for surgical patients is urgently needed.
Who can participate?
Patients aged 18 years and over being treated in an NHS surgical care pathway.
What does the study involve?
This is a trial designed to test multiple research questions for patients undergoing surgery, or within a surgical care pathway. Patient eligibility will be evaluated separately for each research question and they will be offered the opportunity to take part in any or all of the studies for which they are eligible.
For participants who enrol in the Protect platform only, a common outcome dataset will be collected at 30 days and 90 days after surgery about their health and well-being. In addition, longer-term outcomes may be collected using national NHS databases including Hospital Episode Statistics or the equivalent databases in Wales, Scotland and Northern Ireland, and Civil Registration Data.
What are the possible benefits and risks of participating?
Participants may not benefit directly from taking part in this study. By taking part in studies looking at new ways to improve the care they will receive and by allowing the research team to collect information about their healthcare, we hope to improve the health outcomes for surgical patients in the future.
Where is the study run from?
Surgical services of NHS hospitals (UK)
When is the study starting and how long is it expected to run for?
January 2025 to December 2034
Who is funding the study?
1. Barts Charity (G-002514)
2. Academy of Medical Science (SGL029\1104)
3. British Journal of Anaesthesia (WKR0-2023-0016)
Who is the main contact?
1. Priyanthi Dias (p.dias@qmul.ac.uk)
2. Salma Begum (salma2.begum@qmul.ac.uk)
Contact information
Public
ACCU Research Offices
4th Floor, Office 14
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom
 ORCID ID |
0000-0003-1740-6165 |
|---|---|
| Phone | +44 20 3594 0349 |
| p.dias@qmul.ac.uk |
Scientific, Principal Investigator
ACCU Research Offices
4th Floor, Office 14
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom
| ORCID ID |
0000-0002-8664-3001 |
|---|---|
| Phone | +44 20 3594 0349 |
| t.abbott@qmul.ac.uk |
Study information
| Study design | This is a multi-centre multi-factorial platform trial designed to test multiple comparisons (research questions) for patients undergoing surgery, or within a surgical care pathway. Patient eligibility will be evaluated for the platform (master protocol) and for each comparison (protocol appendix). Patients enrolled in the PROTECT platform will be offered the opportunity to take part in any and/or all of the comparisons for which they are eligible. Patients can be enrolled in the platform (master protocol) only or the platform (master protocol) plus one or more comparison(s). Comparisons may be contemporaneous or distributed throughout the surgical care pathway. As new comparisons are added to the platform, they will be assigned a comparison-specific acronym suffix (e.g. PROTECT-AEGIS, etc.), and the comparison-specific trial methodology and delivery will be described in separate appendices to this master protocol document. Each comparison will be added as an individual submission to the relevant regulatory authorities. Amendments made to the master protocol will apply to all appendices. Amendments to an appendix describing an individual comparison(s) will only be relevant to that appendix. The PROTECT master protocol is the over-arching protocol which describes the common trial design, delivery and data sets, as well as trial governance procedures common to all comparisons within the platform. Where additional procedures are required, specific to a comparison, for example the collection of additional safety data, these will be described in the appendix for that comparison. The individual appendices are not co-dependent and each will have a separate start and end date. Appendices to the PROTECT master protocol will be added and/or removed throughout the course of the programme. Analyses will be conducted on locked comparison specific datasets and published without compromising the integrity of ongoing platform comparisons. Each individual comparison will have a lead investigator listed in the comparison appendix. Participants enrolled into PROTECT will fall into one or more of the below study categories depending on the eligibility criteria and the journey of their care pathway: • PROTECT platform • Non-interventional (non-randomised) studies • Interventional studies that do not involve Investigational Medicinal Products (IMPs) • Interventional studies that involve an IMP |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Platform trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A national perioperative platform trial to improve outcomes for surgical patients (PROTECT) |
| Study acronym | PROTECT |
| Study objectives | To establish a research and governance infrastructure for the efficient delivery of a suite of surgical and/or perioperative care comparisons to improve outcomes for patients undergoing surgery. |
| Ethics approval(s) |
Approved 03/02/2025, London - South East Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 207 104 8222; londonsoutheast.rec@hra.nhs.uk), ref: 25/LO/0043 |
| Health condition(s) or problem(s) studied | All adult patients (≥18 years) being treated within a surgical care pathway at the recruitment sites will be eligible for the trial. |
| Intervention | A common outcome dataset will be collected for all patients at 30 days and 90 days after surgery. In addition, longer-term outcomes may be collected using routinely collected data (for example Hospital Episode Statistics (HES) and Civil Registration data) up until the last follow up time-point for the participant according to the nature of the groups in which they are enrolled in. Where applicable, primary and secondary outcomes will be described in full in the relevant appendix. Additionally, for CTIMPs, depending on the risk and status of the investigations, part of the objectives will be to collect safety endpoints. |
| Intervention type | Other |
| Primary outcome measure | Measured using patient records: 1. Complications within 30 days after surgery 2. Days alive and at home at 30 and 90 days after surgery 3. Mortality at 30 and 90 days and one year after surgery 4. Health-related quality of Life (EQ-5D-5L) at 30 and 90 days after surgery 5. Duration of primary hospital admission up to 90 days after surgery 6. Re-admission to hospital within 90 days of surgery |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2025 |
| Completion date | 01/01/2035 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 932 |
| Key inclusion criteria | All adult patients (≥18 years) being treated within a surgical care pathway at the recruitment sites will be eligible for the trial. |
| Key exclusion criteria | Inability or refusal to provide informed consent. |
| Date of first enrolment | 01/01/2025 |
| Date of final enrolment | 01/01/2035 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
80 Newark Street
London
E1 2ES
United Kingdom
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
London
SW3 6JJ
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
530 London Road
Thornton Heath
CR7 7YE
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Clydebank
G81 4DY
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Sponsor information
University/education
Joint Research Management Office
Dept W, 69-89 Mile End Road
London
E1 4UJ
England
United Kingdom
| Phone | +44 20 7882 7275/6574 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | https://www.jrmo.org.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- British Journal of Anaesthesia Ltd, BJA
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Academy of Medical Sciences
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Data arising from this research will be made available to the scientific community in a timely and responsible manner. Detailed scientific reports will be submitted to a widely accessible scientific journal on behalf of the PROTECT Group. The PSC will agree the membership of a writing committee, which will take primary responsibility for final data analysis and writing of the scientific report(s). All members of the writing committee will comply with internationally agreed requirements for authorship and will approve the final manuscript prior to submission. The full study report will be accessible via ISRCTN or other suitable public registry within one year of the End of the Trial Notification. Please see PROTECT publication charter for further details. |
| IPD sharing plan | Available on request. Data sharing statement to be made available at a later date. |
Editorial Notes
20/06/2025: Trial's existence confirmed by Barts Charity
