A multi centre randomised controlled trial comparing intra operative cell salvage with standard care in the treatment of hip fractures
| ISRCTN | ISRCTN15945622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15945622 |
| Secondary identifying numbers | CPMS 42503 |
- Submission date
- 27/08/2019
- Registration date
- 10/09/2019
- Last edited
- 09/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Current plain English summary as of 08/04/2020:
Background and study aims
Patients admitted with a hip fracture are typically elderly, frail and have multiple medical co-morbidities, including low red bold cell count (anaemia). As a consequence of the fracture and urgent surgery, patients sustain blood loss, worsening this pre-existing anaemia. In patients with a fractured hip allogenic (blood from a donor) blood transfusion is required in up to 30% of patients. Blood transfusions impose some risks to patients, such as an increased rate of infection. Allogenic blood use is associated with transfusion reactions and an increased length of hospital stay. Concerns regarding patient safety and the costs of allogenic blood have driven efforts to reduce transfusion rates. ‘Intraoperative cell salvage and autotransfusion’ is a method of collecting blood lost during surgery and transfusing it back to the patient. The cell salvage device separates oxygen-carrying red blood cells lost during surgery, prior to transfusing them back to the patient. Complications as a result of cell salvage are rare. Despite not currently being used routinely, there are large potential benefits of using cell salvage during hip fracture surgery. The study aim is to evaluate the clinical effectiveness of cell salvage in hip fracture surgery.
Who can participate?
Participants of 60 years of age and older who have sustained a fracture of the hip who, in the
opinion of the operating surgeon, would benefit from surgery
What does the study involve?
The study will include a comparison between ‘cell salvage’ with ‘treatment as usual’ to the blood lost during hip surgery. Treatment as usual involves a standard suction system removing blood lost in the operation and disposed of in clinical waste. In either treatment arm patients may receive donor’s blood transfusion before the operation. Then need for allogenic blood products will be determined on an individual patient basis, following each centres blood transfusion policy.
What are the possible benefits and risks of participating?
Any operation for a broken hip carries some risks. The risk of surgery with an implant include: bleeding requiring blood transfusion, infection, further fracture, dislocation, leg length discrepancy, blood clots, damage to nerves and blood vessels in the surgical care, and the risks associated with the anaesthetic. Allogenic blood transfusion carries the risk of increased rate of local and systematic infections. These risks are the same as for patients who are not part of this research project. Cell salvage is very safe as patients own blood is used. There is no specific advantage for participant taking part in the trials. However, the information we get from this trial will inform the future practice and will benefit future patients.
Where is the study run from?
John Radcliffe Hospital, Oxford, UK
When is the study starting and how long is it expected to run for?
October 2019 to March 2023
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
Katy Mironov
White9@ndorms.ox.ac.uk
_____
Previous plain English summary:
Background and study aims
Patients admitted with a hip fracture are typically elderly, frail and have multiple medical co-morbidities, including low red bold cell count (anaemia). As a consequence of the fracture and urgent surgery, patients sustain blood loss, worsening this pre-existing anaemia. In patients with a fractured hip allogenic (blood from a donor) blood transfusion is required in up to 30% of patients. Blood transfusions impose some risks to patients, such as an increased rate of infection. Allogenic blood use is associated with transfusion reactions and an increased length of hospital stay. Concerns regarding patient safety and the costs of allogenic blood have driven efforts to reduce transfusion rates. ‘Intraoperative cell salvage and autotransfusion’ is a method of collecting blood lost during surgery and transfusing it back to the patient. The cell salvage device separates oxygen-carrying red blood cells lost during surgery, prior to transfusing them back to the patient. Complications as a result of cell salvage are rare. Despite not currently being used routinely, there are large potential benefits of using cell salvage during hip fracture surgery.
The study aim is to evaluate the clinical effectiveness of cell salvage in hip fracture surgery. Prior to assessing this in a full-size clinical trial we need to understand if surgeons and patients are willing to participate in such a study and if sufficient blood is lost during surgery to make cell salvage viable. Therefore this is a feasibility study to determine if a full study is possible and worthwhile.
Who can participate?
Participants of 60 years of age and older who have sustained a fracture of the hip who, in the opinion of the operating surgeon, would benefit from surgery
What does the study involve?
The study will include a comparison between ‘cell salvage and autotransfusion’ with ‘treatment as usual’ to the blood lost during hip surgery. Treatment as usual involves a standard suction system removing blood lost in the operation and disposed of in clinical waste. In either treatment arm patients may receive donor’s blood transfusion before the operation. Then need for allogenic blood products will be determined on an individual patient basis, following each centres blood transfusion policy.
What are the possible benefits and risks of participating?
Any operation for a broken hip carries some risks. The risk of surgery with an implant include: bleeding requiring blood transfusion, infection, further fracture, dislocation, leg length discrepancy, blood clots, damage to nerves and blood vessels in the surgical care, and the risks associated with the anaesthetic. Allogenic blood transfusion carries the risk of increased rate of local and systematic infections. These risks are the same as for patients who are not part of this research project. Cell salvage is very safe as patients own blood is used. There is no specific advantage for participant taking part in the trials. However, the information we get from this trial will inform the future practice and will benefit future patients.
Where is the study run from?
John Radcliffe Hospital, Oxford, UK
When is the study starting and how long is it expected to run for?
October 2019 to September 2020
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
Katy Mironov
White9@ndorms.ox.ac.uk
Contact information
Scientific
Oxford Trauma Kadoorie Centre Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 227226 |
|---|---|
| White9@ndorms.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The World Hip Trauma Evaluation Nine (WHiTE 9) BeST: A multi-centre randomised controlled trial comparing intraoperative cell salvage with standard care in the treatment of hip fractures |
| Study acronym | WHiTE 9 |
| Study objectives | The aim of the main study is to determine the clinical and cost-effectiveness of intraoperative cell salvage, compared to standard care, in improving health-related quality-of-life in patients undergoing hip fracture surgery. |
| Ethics approval(s) | 1. Approved 14/08/2019, Wales Research Ethics Committee 5 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; +447970422139; Wales.REC5@wales.nhs.uk), ref: 19/WA/0197 2. Amendment 02 for the main study approved by Wales Research Ethics Committee 5 on 03/04/2020 (details as above) |
| Health condition(s) or problem(s) studied | Fracture of neck of femur |
| Intervention | Current interventions as of 08/04/2020: Patients over 60 years of age, both those with and without capacity, who sustain a hip fracture and are treated operatively, will be potentially eligible to be randomised to either undergo cell salvage or they will follow the standard care pathway- a standard suction system removes blood lost in the operating field and it is disposed of in the clinical waste. In either treatment arm, patients may receive donor's (allogenic) blood transfusion before the operation. The need for allogenic blood products will be determined on an individual patient basis, following each centre's blood transfusion policy. Patients who are younger than 60, treated non-operatively or undergoing cannulated hip screw fixation will not be eligible. Patients for whom the treating surgeon has already elected to use cell salvage (for example Jehovah Witness) or those who have sustained a pathological fracture will also be excluded. Participants will undergo surgery at the next available opportunity on a planned trauma list. Participants will be blinded to the treatment allocation. The operating surgeon cannot be blinded to the allocation but they will not be involved in the assessment of outcomes. Participants will be kept blinded until the completion of the trial when the blinding will be broken if requested by the patients. There will be no formal analysis of the success of the blinding. Following hip surgery, all patients will undergo a routine rehabilitation prior to discharge from the hospital. Research staff will complete the data regarding the operation received and autotransfusion blood volume will be recorded at baseline. In addition, the following data will be collected: - Demographic and baseline characteristics (e.g. age, gender, pre-fracture mobility) - Pre-injury quality of life (EQ5D) and at 4 and 12 months postoperatively - Routine 'operation notes', perioperative complications, and discharge details - The volume of blood that was autotransfused, when this was possible - The number of donor blood units transfused and the date of transfusion will be collected - Haemoglobin concentration - Pre and postoperative delirium assessment - Details of admission, assessment and treatment - Contact details, including of carers when appropriate - Complications and SAEs during the study period Following their 12 months questionnaire, patients will have completed their participation in the trial and will continue to be treated as per normal standard of care. _____ Previous interventions: This will be a multi-centre feasibility randomised controlled trial. The study will include a comparison between a cell salvage and autotransfusion with the standard of care approach to the blood lost during hip surgery. The study will be linked to the established WHiTE Comprehensive Cohort Study. Patients over 60 years of age, both those with and without capacity, who sustain a hip fracture and are treated operatively, will be potentially eligible to be randomised to either undergo cell salvage and autotransfusion or they will follow the standard care pathway- a standard suction system removes blood lost in the operating field and it is disposed of in clinical waste. In either treatment arm, patients may receive donor's (allogenic) blood transfusion before the operation. The need for allogenic blood products will be determined on an individual patient basis, following each centre's blood transfusion policy. Patients who are younger than 60, treated non-operatively or undergoing cannulated hip screw fixation will not be eligible. Patients for whom the treating surgeon has already elected to use cell salvage (for example Jehovah Witness) or those who have sustained a pathological fracture will also be excluded. Participants will undergo surgery at the next available opportunity on a planned trauma list. Participants will be blinded to the treatment allocation. The operating surgeon cannot be blinded to the allocation but they will not be involved in the assessment of outcomes. Participants will be kept blinded until the completion of the trial when the blinding will be broken if requested by the patients. There will be no formal analysis of the success of the blinding. Following hip surgery, all patients will undergo a routine rehabilitation prior to discharge from the hospital. Research staff will complete the data regarding the operation received and autotransfusion blood volume will be recorded at baseline. In addition, the following data will be collected: - Demographic and baseline characteristics (e.g. age, gender, pre-fracture mobility) Pre-injury quality of life (EQ5D) and at 30 and 120 days postoperatively - Routine 'operation notes', perioperative complications, and discharge details - The volume of blood that was autotransfused, when this was possible - The number of donor blood units transfused and the date of transfusion will be collected - Haemoglobin concentration - Pre and postoperative delirium assessment - Details of admission, assessment and treatment - Contact details, including of carers when appropriate - Complications and SAEs during the study period Following their 120-day questionnaire, patients will have completed their participation in the trial and will continue to be treated as per normal standard of care. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 08/04/2020: Health-related quality of life measured using the EuroQol 5 dimension(EQ-5D-5L) score at baseline (retrospective pre-fracture status) and 4 months post-operatively _____ Previous primary outcome measure: 1. Recruitment rate per centre 2. The number of patients for whom autotransfusion is possible 3. The volume of blood autotransfused |
| Secondary outcome measures | Current secondary outcome measures as of 08/04/2020: 1. Health-related quality of life measured using the EuroQol 5 dimension(EQ-5D-5L) score at baseline and 12 months post-operatively 2. Post-operative delirium risk measured using 4AT at baseline 3. Residential status measured using NHFD questions at 4 and 12 months post-surgery 4. Mobility measured using NHFD questions at 4 and 12 months post-surgery 5. Allogenic blood usage measured using hospital records at baseline 6. Mortality measured using death notifications from hospital records at 4 and 12 months post-operatively 7. Haemoglobin concentration at baseline 8. Complications, measured using medical records (check any complication classified as adverse events on the protocol will be collected from recruitment until the 12 -month time point) 9. Costs and comparative cost-effectiveness measured using hospital records and resource use questionnaire at 4 and 12 months post-operatively _____ Previous secondary outcome measures: 1. Health-related Quality of life will be collected using the EuroQol 5 dimension(EQ-5D-5L) score. This will be collected at baseline(retrospective pre-fracture status), 30 and 120 days post-operatively. 2. Units of allogenic blood transfused, this information will be collected at baseline. 3. Mortality 4. Haemoglobin concentration, this information will be collected at baseline 5. Complications, any complication classified as adverse events on the protocol will be collected from recruitment until the 4-month time point. 5. Resource use, costs and comparative cost-effectiveness |
| Overall study start date | 01/04/2019 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1,128; UK Sample Size: 1,128 |
| Key inclusion criteria | Participants of 60 years of age and older who have sustained a fracture of the hip who, in the opinion of the operating surgeon, would benefit from surgery |
| Key exclusion criteria | 1. Patients younger than 60 years of age 2. Patients undergoing percutaneous hip screw fixation 3. Patients who have sustained a pathological fracture 4. Patients for whom the treating surgeon has already elected to use cell salvage (for example Jehovah Witness) |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Oxford
OX3 9DU
United Kingdom
London Road
Reading
RG15AN
United Kingdom
Windmill Road
Gillingham
ME7 5NY
United Kingdom
London
SW17 0QT
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
London
E11 1NR
United Kingdom
North Shields
NE29 8NH
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Bristol
BS10 5NB
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Derby
DE22 3NE
United Kingdom
Durham County
Durham
DH1 5TW
United Kingdom
Llanfrechfa
Cwmbran
NP44 8YN
United Kingdom
Sponsor information
Hospital/treatment centre
Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| Phone | +44 (0)2476 965031 |
|---|---|
| R&DSponsorship@uhcw.nhs.uk | |
"ROR" |
https://ror.org/025n38288 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Reasonable requests for access to the datasets can be made to Prof Xavier Griffin (X.griffin@qmul.ac.uk), three years after the publication of the clinical results of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/06/2022 | 09/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/06/2022: Publication reference added.
01/04/2022: The recruitment end date has been changed from 01/01/2023 to 30/11/2021.
25/03/2022: IPD sharing statement added.
03/09/2021: The recruitment end date was changed from 30/09/2021 to 01/01/2023.
11/08/2021: The trial participating centres were updated to remove Warwick Hospital and add Pinderfields Hospital, University Hospital of Wales, Southmead Hospital, Doncaster Royal Infirmary, Royal Derby Hospital, University Hospital Of North Durham, and The Grange University Hospital.
25/06/2021: The acronym has been changed from WHiTE 9 BeST to WHiTE 9
09/12/2020: The following changes were made to the trial record:
1. The trial website was added.
2. The trial participating centre Walsgrave General Hospital was changed to University Hospital Coventry
3. The trial participating centre North Tyneside General Hospital was added.
26/11/2020: The following changes were made to the trial record:
1. The trial participating centres Worcestershire Royal Hospital and Luton and Dunstable University Hospital NHS Foundation Trust were removed.
2. The trial participating centres Medway Maritime Hospital, St George’s Hospital, London, Royal Derby Hospital, Queens Medical Centre, Nottingham, and Whipps Cross Hospital, London were added.
03/08/2020: The recruitment resumed.
15/04/2020: Internal review.
08/04/2020: The following changes were made to the trial record after the feasibility study was stopped and converted to a full trial:
1. The public title was changed from "Is it feasible to conduct a definitive multi-centre randomised controlled trial of intraoperative cell salvage and autotransfusion compared to standard care in patients undergoing hip fracture surgery?" to "A multi centre randomised controlled trial comparing intra operative cell salvage with standard care in the treatment of hip fractures".
2. The scientific title was changed from "The World Hip Trauma Evaluation Nine (WHiTE 9): A feasibility randomised controlled trial comparing intraoperative washed cell salvage and autotransfusion with standard care for the treatment of hip fractures" to "The World Hip Trauma Evaluation Nine (WHiTE 9) BeST: A multi-centre randomised controlled trial comparing intraoperative cell salvage with standard care in the treatment of hip fractures".
3. The acronym was changed from WHiTE 9 to WHiTE 9 BeST.
4. The study hypothesis was changed from "The researchers propose evaluating the clinical effectiveness of cell salvage in hip fracture surgery. Prior to assessing this in a definitive clinical trial they need to understand if surgeons and patients are willing to participate in such a study, and if sufficient blood is lost during surgery to make cell salvage viable." to "The aim of the main study is to determine the clinical and cost-effectiveness of intraoperative cell salvage, compared to standard care, in improving health-related quality-of-life in patients undergoing hip fracture surgery".
5. The overall end date was changed from 30/09/2020 to 31/03/2023.
6. The interventions were changed.
7. The primary outcome measure was changed.
8. The secondary outcome measures were changed.
9. The target number of participants was changed from 96 to 1,128.
10. The recruitment end date was changed from 31/03/2020 to 30/09/2021.
11. The intention to publish date was changed from 31/10/2021 to 31/03/2023.
12. The plain English summary was updated to reflect these changes.
03/04/2020: Due to current public health guidance, recruitment for this study has been paused.
27/08/2019: Trial's existence confirmed by the NIHR.
