Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/08/2019
Date assigned
10/09/2019
Last edited
10/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Katy Mironov

ORCID ID

Contact details

Oxford Trauma Kadoorie Centre Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 227226
White9@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 42503

Study information

Scientific title

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

Acronym

WHiTE 9

Study hypothesis

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.

Ethics approval

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

Study design

Randomised; Interventional; Design type: Treatment, 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

Fracture of neck of femur

Intervention

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

Phase

Drug names

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

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 trial start date

01/04/2019

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 96; UK Sample Size: 96

Participant 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)

Recruitment start date

01/10/2019

Recruitment end date

31/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Walsgrave General Hospital
University Hospitals Coventry & Warwickshire NHS Trust Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Luton and Dunstable University Hospital NHS Foundation Trust
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Trial participating centre

Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
Royal Berkshire Hospital London Road
Reading
RG15AN
United Kingdom

Trial participating centre

Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS Trust

Sponsor details

Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+442476 965031
R&DSponsorship@uhcw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0817-20037

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/10/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/08/2019: Trial's existence confirmed by the NIHR.