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A multi centre randomised controlled trial comparing intra operative cell salvage with standard care in the treatment of hip fractures

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15945622
Enrollment
1128
Registered
2019-09-10
Start date
2019-10-01
Completion date
Unknown
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of neck of femur Injury, Occupational Diseases, Poisoning Fracture of neck of femur

Interventions

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 potentiall

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026