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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
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 autotransfusi CONDITION: Fracture of neck of femur ; Injury, Occupational Diseases, Poisoning ; Fracture of neck of femur PRIMARY OUTCOME: ; 1. Recruitment rate per centre; 2. The number of patients for whom autotransfusion is possible; 3. The volume of blood autotransfused; SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 30616b7bc020a56d5d0450ad879d65fe6ec9dec7
First added on: Aug 24, 2024