Postoperative Blood Transfusion for Frail Elderly With Hip Fracture
Elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. Acute anaemia is worse tolerated in elderly, than in younger patients. Therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial|
- Functional ability [ Time Frame: Measured 10 days after surgery + repeated measurement during 90 days after surgery ] [ Designated as safety issue: No ]Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)
- Mortality [ Time Frame: Measured 30 and 90 days after surgery ] [ Designated as safety issue: No ]Measurement by the Danish Central Office of Civil Registration
- Quality of Life [ Time Frame: Measured 30 days and 1 year after surgery ] [ Designated as safety issue: No ]Measurement by Depression List (DL)
- Delirium [ Time Frame: Percentage of participants with delirium measured 10 days after surgery by the score 'Confusion Assessment Method' ] [ Designated as safety issue: No ]It is an ancillary study to the trial to examine delirium as an outcome in a subsample of 179 nursing home residents. Furthermore, we evaluate if delirium is associated with mortality.
|Study Start Date:||January 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Blood transfusion
Restrictive strategy: Blood transfusion when hemoglobin is less than 6 mmol/l (9.7 g/dl)
Liberal strategy: Blood transfusion when hemoglobin is less than 7 mmol/l (11.3 g/dl)
Biological: Blood transfusion
An expanded indication for blood transfusion in the frail elderly
All elderly patients aged 65 and above who are hospitalised from nursing home or sheltered housing facilities to the Orthopaedic Surgery Ward at Aarhus University Hospital with hip fracture and treated operatively, are eligible for this study. According to sample size calculations 284 patients are needed. Informed consent or deputy informed consent, if the patient is cognitively impaired, is needed. Inclusion is dependent on a haemoglobin measure between 6 and 7 mmol/l 6 days after surgery at the latest. Randomization will be computerised. Randomization will determine intervention with blood transfusion and the measurement of haemoglobin is blinded to the patient, relatives, and endpoint assessor. Both transfusion groups will receive blood when haemoglobin is less than 6 mmol/l, as recommended by the Danish Health and Medicine Authority. Geriatric and Orthopaedic Team (GO-team), consisting of following trained specialists: physiotherapist, nurse, and physician, will conduct medical evaluations, including blood transfusions, from admission until 30 days after surgery. The GO-team will work on weekdays both at the Orthopaedic surgery ward and in the patients home immediately after discharge. In accordance with Aarhus Blood Bank's instructions, blood transfusions are given both under hospitalisation, in the nursing homes and in the sheltered housings. Outcomes are functional ability and mortality during 90 days, and overall quality of life (OQoL) after 30 days and 1 year. The association between physical recovery and OQoL are tested.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102010
|Research Unit, Geriatric Department, Aarhus University Hospital|
|Aarhus, Central Denmark Region, Denmark, 8000|