Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial

Conditions
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Hip Fracture

Intervention / Treatment
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* Biological: Blood transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of hip fracture Surgery treatment Living in nursing homes or sheltered housing facilities Haemoglobin level between 6 and 7 mmol/l latest 6th day after surgery Written consent Exclusion Criteria: Active cancer Pathological fracture The patient is against blood transfusion

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood transfusion<br>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<br>* An expanded indication for blood transfusion in the frail elderly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ability | Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI) | Measured 10 days after surgery + repeated measurement during 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Measurement by the Danish Central Office of Civil Registration | Measured 30 and 90 days after surgery | 
| Quality of Life | Measurement by Depression List (DL) | Measured 30 days and 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood transfusion, Hip fracture, Elderly, Geriatrics, Hospitalization, Frail elderly