Clinical trial NCT01102010: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture
Official title: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hip Fracture
Keywords: Blood transfusion
Hip fracture
Elderly
Geriatrics
Hospitalization
Frail elderly
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 284
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional ability
timeFrame: Measured 10 days after surgery + repeated measurement during 90 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: Measured 30 and 90 days after surgery
measure: Quality of Life
timeFrame: Measured 30 days and 1 year after surgery
Other outcomes:
measure: Delirium
timeFrame: Percentage of participants with delirium measured 10 days after surgery by the score 'Confusion Assessment Method'
Locations:
city: Aarhus
country: Denmark
facility: Research Unit, Geriatric Department, Aarhus University Hospital
state: Central Denmark Region
Study officials:
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.