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Completed

NCT Number: NCT01102010

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Unit, Geriatric Department, Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood transfusion

Biological

An expanded indication for blood transfusion in the frail elderly

Primary outcomes

  1. Functional ability

    Time frame: Measured 10 days after surgery + repeated measurement during 90 days after surgery

    Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)

Secondary outcomes

  1. Mortality

    Time frame: Measured 30 and 90 days after surgery

    Measurement by the Danish Central Office of Civil Registration

  2. Quality of Life

    Time frame: Measured 30 days and 1 year after surgery

    Measurement by Depression List (DL)

Other outcomes

  1. Delirium

    Time frame: Percentage of participants with delirium measured 10 days after surgery by the score 'Confusion Assessment Method'

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Apr 12, 2010
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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