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Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102010
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : July 20, 2015
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Biological: Blood transfusion Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial
Study Start Date : January 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102010

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Research Unit, Geriatric Department, Aarhus University Hospital
Aarhus, Central Denmark Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus

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Responsible Party: University of Aarhus Identifier: NCT01102010     History of Changes
Other Study ID Numbers: PBTFEHF
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: August 2013
Keywords provided by University of Aarhus:
Blood transfusion
Hip fracture
Frail elderly
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries