Postoperative Blood Transfusion for Frail Elderly With Hip Fracture
Primary Purpose
Hip Fracture
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Blood transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring Blood transfusion, Hip fracture, Elderly, Geriatrics, Hospitalization, Frail elderly
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
Sites / Locations
- Research Unit, Geriatric Department, Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood transfusion
Arm Description
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)
Outcomes
Primary Outcome Measures
Functional ability
Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)
Secondary Outcome Measures
Mortality
Measurement by the Danish Central Office of Civil Registration
Quality of Life
Measurement by Depression List (DL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01102010
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Blood transfusion, Hip fracture, Elderly, Geriatrics, Hospitalization, Frail elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood transfusion
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Blood transfusion
Intervention Description
An expanded indication for blood transfusion in the frail elderly
Primary Outcome Measure Information:
Title
Functional ability
Description
Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)
Time Frame
Measured 10 days after surgery + repeated measurement during 90 days after surgery
Secondary Outcome Measure Information:
Title
Mortality
Description
Measurement by the Danish Central Office of Civil Registration
Time Frame
Measured 30 and 90 days after surgery
Title
Quality of Life
Description
Measurement by Depression List (DL)
Time Frame
Measured 30 days and 1 year after surgery
Other Pre-specified Outcome Measures:
Title
Delirium
Description
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.
Time Frame
Percentage of participants with delirium measured 10 days after surgery by the score 'Confusion Assessment Method'
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Unit, Geriatric Department, Aarhus University Hospital
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34932836
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.
Results Reference
derived
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Postoperative Blood Transfusion for Frail Elderly With Hip Fracture
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