search
Back to results

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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

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

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 8, 2010
Last Updated
July 16, 2015
Sponsor
University of Aarhus
search

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

Learn more about this trial

Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

We'll reach out to this number within 24 hrs