Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Biological: Blood transfusion

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.

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, 8000
      • Research Unit, Geriatric Department, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional ability	Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)	Measured 10 days after surgery + repeated measurement during 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Measurement by the Danish Central Office of Civil Registration	Measured 30 and 90 days after surgery
Quality of Life	Measurement by Depression List (DL)	Measured 30 days and 1 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	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.	Percentage of participants with delirium measured 10 days after surgery by the score 'Confusion Assessment Method'

Collaborators and Investigators

• Sponsor: University of Aarhus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Elderly; Geriatrics; Hospitalization; Hip fracture; Blood transfusion; Frail elderly
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PBTFEHF