Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

Early Phase 1

Completed

• Conditions: Hip Fracture
• Interventions: Biological: Blood transfusion

• Registration Number: NCT01102010
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-09
• Study First Posted: 2010-04-12
• Status Verified: 2013-08
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood transfusion	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)

Primary Outcome Measures

Name	Time	Method
Functional ability	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

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

Trial Locations

Locations (1)

Research Unit, Geriatric Department, Aarhus University Hospital; 🇩🇰 Aarhus, Central Denmark Region, Denmark