Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102010
• Other study ID #: PBTFEHF
• Status: Completed
• Phase: Phase 0
• First received: April 8, 2010
• Last updated: July 16, 2015
• Start date: January 2010
• Est. completion date: October 2014

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Data Protection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Biological:
• Blood transfusion
An expanded indication for blood transfusion in the frail elderly

Locations

Country	Name	City	State
Denmark	Research Unit, Geriatric Department, Aarhus University Hospital	Aarhus	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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'	No
Primary	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	No
Secondary	Mortality	Measurement by the Danish Central Office of Civil Registration	Measured 30 and 90 days after surgery	No
Secondary	Quality of Life	Measurement by Depression List (DL)	Measured 30 days and 1 year after surgery	No