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Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01102010
First received: April 8, 2010
Last updated: November 17, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Hip Fracture
Biological: Blood transfusion
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Functional ability [ Time Frame: Measured 10 days after surgery + repeated measurement during 90 days after surgery ] [ Designated as safety issue: No ]
    Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)


Secondary Outcome Measures:
  • Mortality [ Time Frame: Measured 30 and 90 days after surgery ] [ Designated as safety issue: No ]
    Measurement by the Danish Central Office of Civil Registration

  • Quality of Life [ Time Frame: Measured 30 days and 1 year after surgery ] [ Designated as safety issue: No ]
    Measurement by Depression List (DL)


Enrollment: 284
Study Start Date: January 2010
Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102010

Locations
Denmark
Research Unit, Geriatric Department, Aarhus University Hospital
Aarhus, Central Denmark Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01102010     History of Changes
Other Study ID Numbers: PBTFEHF
Study First Received: April 8, 2010
Last Updated: November 17, 2014
Health Authority: Denmark: Danish Data Protection Agency

Keywords provided by University of Aarhus:
Blood transfusion
Hip fracture
Elderly
Geriatrics
Hospitalization
Frail elderly

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014