Text Size

Postoperative Blood Transfusion for Frail Elderly With Hip Fracture

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01102010
First received: April 8, 2010
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

Elderly with hip fractures are often fragile 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. A low haemoglobin solution reduces the body's oxygen transport which causes an impaired functional level and strain on vital organs. Acute anaemia is also tolerated worse in elderly, than in younger patients. Therefore this study aim's is 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:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Functional ability [ Time Frame: Measured 10 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 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 after surgery ] [ Designated as safety issue: No ]
    Measurement by Depression List (DL)


Estimated Enrollment: 284
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 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 (9.8 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 senior housing to the Orthopaedic Surgery Ward at Aarhus University Hospital with hip fracture and treated operatively, are participants in the study. According to sample size calculations 284 patients are needed. Patients must before surgery give informed consent or there must be deputy informed consent if the patient is incompetent. Inclusion is dependent on if the outcome of haemoglobin is measured ≥ 6 and < 7mmol latest 6th days after surgery. Randomisation will be computerised. Randomisation will determine intervention with blood transfusion and the measurement of haemoglobin is blinded to patient, relatives and the primary sector. Both intervention, and control groups will receive blood when haemoglobin is less than 6 mmol/l, as recommended by the Danish Board of Health. Geriatric and Orthopaedic Team (GO-team), consisting of following trained specialists: physiotherapist, nurse and doctor, will conduct the medical examinations, including blood transfusions, from admission until 30 days after surgery. 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 nursing homes and in senior housing. Outcomes are functional ability after 10 days, quality of life and mortality after 30 days. The test for measuring the level of functionality and quality of life will be performed by a blinded therapist.

  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 senior housing
  • Haemoglobin level between 6 and 7 mmol/l latest 6th day after surgery
  • Written assent

Exclusion Criteria:

  • Active cancer
  • Pathological fracture
  • The patient is against blood transfusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102010

Contacts
Contact: Merete Gregersen, MHSc 0045 2962 4147 meregreg@rm.dk
Contact: Else Marie S Damsgaard, Professor 0045 8949 1931 elsedams@rm.dk

Locations
Denmark
Research Unit, Geriatric Department, Aarhus University Hospital Recruiting
Aarhus, Central Denmark Region, Denmark, 8000
Contact: Merete Gregersen, MHSc     0045 2962 4147     meregreg@rm.dk    
Contact: Else Marie S Damsgaard, Professor     0045 8949 1931     elsedams@rm.dk    
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 1, 2012
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on June 18, 2013