NCT01102010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 20, 2015

Status Verified

August 1, 2013

Enrollment Period

3.8 years

First QC Date

April 8, 2010

Last Update Submit

July 16, 2015

Conditions

Hip Fracture

Keywords

Blood transfusionHip fractureElderlyGeriatricsHospitalizationFrail elderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mortality

    Measured 30 and 90 days after surgery

  • Quality of Life

    Measured 30 days and 1 year after surgery

Other Outcomes (1)

  • Delirium

    Percentage of participants with delirium measured 10 days after surgery by the score 'Confusion Assessment Method'

Study Arms (1)

Blood transfusion

EXPERIMENTAL

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

Interventions

Blood transfusionBIOLOGICAL

An expanded indication for blood transfusion in the frail elderly

Blood transfusion

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active cancer
  • Pathological fracture
  • The patient is against blood transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit, Geriatric Department, Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

Related Publications (2)

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 12, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

July 20, 2015

Record last verified: 2013-08

Locations

DK(1)