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Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00906295
First received: May 20, 2009
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Condition Intervention
Anemia
Arthroplasty
Replacement
Hip
 Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L
Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Timed Up and Go-test (TUG)in seconds. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.


Secondary Outcome Measures:
  • The postoperative day patients can walk ten meters [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of stay at hospital [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • The day the patient is able to perform Timed Up and Go-test [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allowed drop in hemoglobin to 4.5-5.5 mmol/L
Transfusion with red blood cells to level between 4.5-5.5 mmol/L
 Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L
Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)
Experimental: Allowed drop in hemoglobin to 5.6-6.5 mmol/L
Transfusion with red blood cells to level between 5.6-6.5 mmol/L
 Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L
Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Patients undergoing replacement of hip arthroplasty
  • Be legally competent
  • Read and understand Danish

Exclusion Criteria:

  • Present malignant disease
  • Known heart disease with functionality equivalent to NYHA II or CCS II or worse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906295

Locations
Denmark
Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark, 2400
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Østerbro, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Kamilla Nielsen, MD Rigshospitalet, Denmark
  More Information

Additional Information:
Official hospital homepage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: MD Kamilla Nielsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00906295     History of Changes
Other Study ID Numbers: H-D-2009-024
Study First Received: May 20, 2009
Last Updated: June 3, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Hemoglobin
Ambulation

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013