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Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00906295
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : June 6, 2011
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment
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  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Study Start Date : June 2009
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Timed Up and Go-test (TUG)in seconds. [ Time Frame: 30 days ]
    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 :
  1. The postoperative day patients can walk ten meters [ Time Frame: 30 days ]
  2. Length of stay at hospital [ Time Frame: 30 days ]
  3. The day the patient is able to perform Timed Up and Go-test [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MD Kamilla Nielsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00906295     History of Changes
Other Study ID Numbers: H-D-2009-024
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: June 6, 2011
Last Verified: June 2011

Keywords provided by Rigshospitalet, Denmark:
Hemoglobin
Ambulation