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
  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:


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
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: 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:
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

ClinicalTrials.gov processed this record on October 23, 2014