Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2011

Interventions

  • 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)
  • 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)

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The postoperative day patients can walk ten meters
    • Time Frame: 30 days
  • Length of stay at hospital
    • Time Frame: 30 days
  • The day the patient is able to perform Timed Up and Go-test
    • Time Frame: 30 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • TrygFonden, Denmark
  • Provider of Information About this Clinical Study
    • MD Kamilla Nielsen, Rigshospitalet
  • Overall Official(s)
    • Kamilla Nielsen, MD, Principal Investigator, Rigshospitalet, Denmark

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.