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Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00906295
Enrollment
67
Registered
2009-05-21
Start date
2009-06-30
Completion date
2011-06-30
Last updated
2011-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Arthroplasty, Hip, Replacement

Keywords

Hemoglobin, Ambulation

Brief summary

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

Interventions

OTHERAllowed 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)

OTHERAllowed 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)

Sponsors

TrygFonden, Denmark
CollaboratorINDUSTRY
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Timed Up and Go-test (TUG)in seconds.30 daysTimed 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

MeasureTime frame
The postoperative day patients can walk ten meters30 days
Length of stay at hospital30 days
The day the patient is able to perform Timed Up and Go-test30 days

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026