Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Rigshospitalet

Status: Completed

Conditions: Anemia; Arthroplasty; Replacement; Hip

Treatments: 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

Funder types: Other; Industry

Identifiers

NCT00906295

H-D-2009-024

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 2 patient groups

Allowed drop in hemoglobin to 4.5-5.5 mmol/L

Active Comparator group

Description:

Transfusion with red blood cells to level between 4.5-5.5 mmol/L

Treatment:

Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L

Allowed drop in hemoglobin to 5.6-6.5 mmol/L

Experimental group

Description:

Transfusion with red blood cells to level between 5.6-6.5 mmol/L

Treatment:

Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L