Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Not Applicable

Completed

• Conditions: Anemia; Arthroplasty; Replacement; Hip
• Interventions: 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

• Registration Number: NCT00906295
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Study Start: 2009-06
• Primary Completion: 2011-05
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allowed drop in hemoglobin to 4.5-5.5 mmol/L	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
Allowed drop in hemoglobin to 5.6-6.5 mmol/L	Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L	Transfusion with red blood cells to level between 5.6-6.5 mmol/L

Primary Outcome Measures

Name	Time	Method
Timed Up and Go-test (TUG)in seconds.	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

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

Trial Locations

Locations (2)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen NV, Denmark

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Østerbro, Denmark