Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of transfusion of red blood cells in treating postoperative dizziness in patients with moderate postoperative anemia after total hip arthroplasty.

Detailed Description
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Hip arthroplasty is associated with bleeding and postoperative anemia. However, the optimal strategy for transfusing red blood cells (RBC) remains to be elucidated. Postoperative anemia may cause dizziness and fatigue which delays early mobilization after surgery and may trigger the transfusion of one or more RBC units. However, it is not known whether the administration of 1-2 units of RBC to patients suffering from moderate postoperative anemia (HB 7.5 - 10 g/dl) will improve postoperative dizziness. Thus, this randomized controlled study aims to evaluate whether the administration of 1-2 RBC units on the first postoperative day improves postoperative dizziness in patients undergoing total hip arthroplasty.

Official Title
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Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Conditions
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Arthroplasty, Hip

Intervention / Treatment
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* Other: Red blood cell transfusion
* Drug: Voluven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 and able to give consent Hip arthroplasty or hip revision arthroplasty Haemoglobin > 4.8 mmol/L and < 6.0 mmol/L on the first postoperative day Dizziness score ≥ 2. Exclusion Criteria: Large ongoing bleeding Has already received RBC during the current admission New onset of cardiac arrhythmia suspected to be related to anemia Severe ischemic heart disease Renal failure with dialyses or oligouria / anuria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RBC transfusion<br>Administration of up to 2 RBC units on the first postoperative day. (1 unit at a time followed by evaluation of the primary outcome measure) | Other: Red blood cell transfusion<br>* Maximal 2 units of packed red blood cells given one at a time on the first postoperative day. Evaluation of primary outcome is done after administration of each unit.<br>|
| Placebo Comparator: Restrictive: Colloid infusion<br>Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention. | Drug: Voluven<br>* Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Dizziness scale | Dizziness scale (0-3) evaluated by the study nurse. The scale is evaluated upon information on the 1) severeness of dizziness AND 2) it´s consequenses for early mobilization after surgery. 0 - No dizziness. - Light dizziness / No consequences for mobilization - Moderate dizziness / Only shorter periods of mobilization possible - Severe dizziness / No or only short bedside mobilization possible | Day 1 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and go test (TUG) | Measures the time it take the subject to rise from a chair, walk 3 meters and return to the chair. | Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery) | 
| Fatigue score | Numeric rating scale 0-10, measuring subjective feeling of fatigue. | Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery) | 
| FACT-Anemia scale | Validated subjective score addressing anemia related symptoms. | 7 and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfusion, Red blood cells, Postoperative, Dizziness, Hip Arthroplasty