Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Rigshospitalet, Denmark5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Arthroplasty, Hip

Interventions

Red blood cell transfusionOTHER

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.

VoluvenDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Gentofte Hospital, Department of orthopedic surgery

Gentofte Municipality, Denmark

Vejle Sygehus, Department of orthopedic surgery

Vejle, Denmark

Outcomes

Primary Outcomes

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. 1. \- Light dizziness / No consequences for mobilization 2. \- Moderate dizziness / Only shorter periods of mobilization possible 3. \- Severe dizziness / No or only short bedside mobilization possible

Time frame: Day 1 after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 7 and 14 days

Data from ClinicalTrials.gov

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