Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Not Applicable

Terminated

• Conditions: Arthroplasty, Hip
• Interventions: Other: Red blood cell transfusion; Drug: Voluven

• Registration Number: NCT01452581
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RBC transfusion	Red blood cell transfusion	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)
Restrictive: Colloid infusion	Voluven	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Dizziness scale	Day 1 after surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Gentofte Hospital, Department of orthopedic surgery; 🇩🇰 Gentofte, Denmark

Vejle Sygehus, Department of orthopedic surgery; 🇩🇰 Vejle, Denmark