Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

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.

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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.

Conditions

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Arthroplasty, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RBC 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)

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

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.

Restrictive: Colloid infusion

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.

Group Type PLACEBO_COMPARATOR

Voluven

Intervention Type DRUG

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.

Interventions

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Red blood cell transfusion

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.

Intervention Type OTHER

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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No