Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

Rigshospitalet

Status: Terminated

Conditions: Arthroplasty, Hip

Treatments: Other: Red blood cell transfusion; Drug: Voluven

Study type: Interventional

Funder types: Other

Identifiers

NCT01452581

H-4-2011-058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups, including a placebo group

RBC transfusion

Active Comparator group

Description:

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)

Treatment:

Other: Red blood cell transfusion

Restrictive: Colloid infusion

Placebo Comparator group

Description:

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.

Treatment:

Drug: Voluven