Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

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.

Study Overview

• Status: Terminated
• Conditions: Arthroplasty, Hip
• Intervention / Treatment: Other: Red blood cell transfusion; Drug: Voluven

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark
    • Gentofte Hospital, Department of orthopedic surgery
  • Vejle, Denmark
    • Vejle Sygehus, Department of orthopedic surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Other: 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.
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Oeivind Jans, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Hip Arthroplasty; Postoperative; Transfusion; Dizziness; Red blood cells
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: H-4-2011-058