Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Postoperative Dizziness scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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)
Intervention: Red blood cell transfusion (Other)
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.
Intervention: Voluven (Drug)
Outcomes
Primary Outcomes
Postoperative Dizziness scale
Time Frame: 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 Outcomes
- Timed up and go test (TUG)(Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery))
- Fatigue score(Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery))
- FACT-Anemia scale(7 and 14 days)
Investigators
Oeivind Jans
M.D, Clinical Assitant
Rigshospitalet, Denmark