Arthroplasty, Hip
Conditions
Keywords
Transfusion, Red blood cells, Postoperative, Dizziness, Hip Arthroplasty
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.
Interventions
OTHERRed 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.
DRUGVoluven
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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed