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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBC transfusion | Active Comparator | 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) |
|
| Restrictive: Colloid infusion | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell transfusion | 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. |
| 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.
| Day 1 after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oeivind Jans, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital, Department of orthopedic surgery | Gentofte Municipality | Denmark | ||||
| Vejle Sygehus, Department of orthopedic surgery |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| C485123 | HES 130-0.4 |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Voluven | 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. |
|
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 |
| Vejle |
| Denmark |