- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03470649
Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.
Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.
The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Seoul, Korea, Republiken av, 03080
- Seoul National University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult patients undergoing total knee arthroplasty
Exclusion Criteria:
- bilateral total knee arthroplasty
- hematochromatosis or hemosiderosis
- hemolytic anemia
- history of drug allergy
- liver cirrhosis or hepatitis
- systematic lupus erythematosus
- rheumatic arthritis
- allergic disease
- history of transfusion within one month from surgery
- parturient
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment
Patients in this group would receive Iron Isomaltoside 1000 (Monofer®) after main procedure of total knee arthroplasty.
The dose of iron isomaltoside would be determined based on the patient's body weight.
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Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
Andra namn:
|
Inget ingripande: Control
Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Postoperative anemia
Tidsram: 30 days after surgery
|
Incidence of postoperative anemia at 30 days after surgery
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30 days after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Transfusion
Tidsram: During admission period for surgery, an average of 2 weeks
|
Incidence and amount of red blood cell transfusion during admission
|
During admission period for surgery, an average of 2 weeks
|
Hemoglobin
Tidsram: 1 day, 7 days, and 30 days after surgery
|
serum hemoglobin level (g/dL)
|
1 day, 7 days, and 30 days after surgery
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Hematocrit
Tidsram: 1 day, 7 days, and 30 days after surgery
|
Hematocrit level (%)
|
1 day, 7 days, and 30 days after surgery
|
Iron
Tidsram: 1 day, 7 days, and 30 days after surgery
|
serum iron level (μg/dL)
|
1 day, 7 days, and 30 days after surgery
|
Ferritin
Tidsram: 1 day, 7 days, and 30 days after surgery
|
serum ferritin level (ng/mL)
|
1 day, 7 days, and 30 days after surgery
|
Transferrin saturation
Tidsram: 1 day, 7 days, and 30 days after surgery
|
Transferrin saturation (%)
|
1 day, 7 days, and 30 days after surgery
|
Phosphorus
Tidsram: 1 day, 7 days, and 30 days after surgery
|
Serum phosphorus level (mg/dL)
|
1 day, 7 days, and 30 days after surgery
|
Surgical site infection
Tidsram: During admission period for surgery, an average of 2 weeks
|
Incidence of surgical site infection
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During admission period for surgery, an average of 2 weeks
|
Hospital length of stay
Tidsram: During admission period for surgery, an average of 2 weeks
|
Hospital length of stay (days)
|
During admission period for surgery, an average of 2 weeks
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Quality of life using EQ-5D
Tidsram: 30 days after surgery
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Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire
|
30 days after surgery
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Quality of life using FACT-An
Tidsram: 30 days after surgery
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Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire
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30 days after surgery
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Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-1709-079-885
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