Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients

Anemia Clinical Trial

Official title:

Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470649
• Other study ID #: H-1709-079-885
• Status: Completed
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: April 17, 2019

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 17, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Joint Diseases
• Knee Arthropathy

Intervention

Drug:
• Iron Isomaltoside 1000
Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative anemia	Incidence of postoperative anemia at 30 days after surgery	30 days after surgery
Secondary	Transfusion	Incidence and amount of red blood cell transfusion during admission	During admission period for surgery, an average of 2 weeks
Secondary	Hemoglobin	serum hemoglobin level (g/dL)	1 day, 7 days, and 30 days after surgery
Secondary	Hematocrit	Hematocrit level (%)	1 day, 7 days, and 30 days after surgery
Secondary	Iron	serum iron level (µg/dL)	1 day, 7 days, and 30 days after surgery
Secondary	Ferritin	serum ferritin level (ng/mL)	1 day, 7 days, and 30 days after surgery
Secondary	Transferrin saturation	Transferrin saturation (%)	1 day, 7 days, and 30 days after surgery
Secondary	Phosphorus	Serum phosphorus level (mg/dL)	1 day, 7 days, and 30 days after surgery
Secondary	Surgical site infection	Incidence of surgical site infection	During admission period for surgery, an average of 2 weeks
Secondary	Hospital length of stay	Hospital length of stay (days)	During admission period for surgery, an average of 2 weeks
Secondary	Quality of life using EQ-5D	Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire	30 days after surgery
Secondary	Quality of life using FACT-An	Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire	30 days after surgery