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

Primary Purpose

Anemia, Knee Arthropathy

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Iron Isomaltoside 1000

About this trial

This is an interventional prevention trial for Anemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.

Outcomes

Primary Outcome Measures

Postoperative anemia

Incidence of postoperative anemia at 30 days after surgery

Secondary Outcome Measures

Transfusion

Incidence and amount of red blood cell transfusion during admission

Hemoglobin

serum hemoglobin level (g/dL)

Hematocrit

Hematocrit level (%)

Iron

serum iron level (μg/dL)

Ferritin

serum ferritin level (ng/mL)

Transferrin saturation

Transferrin saturation (%)

Phosphorus

Serum phosphorus level (mg/dL)

Surgical site infection

Incidence of surgical site infection

Hospital length of stay

Hospital length of stay (days)

Quality of life using EQ-5D

Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire

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

Full Information

NCT ID

NCT03470649

First Posted

March 13, 2018

Last Updated

April 16, 2019

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03470649

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 29, 2018 (Actual)

Primary Completion Date

April 16, 2019 (Actual)

Study Completion Date

April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Knee Arthropathy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.

Intervention Type

Drug

Intervention Name(s)

Iron Isomaltoside 1000

Other Intervention Name(s)

treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative anemia

Description

Incidence of postoperative anemia at 30 days after surgery

Time Frame

30 days after surgery

Secondary Outcome Measure Information:

Title

Transfusion

Description

Incidence and amount of red blood cell transfusion during admission

Time Frame

During admission period for surgery, an average of 2 weeks

Title

Hemoglobin

Description

serum hemoglobin level (g/dL)

Time Frame