Effect of Postoperative Ferric Carboxymaltose

NCT ID: NCT03561480

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-12-11

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).

Detailed Description

Both preoperative and postoperative anaemia are common in patients undergoing total knee arthroplasty. Allogeneic RBC (red blood cell) transfusion and anaemia are related with higher postoperative mortality and morbidity. It is important to have a strategy of patient blood management.

Hb(hemoglobin) level of 10 g/dl will be used as a cut-off value for our study. In postoperative period in total knee arthroplasty for osteoarthritis, consented patients with postoperative anemia will be administered Ferinject® or placebo (normal saline) based on the results of randomization.

Study Group: Ferinject® administration as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg(milligram) single administration) for body weight ≥50 Kg (kilogram) or 6 minutes (for 500mg(milligram) single administration) for body weight < 50Kg( kilogram) .

Control Group: Placebo in the form of normal saline administration as same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL(milliliter) as infusion or 20mL(milliliter) as bolus injection) for body weight ≥50 Kg ( kilogram) or 6 minutes (100mL normal as infusion or 10mL(milliliter) as bolus injection) for body weight <50 Kg (kilogram).

Conditions

Postoperative Anemia; Knee Osteoarthritis; Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ferric carboxymaltose group

Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with postoperative anemia after total knee arthroplasty.

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .

Placebo group

Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with postoperative anemia after total knee arthroplasty.

Group Type: ACTIVE_COMPARATOR

0.9% Normal Saline

Intervention Type: DRUG

Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.

Interventions

Ferric carboxymaltose

Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .

Intervention Type: DRUG

0.9% Normal Saline

Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.

Intervention Type: DRUG

Other Intervention Names

Ferinject®

Eligibility Criteria

Inclusion Criteria

• > 18 years of age and signed written informed consent
• Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
• Hb < 10.0 g/dl after operation
• Ferritin < 100 μg/l or 100-300 with transferrin saturation < 20%

Exclusion Criteria

• Suspicion of iron overload (Ferritin >300 μg/l or/and transferrin saturation>50%)
• Active severe infection/inflammation (defined as serum C reactive protein > 20 mg/l) or diagnosed malignancy
• Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
• Known history of hepatitis B/C or HIV-positive
• Liver values 3 times higher than normal
• Immunosuppressive or myelosuppressive therapy
• A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
• Pregnancy or lactation
• Transfusion within 1 month prior to study inclusion, erythropoietin treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
• Participation in any other therapeutic trial within the previous month
• History of thromboembolic events in the family or the patient
• Severe peripheral, coronary or carotid artery disease
• Bodyweight < 50 kg
• Patients not able to understand the German language

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Yong In

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong In, MD, PhD

Role: STUDY_CHAIR

The Catholic Univerisity of Korea Seoul St Mary's hospital

Central Contacts

Yong In, MD, PhD

Role: CONTACT

iy1000@catholic.ac.kr

8290445228

Man Soo Kim, MD

Role: CONTACT

kms3779@naver.com

8272333875

Other Identifiers

Ferric Carboxymaltose 2

Identifier Type: -

Identifier Source: org_study_id