Effect of Postoperative Ferric Carboxymaltose

Knee Osteoarthritis Clinical Trial

Official title:

Effect of Postoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty : A Randomized, Controlled, Double-Blind Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03561480
• Other study ID #: Ferric Carboxymaltose 2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 11, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: June 2018
• Source: The Catholic University of Korea
• Contact: Yong In, MD, PhD
• Phone: 8290445228
• Email: iy1000[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Postoperative Anemia
• Total Knee Arthroplasty

Intervention

Drug:
• 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 .
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb increase from baseline till day of surgery	Hb increase from baseline till day of surgery	Postoperative 8 weeks from baseline
Secondary	Percentage of patients requiring alternative anaemia management therapy	Percentage of patients requiring alternative anaemia management therapy	Percentage of patients requiring alternative anaemia management therapy up to 8weeks
Secondary	Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )	Self-reported patient assessment of EQ-5D (EuroQol-5 dimension )	baseline and postoperative 4, 8 weeks
Secondary	WOMAC(Western Ontario and McMaster University Arthritis Index ) scale	WOMAC(Western Ontario and McMaster University Arthritis Index ) scale	baseline and postoperative 2, 4, 8 weeks
Secondary	Brief pain inventory	Brief pain inventory	baseline and postoperative 2, 4, 8 weeks