Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

Konkuk University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis, Hip

Treatments: Drug: control; Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT04035902

KUH 2019-05-008

Details and patient eligibility

About

The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative recovery of RBC mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without IV-iron supplementation during surgery

Enrollment: 46 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
• Patients provided a written informed consent.
• Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)
• Patients with preoperative serum hemoglobin concentration >10 g/dL

Exclusion criteria

• Patients with history of anaphylaxis, iron overload, active infection.
• Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

ferric carboxymaltose 1000 mg

Experimental group

Description:

Ferric carboxymaltose is administered during surgery

Treatment:

Drug: Ferric carboxymaltose

control

Active Comparator group

Description:

Ferric carboxymaltose is not administered

Treatment:

Drug: control