Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04035902

Enrollment

Registered

2019-07-29

Start date

2021-03-31

Completion date

2021-12-31

Last updated

2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

Keywords

iron, arthroplasty, red blood cell

Brief summary

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

Interventions

DRUGFerric carboxymaltose

Ferric carboxymaltose is administered during surgery

DRUGcontrol

Ferric carboxymaltose is not administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
postoperative hematocrit (%)	7 days after surgery	hematocrit is evaluated on postoperative 7 days

Secondary

Measure	Time frame	Description
volume of post-operative bleeding (ml)	7 day	total volume of postoperative bleeding collected in the drainage container (hemovac)
intraoperative blood transfusion (ml)	1 day	total volume of intraoperative blood transfusion
post-operative blood transfusion (ml)	7 days	total amount of post-operative blood transfusion (ml)
post-operative serum ferritin level (ng/ml)	1 day	post-operative serum ferritin level (ng/ml) is checked immediately after surgery

Contacts

Primary ContactTae-Yop Kim, MD PhD

taeyop@gmail.com0220305445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026