Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

Study Overview
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Brief Summary
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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

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

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Drug: Ferric carboxymaltose
* Drug: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ferric carboxymaltose 1000 mg<br>Ferric carboxymaltose is administered during surgery | Drug: Ferric carboxymaltose<br>* Ferric carboxymaltose is administered during surgery<br>|
| Active Comparator: control<br>Ferric carboxymaltose is not administered | Drug: control<br>* Ferric carboxymaltose is not administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hematocrit (%) | hematocrit is evaluated on postoperative 7 days | 7 days after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, arthroplasty, red blood cell