Back to resultsIntraoperative IV Iron on Postoperative Red Blood Cell Recovery
Primary Purpose
Osteoarthritis, Hip
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ferric carboxymaltose
control
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring iron, arthroplasty, red blood cell
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ferric carboxymaltose 1000 mg
control
Arm Description
Ferric carboxymaltose is administered during surgery
Ferric carboxymaltose is not administered
Outcomes
Primary Outcome Measures
postoperative hematocrit (%)
hematocrit is evaluated on postoperative 7 days
Secondary Outcome Measures
volume of post-operative bleeding (ml)
total volume of postoperative bleeding collected in the drainage container (hemovac)
intraoperative blood transfusion (ml)
total volume of intraoperative blood transfusion
post-operative blood transfusion (ml)
total amount of post-operative blood transfusion (ml)
post-operative serum ferritin level (ng/ml)
post-operative serum ferritin level (ng/ml) is checked immediately after surgery
Full Information
NCT ID
NCT04035902
First Posted
July 21, 2019
Last Updated
August 17, 2020
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04035902
Brief Title
Intraoperative IV Iron on Postoperative Red Blood Cell Recovery
Official Title
Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
iron, arthroplasty, red blood cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ferric carboxymaltose 1000 mg
Arm Type
Experimental
Arm Description
Ferric carboxymaltose is administered during surgery
Arm Title
control
Arm Type
Active Comparator
Arm Description
Ferric carboxymaltose is not administered
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Intervention Description
Ferric carboxymaltose is administered during surgery
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
Ferric carboxymaltose is not administered
Primary Outcome Measure Information:
Title
postoperative hematocrit (%)
Description
hematocrit is evaluated on postoperative 7 days
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
volume of post-operative bleeding (ml)
Description
total volume of postoperative bleeding collected in the drainage container (hemovac)
Time Frame
7 day
Title
intraoperative blood transfusion (ml)
Description
total volume of intraoperative blood transfusion
Time Frame
1 day
Title
post-operative blood transfusion (ml)
Description
total amount of post-operative blood transfusion (ml)
Time Frame
7 days
Title
post-operative serum ferritin level (ng/ml)
Description
post-operative serum ferritin level (ng/ml) is checked immediately after surgery
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Yop Kim, MD PhD
Phone
0220305445
Email
taeyop@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intraoperative IV Iron on Postoperative Red Blood Cell Recovery
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