Does Intraoperative Intravenous Iron Enhance Postoperative Oxygenation Profile in Total Knee Arthroplasty Surgery?
1 other identifier
interventional
76
1 country
1
Brief Summary
The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb total knee arthroplasty surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedSeptember 19, 2019
September 1, 2019
2.3 years
September 3, 2015
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The changes of Hemoglobin between preoperative and postoperative day 30
intergroup-difference in hemoglobin change
postoperative 30 days
the changes of arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
intergroup-difference in PaO2/FiO2 ratio
postoperative 5 days
Secondary Outcomes (6)
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
postoperative 1 day
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
postoperative 3 days
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
postoperative 5 days
serum hemoglobin concentration
postoperative 1 day
serum hemoglobin concentration
postoperative 5 days
- +1 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALferric carboxymaltose 1000 mg
Control group
PLACEBO COMPARATORplacebo
Interventions
Ferric carboxymaltose is administered after anesthesia induction
placebo (normal saline) is administered after anesthesia induction
Eligibility Criteria
You may qualify if:
- 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
- Patients with PaO2/FiO2 ratio \>150
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Konkuk University Medical Centerlead
- Asan Medical Centercollaborator
Study Sites (1)
Konkuk University Medical Center & Asan Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 3, 2015
First Posted
September 9, 2015
Study Start
August 1, 2016
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
September 19, 2019
Record last verified: 2019-09