Intravenous Iron Sucrose in Arthroplasty
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Iron Sucrose 200mg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, knee arthroplasty, iron
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 >13 g/dL (male) and >12 g/dL (female)
- Patients with PaO2/FiO2 ratio >150
Exclusion Criteria:
- Patients with history of anaphylaxis, iron overload, active infection.
- Patients with endocrine disease
- Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control Group
Arm Description
Iron Sucrose 200mg
placebo
Outcomes
Primary Outcome Measures
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Intergroup-difference in PaO2/FiO2 ratio
Secondary Outcome Measures
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
intergroup-difference in PaO2/FiO2 ratio
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
intergroup-difference in PaO2/FiO2 ratio
serum hemoglobin concentration
serum hemoglobin concentration, g/dL
postoperative transfusion red blood cell amount
postoperative transfusion of packed red blood cell, ml
Full Information
NCT ID
NCT02544828
First Posted
September 6, 2015
Last Updated
September 8, 2015
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02544828
Brief Title
Intravenous Iron Sucrose in Arthroplasty
Official Title
Does Intraoperative Intravenous Iron Sucrose Enhance Postoperative Oxygenation Profile in Total Arthroplasty Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
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 oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb arthroplasty surgery.
Detailed Description
Participation and recruitment: Patients undergoing elective total knee arthroplasty due to osteroarthritis will be interviewed for participation and recruited after providing written informed consent.
Randomization and group allocation:
All recruited patients will be given patient identification number (PIN) for the present study of 01-76 according to their order of interview and recruitment.
Investigators will prepare 33 yellow and 33 green cards, which will be inserted in 76 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 76 (Envelop number).
After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.
Preparation and Administration of study drug:
Pharmacist will open the envelope with the number same to PIN and check the color of the card inside at study on operation day.
According to the color of the card, IV-iron or placebo will be prepared for the patient: IV-iron for yellow card; placebo for green cards, respectively.
The study drug will be covered by black-tape by pharmacist and delivered to the operation theater.
IV-iron or placebo will be infused through already established intravenous line within 30 min after anesthesia induction by attending anesthesiologist who is not aware of the patient's group-allocation.
Patient data and statistical analyses:
The information regarding the patient's group allocation will be kept in the pharmacy department till the end of the study and conveyed during the data analyses after completion of the 76th patient participation and discharge.
Patient's data PaO2, FiO2, Hb, intra-op and postop-transfusion amount, intraop- and postop-bleeding amount will be determined from the patients' medical record after patient's discharge.
All statistical analyses will be performed after the 76th patient's discharge and data acquisition.
Surgical procedures:
All surgical procedures will be performed using standardized institutional anesthetic and surgical protocols, antibiotic and antithrombotic prophylaxis, transfusion protocols, and post-operative analgesia.
All TKA will be performed using a pneumatic tourniquet, which is deflated after wound closure. Closed suction drains, which are removed on the second post-operative day, will be placed in all operations.
Transfusion protocol:
Following allogenic blood transfusion protocol will be uniformly applied by anesthesiologists and surgeons to all patients in the operating theater, the post-operative anesthesia care unit, and the ward for the entire duration of hospitalization: blood transfusion of packed RBC will not be performed unless patient's Hb level is < 9 g/dL without any signs and/or symptoms of acute anemia such as hypotension, tachycardia, tachypnea, dizziness, and fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, knee arthroplasty, iron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Iron Sucrose 200mg
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose 200mg
Intervention Description
Iron Sucrose 200mg is administered after anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline
Intervention Description
placebo (normal saline) is administered after anesthesia induction
Primary Outcome Measure Information:
Title
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Description
Intergroup-difference in PaO2/FiO2 ratio
Time Frame
postoperative 24 hour
Secondary Outcome Measure Information:
Title
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Description
intergroup-difference in PaO2/FiO2 ratio
Time Frame
postoperative 2 hour
Title
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Description
intergroup-difference in PaO2/FiO2 ratio
Time Frame
postoperative 48 hour
Title
serum hemoglobin concentration
Description
serum hemoglobin concentration, g/dL
Time Frame
postoperative 2 hour
Title
postoperative transfusion red blood cell amount
Description
postoperative transfusion of packed red blood cell, ml
Time Frame
postoperative 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 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 >13 g/dL (male) and >12 g/dL (female)
Patients with PaO2/FiO2 ratio >150
Exclusion Criteria:
Patients with history of anaphylaxis, iron overload, active infection.
Patients with endocrine disease
Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or 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
82-2-2030-5445
Email
taeyop@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Intravenous Iron Sucrose in Arthroplasty
We'll reach out to this number within 24 hrs