Intravenous Iron Sucrose in Arthroplasty
Does Intraoperative Intravenous Iron Sucrose Enhance Postoperative Oxygenation Profile in Total Arthroplasty Surgery?
1 other identifier
interventional
76
0 countries
N/A
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.
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 Nov 2015
Shorter than P25 for phase_4
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 6, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 9, 2015
September 1, 2015
8 months
September 6, 2015
September 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
Intergroup-difference in PaO2/FiO2 ratio
postoperative 24 hour
Secondary Outcomes (4)
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
postoperative 2 hour
arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
postoperative 48 hour
serum hemoglobin concentration
postoperative 2 hour
postoperative transfusion red blood cell amount
postoperative 24 hour
Study Arms (2)
Experimental group
EXPERIMENTALIron Sucrose 200mg
Control Group
PLACEBO COMPARATORplacebo
Interventions
Iron Sucrose 200mg 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 \>13 g/dL (male) and \>12 g/dL (female)
- Patients with PaO2/FiO2 ratio \>150
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 6, 2015
First Posted
September 9, 2015
Study Start
November 1, 2015
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
September 9, 2015
Record last verified: 2015-09