Intraoperative IV Iron on Postoperative Red Blood Cell Recovery
Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery
1 other identifier
interventional
46
0 countries
N/A
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
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 Mar 2021
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
July 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 19, 2020
August 1, 2020
9 months
July 21, 2019
August 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative hematocrit (%)
hematocrit is evaluated on postoperative 7 days
7 days after surgery
Secondary Outcomes (4)
volume of post-operative bleeding (ml)
7 day
intraoperative blood transfusion (ml)
1 day
post-operative blood transfusion (ml)
7 days
post-operative serum ferritin level (ng/ml)
1 day
Study Arms (2)
ferric carboxymaltose 1000 mg
EXPERIMENTALFerric carboxymaltose is administered during surgery
control
ACTIVE COMPARATORFerric carboxymaltose is not administered
Interventions
Ferric carboxymaltose is administered during surgery
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Anesthesiology
Study Record Dates
First Submitted
July 21, 2019
First Posted
July 29, 2019
Study Start
March 1, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
August 19, 2020
Record last verified: 2020-08