- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035902
Intraoperative IV Iron on Postoperative Red Blood Cell Recovery
August 17, 2020 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center
Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tae-Yop Kim, MD PhD
- Phone Number: 0220305445
- Email: taeyop@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ferric carboxymaltose 1000 mg
Ferric carboxymaltose is administered during surgery
|
Ferric carboxymaltose is administered during surgery
|
Active Comparator: control
Ferric carboxymaltose is not administered
|
Ferric carboxymaltose is not administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative hematocrit (%)
Time Frame: 7 days after surgery
|
hematocrit is evaluated on postoperative 7 days
|
7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
volume of post-operative bleeding (ml)
Time Frame: 7 day
|
total volume of postoperative bleeding collected in the drainage container (hemovac)
|
7 day
|
intraoperative blood transfusion (ml)
Time Frame: 1 day
|
total volume of intraoperative blood transfusion
|
1 day
|
post-operative blood transfusion (ml)
Time Frame: 7 days
|
total amount of post-operative blood transfusion (ml)
|
7 days
|
post-operative serum ferritin level (ng/ml)
Time Frame: 1 day
|
post-operative serum ferritin level (ng/ml) is checked immediately after surgery
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
July 21, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (Actual)
July 29, 2019
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 17, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH 2019-05-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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