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.

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
Drug: Ferric carboxymaltose
Ferric carboxymaltose is administered during surgery
Active Comparator: control
Ferric carboxymaltose is not administered
Drug: control
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

Konkuk University Medical Center

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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