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Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04035902
Collaborator
(none)
46
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. postoperative hematocrit (%) [7 days after surgery]

    hematocrit is evaluated on postoperative 7 days

Secondary Outcome Measures

  1. volume of post-operative bleeding (ml) [7 day]

    total volume of postoperative bleeding collected in the drainage container (hemovac)

  2. intraoperative blood transfusion (ml) [1 day]

    total volume of intraoperative blood transfusion

  3. post-operative blood transfusion (ml) [7 days]

    total amount of post-operative blood transfusion (ml)

  4. post-operative serum ferritin level (ng/ml) [1 day]

    post-operative serum ferritin level (ng/ml) is checked immediately after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Konkuk University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tae-Yop Kim, MD PhD, Professor Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT04035902
Other Study ID Numbers:
  • KUH 2019-05-008
First Posted:
Jul 29, 2019
Last Update Posted:
Aug 19, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tae-Yop Kim, MD PhD, Professor Anesthesiology, Konkuk University Medical Center
iron
arthroplasty
red blood cell
Additional relevant MeSH terms:
Osteoarthritis, Hip

Study Results

No Results Posted as of Aug 19, 2020