Intraoperative IV Iron on Postoperative Red Blood Cell Re... | NCT04035902

Studies
Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

NCT04035902

Sponsor

Konkuk University Medical Center

Status

Unknown status

Last Update Posted

Aug 19, 2020Actual

Enrollment

46Estimated

Phase

Phase 4

Conditions

Osteoarthritis, Hip

Interventions

Ferric carboxymaltose
control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2021Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jul 21, 2019

First Submission Date that Met QC Criteria

Jul 26, 2019

First Posted Date

Jul 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2020

Last Update Posted Date

Aug 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tae-Yop Kim, MD PhD, Professor Anesthesiology, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ferric carboxymaltose 1000 mg	Experimental	Ferric carboxymaltose is administered during surgery	Drug: Ferric carboxymaltose
control	Active Comparator	Ferric carboxymaltose is not administered	Drug: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ferric carboxymaltose	Drug	Ferric carboxymaltose is administered during surgery	ferric carboxymaltose 1000 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative hematocrit (%)	hematocrit is evaluated on postoperative 7 days	7 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
volume of post-operative bleeding (ml)	total volume of postoperative bleeding collected in the drainage container (hemovac)	7 day
intraoperative blood transfusion (ml)	total volume of intraoperative blood transfusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-Yop Kim, MD PhD	Contact	0220305445		taeyop@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided