NCT02800746

Brief Summary

The objective of the present study is to determine the impact of preoperative IV-iron (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood transfusion amount in patients undergoing elective prognathic surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Status
unknown

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

June 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

June 11, 2016

Last Update Submit

March 19, 2018

Conditions

Prognathic Surgery

Keywords

Prognathic surgeryintravenous iron

Outcome Measures

Primary Outcomes (1)

  • Serum-Hematocrit

    intergroup-difference immediately after surgery, %

    Postoperative 2 hour

Secondary Outcomes (3)

  • Serum-Ferritin level

    Postoperative 2 hour

  • Changes of serum-Ferritin level

    Postoperative 2 hour

  • Transfusion amount

    Postoperative 2 hour

Study Arms (2)

Experimental group

EXPERIMENTAL

Ferric carboxymaltose

Drug: Ferric carboxymaltose

Control Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ferric carboxymaltoseDRUG

Ferric carboxymaltose 15 mg/kg mg is intravenously administered on 7-10 day before surgery.

Experimental group
PlaceboDRUG

normal saline 100 ml is intravenously administered on 7-10 day before surgery

Also known as: normal saline
Control Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with prognathism in undergoing elective prognathic surgery
  • Patients provided a written informed consent.
  • Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
  • Patients with preoperative Hematocrit \> 39% (male) and \> 36% 9female)serum hemoglobin \>13 g/dL (male) and \>12 g/dL (female)

You may not qualify if:

  • Patients with history of anaphylaxis, iron overload, active infection.
  • Patients with endocrine disease
  • Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ferric carboxymaltoseSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Tae-Yop Kim, MD, PhD

CONTACT

82-2-2030-5445taeyop@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 15, 2016

Study Start

June 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share