NCT01012063

Brief Summary

The object of this study is to evaluate whether low dose intravenous iron and erythropoietin (Epo) can decrease transfusion requirement after the bilateral TKRA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

November 10, 2009

Last Update Submit

August 16, 2013

Conditions

AnemiaTransfusion

Keywords

ironerythropoietinhemoglobinTotal knee replacement arthroplasty

Outcome Measures

Primary Outcomes (1)

  • postoperative hemoglobin

    postoperative 1, 2, 3, 5 day and 2, 6 week

Secondary Outcomes (1)

  • serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)

    preoperation and postoperation

Study Arms (2)

group IE

EXPERIMENTAL

The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation

Drug: iron sucrose, erythropoietin-β

group C

PLACEBO COMPARATOR

The group C received saline as same method.

Drug: normal saline

Interventions

iron sucrose, erythropoietin-βDRUG

The 200 mg of iron sucrose diluted with 100 ml of normal saline was given intravenously over one hour and the 3000 IU of Epo-β was injected subcutaneously.

Also known as: Venoferrum, recormon
group IE
normal salineDRUG

100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.

Also known as: sodium chloride
group C

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients undergoing bilateral total knee replacement arthroplasty
  • American society of anesthesiologist class 1-3
  • Hb\>100 g/L
  • Either serum ferritin\<100 ng/ml or 100\<ferritin\<300 ng/ml with a transferrin saturation (TSAT) \<20%

You may not qualify if:

  • Hematologic disease
  • Thromboembolic disease
  • Hepatic or renal disease
  • Coagulation disorder
  • Infection
  • Malignancy
  • Under anticoagulant therapy
  • Hypersensitivity to iron sucrose or Epo
  • Preoperative autologous blood donation
  • Use of iron or Epo and blood transfusion within the previous 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharatedepoetin betaSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Hyoseok Na, pf

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

August 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

KR(1)