NCT01676740

Brief Summary

To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

August 29, 2012

Last Update Submit

August 31, 2012

Conditions

Excessive Amount of Blood / Fluid Transfusion

Keywords

hematinic therapyblood transfusionjoint replacement

Outcome Measures

Primary Outcomes (1)

  • Perioperative blood transfusion

    1 day prior to surgery until hospital discharge

Study Arms (3)

Mild anemia, normal hematinics

PLACEBO COMPARATOR

Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo

Drug: Placebo

Anemia, normal hematinics

EXPERIMENTAL

Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given

Drug: Iron Supplement,

Deficeicnt hematinics

OTHER

Iron supplement will be provided

Drug: Iron Supplement,

Interventions

Iron Supplement,DRUG

Pills to be swallowed

Also known as: Ferrifol
Anemia, normal hematinicsDeficeicnt hematinics
PlaceboDRUG

Daily administration of active drug or placebo

Mild anemia, normal hematinics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years
  • Ability to provide informed consent
  • Elective THR or TKR
  • Mild anemia: Hematocrit 29-39% in men, 29-36% in women

You may not qualify if:

  • Identified cause of anemia excluding hematinic deficiency
  • Known source of blood loss
  • Known coagulopathy
  • Unstable coronary syndrome in the previous 3 months
  • Pathologic fracture, presence of malignancy
  • Repeat THR or TKR
  • Orthopedic trauma within the previous 3 months
  • ASA class ≥ 4
  • Creatinine clearance \< 30 ml/min
  • AST/ALT \> 2x upper limit of normal
  • Preexisting use of hematinic agents
  • Planned acute normovolemic hemodilution
  • Refusal to receive blood products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Interventions

Iron-Dextran Complex

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Martin H Ellis, MD

    Meir Medical Center

    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
Head Hematology Institute

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

IL(1)