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Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia

NCT03528564 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-06-18

No results posted yet for this study

Summary

The HOPE-Hb trial is a phase II study to determine the feasibility and impact of a combination treatment (intravenous iron plus erythropoietin) versus intravenous iron treatment alone on preoperative hemoglobin concentration before hip or knee arthroplasty.

Conditions

  • Anemia, Iron Deficiency
  • Anemia of Chronic Disease
  • Hip Arthropathy
  • Knee Arthropathy

Interventions

DRUG

Iron sucrose

Intravenous iron to be administered to all patients (9 x 5 mL Single Dose Vials @ 20mg elemental iron/mL; 900 mg total)

DRUG

Epoetin Alfa

Erythropoietin to be administered to half of study participants (40,000 IU x 1-2 subcutaneous injections)

DRUG

Placebo

Saline to be administered to half of study participants (equal volume to Eprex x 1-2 subcutaneous injections)

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Gregory MT Hare, MD PhD · St. Michael's Hospital; University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03528564 on ClinicalTrials.gov