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

NCT03528564 | Terminated Phase 2 FDA Drug

• 1 other identifier: HOPE-Hb
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preoperative Anemia; Intravenous Iron; Erythropoietin

Outcome Measures

Primary Outcomes (2)

• Vanguard Phase (Initial 12 patients): Feasibility of using Erythropoietin + Intravenous Iron to Treat Preoperative Iron Restrictive Anemia

  The primary outcome of the vanguard phase is to determine the feasibility of using erythropoietin + intravenous iron to treat preoperative iron restrictive anemia. Feasibility will be measured according to subject enrollment rates, with adherence to the treatment schedule of \>80%.

  18 weeks from randomization

• Full Study: Preoperative Hemoglobin Concentration

  The primary outcome of the full study is preoperative hemoglobin concentration, as measured on the day of surgery in patients with iron restricted anemia.

  6 weeks from randomization

Secondary Outcomes (18)

• Post-Treatment Hemoglobin Concentration

  12 weeks from randomization

• Change in Hemoglobin Concentration from Initiation of Treatment

  6 weeks from randomization

• Postoperative Hemoglobin Concentration

  0 weeks from surgery and 12 weeks from surgery

• Red Blood Cell Transfusions

  6 weeks from surgery

• Deep Vein Thrombosis

  12 weeks from surgery

Study Arms (2)

Epoetin alfa

EXPERIMENTAL

Preoperative treatment of anemia with iron sucrose (Venofer) plus Epoetin Alfa (Eprex)

Drug: Iron sucrose; Drug: Epoetin Alfa

Intravenous Iron

PLACEBO COMPARATOR

Preoperative treatment of anemia with iron sucrose (Venofer) plus placebo (saline)

Drug: Iron sucrose; Drug: Placebo

Interventions

Iron sucrose DRUG

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

Also known as: Venofer

Epoetin alfa; Intravenous Iron

Epoetin Alfa DRUG

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

Also known as: Eprex

Epoetin alfa

Placebo DRUG

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

Also known as: Saline

Intravenous Iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at the time of consent
• Undergoing unilateral total hip or knee arthroplasty surgery (primary)
• Hemoglobin concentration of less than 120g/L; but greater than 60g/L

You may not qualify if:

• Anemia attributed to something other than iron deficiency anemo/ACI:
• Any other diagnosed or suspected cause of anemia (e.g. macrocytic anemia , lead toxicity, myelodysplastic syndrome)
• Suspected of having acute blood loss due to any diagnosed condition (e.g. malignancy or gastric ulcer)
• Mean Cell Volume (MCV) \> 97fL
• Known deficiency of vitamin B12 and/or folate
• A known history of acquired iron overload, haemochromatosis, thalassemia or other hereditary hemoglobinopathy.
• Received an erythropoiesis stimulating agent, IV iron therapy, or red blood cell transfusion in the previous 12 weeks (from the time of consent), or planned use prior to operation
• Blood pressure measured at \>180mmHg systolic or \>100mmHg diastolic
• Known current or prior history of liver disease or elevation of alanine transaminase (ALT), or aspartate transaminase (AST) more than two times the upper limit of normal
• A known hypersensitivity to IV iron or erythropoietin alfa (Eprex)
• Renal dialysis (current or historical)
• Active infection (currently receiving antibiotics)
• Not eligible for venous thromboembolism prophylaxis
• Prior history of seizures or medical conditions associated with a predisposition to seizure activity such as central nervous system infections and brain metastases
• History of thromboembolic disease or active coronary artery disease

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hosptial

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferric Oxide, Saccharated; Epoetin Alfa; Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Gregory MT Hare, MD PhD

  St. Michael's Hospital; University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 18, 2018
• Study Start: July 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

CA (1)