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

• Status: Terminated
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: Epoetin Alfa; Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

• Women who are pregnant or lactating (women of childbearing potential must be surgically sterile, or more than 1 year postmenopausal, or else must have a negative pregnancy test prior to randomization)

• Recipient of an investigational drug within the past 30 days

• Inability to speak, read, or understand the English language (required for cognitive testing)

• Participation in a preoperative autologous blood donation program for current operation