Hemoglobin Optimization to Prevent Transfusion & Adverse Events in

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The purpose of the HOPE-Hb trial is to determine the feasibility and efficacy of intravenous iron plus erythropoietin versus intravenous iron alone for the treatment of iron restrictive anemia (iron deficiency anemia and anemia of chronic inflammation) prior to unilateral total hip or knee arthroplasty surgery. Half of the study population will be randomly assigned to receive intravenous iron (Venofer; iron sucrose) and Eprex (subcutaneous epoetin alfa), while the other half will be randomized to receive Venofer (intravenous iron sucrose) and placebo (subcutaneous saline). This trial will be conducted in two phases. The vanguard phase will be conducted at a single site with a primary outcome of evaluating feasibility of the study. The full study phase will be conducted at four sites with a primary outcome of determining the impact of a combination treatment (intravenous iron plus erythropoietin) versus intravenous iron treatment alone on preoperative hemoglobin concentration. This study will also examine the RBC transfusion rate and clinical outcomes such as death, stroke, myocardial infarction, pulmonary embolism, infection, kidney injury, and deep vein thrombosis as secondary outcomes. Preoperatively, patients will be administered a total of 900mg of intravenous iron (Venofer, iron sucrose) over three visits (3-6 weeks before surgery). Then patients will be randomized to receive either two administrations of 40,000 IU of Erythropoietin (Eprex; Epoeitin alfa) or an identical placebo (saline) over two study visits (2-3 weeks before surgery). Study participants will be followed-up for 12 weeks after surgery. Study assessments and potential adverse events reporting will be undertaken at each study visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03528564
Study type	Interventional
Source	Unity Health Toronto
Contact
Status	Terminated
Phase	Phase 2
Start date	July 1, 2019
Completion date	May 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04058743` - Nickel Sensitivity	N/A
Completed	`NCT06321952` - Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA	N/A
Recruiting	`NCT06005623` - Motivational Feedback Following Total or Unicompartmental Knee Arthroplasty	N/A
Completed	`NCT06159205` - Core Stability Via Telerehabitation on TKA	N/A
Terminated	`NCT03665233` - Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty	N/A
Recruiting	`NCT04229368` - Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications	N/A
Withdrawn	`NCT03840122` - ACB + IPACK Block With or Without Local Infiltration in RA-TKA	N/A
Recruiting	`NCT05583630` - Ligament Tension Measurement in Knee Arthroplasty
Recruiting	`NCT06120023` - Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
Completed	`NCT05875324` - Effects of Virtual Reality in TKA Patients	N/A
Completed	`NCT03302832` - Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty	N/A
Completed	`NCT03230942` - Effect of Pre-op Patient Education on Functional Outcomes After TKA	N/A
Completed	`NCT03454256` - Virtual Reality Rehabilitation in Patients With Total Knee Replacement	N/A
Completed	`NCT05802368` - Hemophilic Knee Arthropathy Virtual Reality	N/A
Completed	`NCT05478005` - Function and Pain Following Knee Replacement	N/A
Recruiting	`NCT03495232` - Persona Cohort Nordic Multicenter Study
Completed	`NCT04183673` - Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery	N/A
Not yet recruiting	`NCT06337123` - Physica TT Tibial Plate Follow up Study
Completed	`NCT04883788` - The Impact of COVID-19 Pandemic on Hip and Knee Replacement
Active, not recruiting	`NCT04598568` - Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia — HOPE-Hb

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms