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Anemia, Iron DeficiencyPhase 2HOPE-HbNCT03528564

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

A Phase 2 study testing Iron sucrose and Epoetin Alfa in people with Anemia, Iron Deficiency and Anemia of Chronic Disease, run by Unity Health Toronto at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Iron sucrose and Epoetin Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteCanada
Study dates
1 Jul 2019to 31 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hosptial

    Toronto, Ontario, M5B1W8

Other trials in Canada

About this study

Official title: A Randomized Double-Blinded Phase II Study to Determine Treatment Protocol for Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia

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.

Read the detailed 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.

Being tested
Iron sucrose, Epoetin Alfa, Placebo
Keywords
Preoperative Anemia, Intravenous Iron, Erythropoietin
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iron sucroseDrug

    Also called Venofer

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

  • Epoetin AlfaDrug

    Also called Eprex

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

  • PlaceboDrug

    Also called Saline

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

Study groups in NCT03528564
Study groupRoleWhat they receive
Epoetin alfaExperimentalPreoperative treatment of anemia with iron sucrose (Venofer) plus Epoetin Alfa (Eprex)
Receives: Drug: Iron sucrose; Drug: Epoetin Alfa
Intravenous IronPlacebo comparatorPreoperative treatment of anemia with iron sucrose (Venofer) plus placebo (saline)
Receives: Drug: Iron sucrose; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: 18 weeks from randomization

  2. 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.

    Measured: 6 weeks from randomization

Secondary outcomes (18)

  1. Post-Treatment Hemoglobin Concentration

    Change in post-treatment hemoglobin concentration from baseline

    Measured: 12 weeks from randomization

  2. Change in Hemoglobin Concentration from Initiation of Treatment

    Rate of hemoglobin change from initiation of treatment to final preoperative hemoglobin

    Measured: 6 weeks from randomization

  3. Postoperative Hemoglobin Concentration

    Hemoglobin concentration on postoperative day 2 (prior to hospital discharge); and 4-6 weeks after surgery

    Measured: 0 weeks from surgery and 12 weeks from surgery

  4. Red Blood Cell Transfusions

    Rate of RBC transfusion and number of units transfused during surgery and up to 6 weeks postoperatively

    Measured: 6 weeks from surgery

  5. Deep Vein Thrombosis

    Incidence of DVT up to 12 weeks postoperatively

    Measured: 12 weeks from surgery

  6. Composite of Morbidity

    Incidence of a composite clinical outcome including death, stroke, myocardial infarction, pulmonary embolism, infection, acute kidney injury, and deep vein thrombosis from treatment to up to 3 months post surgery

    Measured: 3 months from surgery

  7. Surgical Wound Infection

    Incidence of superficial and deep wound infection from treatment to 4-6 weeks post surgery

    Measured: 6 weeks from surgery

  8. Assessment of Iron Status

    Hematological outcomes for treatment efficacy including: Hb, ferritin, hepcidin, and transferrin saturation (TSAT) pre-operatively and 4-6 weeks postoperatively

    Measured: 6 weeks from surgery

  9. Digit Span Test

    Cognitive assessment of memory span

    Measured: 6 weeks from surgery

  10. California Verbal Learning Test

    Cognitive assessment of word learning, recall and recognition, as well as episodic memory

    Measured: 6 weeks from surgery

  11. Neuropsychological Impairment Scale

    A subjective cognitive assessment of cognitive functioning. This is a 95-item questionnaire, with all items rated on a scale from 0 (not at all) to 5 (extremely). From the 95 total items, 80 items describe neurophysiological symptoms (Global measure of impairment; GMI), 10 items describe affective disturbance, and 5 items assess test-taking attitudes. A total GMI score can range from 0-320, with higher scores indicating an increased impairment index.

    Measured: 6 weeks from surgery

  12. Trail Making Test

    Cognitive assessment of processing speed

    Measured: 6 weeks from surgery

  13. Digit Symbol

    Cognitive assessment of response speed, sustained attention, and visual spatial skills

    Measured: 6 weeks from surgery

  14. Montreal Cognitive Assessment

    Cognitive assessment of global cognitive functioning

    Measured: 6 weeks from surgery

  15. Stroop Colour and Word Test

    Cognitive assessment of processing speed

    Measured: 6 weeks from surgery

  16. Wisconsin Card Sorting Test

    Cognitive assessment of a participant's ability to set-shift (display flexibility in the face of changing conditions)

    Measured: 6 weeks from surgery

  17. Hospital Anxiety and Depression Scale

    Cognitive assessment of anxiety and depression levels. A total score between 0-7 indicates normal levels of depression or anxiety; a total score between 8-10 indicates borderline abnormal levels of anxiety or depression; and a total score between 11-21 indicates abnormal levels of depression or anxiety

    Measured: 6 weeks from surgery

  18. Cost Analysis

    Assessment of relative cost of treatment and cost savings associated with transfusion avoidance will be assessed (see projected cost analysis; appended)

    Measured: 12 weeks from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start1 Jul 2019
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

Why it stopped: The primary reasoning is that we were unable to demonstrate feasibility, prior to and because of the impact of COVID on our research programs.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03528564
Sponsor's protocol ID
HOPE-Hb
Acronym
HOPE-Hb
Status last verified
Jun 2021
First submitted
9 Apr 2018
Last updated
18 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iron sucrose and Epoetin Alfa in people with Anemia, Iron Deficiency and Anemia of Chronic Disease, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The primary reasoning is that we were unable to demonstrate feasibility, prior to and because of the impact of COVID on our research programs.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vanguard Phase (Initial 12 patients): Feasibility of using Erythropoietin + Intravenous Iron to Treat Preoperative Iron Restrictive Anemia (time frame: 18 weeks from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03528564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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