Health TrialsbyHealthPanel

Sucrosomial Vs Intravenous Iron for Preoperative Anemia

ConditionsAnemiaIron Deficiency Anemia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of-care intravenous iron before surgery to see if the oral iron is as effective as intravenous iron in increasing the red blood cell count.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Coronary artery bypass graft surgery (CABG)

Valve procedures

Aortic root procedures

Disqualifiers

Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest

Undergoing heart transplantation or ventricular assist device placement

Lacking capacity to provide informed consent or unable to understand spoken and written English

Baseline hemoglobin >12 g/dL or <10 g/dL

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with oral sucrosomial iron

    Drug

    blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies

  • Treatment with intravenous iron

    Drug

    2 infusions of intravenous iron (ferumoxytol)

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: intravenous (IV) ironActive comparator 1 intervention
Group B: Sucrosomial IronExperimental treatment 1 intervention
Group C: 3rd arm is for data collection onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in hemoglobin from baseline to day of surgery or procedure

Change in hemoglobin in grams per deciliter from the baseline pre operative complete blood count to the complete blood count obtained on the day of surgery or procedure. Change will be calculated as hemoglobin on the day of surgery minus baseline hemoglobin.

Time frame
From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks

Secondary outcomes

1

Treatment compliance

Proportion of participants who complete the assigned iron treatment. Compliance is defined as receiving both infusions in the intravenous arm and taking the prescribed capsules in the oral arm, based on pill counts and participant reporting.

Time frame
From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
2

Proportion of participants receiving any blood transfusion

Number of participants who receive at least one transfusion of blood products after surgery or procedure

Time frame
From the end of surgery or procedure through thirty days post procedure
3

Change in iron study values from baseline to the day of surgery or procedure

Change in serum iron, ferritin, and transferrin saturation between baseline and day of surgery

Time frame
From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
4

Post operative complications

Number of participants who experience any of the following within thirty days: acute kidney injury, stroke, infection requiring antimicrobial therapy, or death.

Time frame
From the end of surgery or procedure through thirty days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Pharmanutra S.p.a.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: