Sucrosomiales vs. intravenöses Eisen bei präoperativer Anämie (RSIVI)
Randomisierte Studie zu Sucrosomialem Eisen versus intravenösem Eisen bei präoperativer Anämie (RSIVI)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Participants will be randomly assigned in a 1 to 1 ratio to one of two treatment groups. One group will receive intravenous (IV) iron, and the other group will receive oral sucrosomial iron.
Participants assigned to the IV iron group will receive two infusions at the University of Rochester Medical Center Center for Perioperative Medicine. Intravenous iron will be administered through a small plastic tube placed into a vein. Saline may be used to maintain the IV line as needed.
Participants assigned to the oral sucrosomial iron group will receive capsules to take at home until the date of surgery, with a dosage of two capsules per day.
All other aspects of perioperative care will follow standard practice. A blood sample for complete blood count and iron studies will be obtained on the day of surgery. This is typically collected when the IV is placed, so an additional needle stick is usually not required.
Randomization applies only to the two treatment arms (intravenous iron and oral sucrosomial iron). The third arm is a non randomized observational cohort for data collection only.
Studientyp
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
New York
-
Rochester, New York, Vereinigte Staaten, 14642
- University of Rochester
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age ≥18 years
- Scheduled for elective cardiac surgical procedures, including:
- Coronary artery bypass graft surgery (CABG)
- Valve procedures
- Aortic root procedures
- Transcatheter aortic valve implantation (TAVI)
- Hemoglobin <12 g/dL and ≥10 g/dL on a complete blood count obtained at the Center for Perioperative Medicine pre operative visit
- Evidence of iron deficiency
- Able to provide informed consent
- Able to understand spoken and written English
Exclusion Criteria:
- 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
- Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery
- History of hemoglobinopathy
- History of hematologic malignancy
- Bone marrow suppression from non nutritional causes
- Vitamin B12 or folate deficiency
- Known liver disease
- Known kidney disease
- Normal serum iron studies at baseline
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: intravenous (IV) iron
If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging. |
2 infusions of intravenous iron (ferumoxytol) |
|
Experimental: Sucrosomial Iron
If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day. |
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies |
|
Kein Eingriff: 3rd arm is for data collection only
In addition, 25 patients refusing randomization, but accepting data collection, will be treated as per the standard of care, but will have data collected as for the randomized groups with the exception of no CBC or iron studies will be performed on the day of surgery unless as part of routine care unrelated to study participation. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in hemoglobin from baseline to day of surgery or procedure
Zeitfenster: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
|
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. |
From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Treatment compliance
Zeitfenster: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
|
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. |
From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
|
|
Proportion of participants receiving any blood transfusion
Zeitfenster: From the end of surgery or procedure through thirty days post procedure
|
Number of participants who receive at least one transfusion of blood products after surgery or procedure |
From the end of surgery or procedure through thirty days post procedure
|
|
Change in iron study values from baseline to the day of surgery or procedure
Zeitfenster: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
|
Change in serum iron, ferritin, and transferrin saturation between baseline and day of surgery |
From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
|
|
Post operative complications
Zeitfenster: From the end of surgery or procedure through thirty days
|
Number of participants who experience any of the following within thirty days: acute kidney injury, stroke, infection requiring antimicrobial therapy, or death. |
From the end of surgery or procedure through thirty days
|
|
Length of intensive care unit stay
Zeitfenster: 30 days after hospital discharge
|
Duration of ICU stay in days, from ICU admission after surgery or procedure until ICU discharge. |
30 days after hospital discharge
|
|
Length of hospital stay
Zeitfenster: 30 days after hospital discharge
|
Duration of hospitalization in days, from admission for surgery or procedure until discharge |
30 days after hospital discharge
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Michael P Eaton, MD, University of Rochester
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
- Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Extra Corpor Technol. 2021 Jun;53(2):97-124. doi: 10.1182/ject-2100053. No abstract available.
- Padmanabhan H, Siau K, Curtis J, Ng A, Menon S, Luckraz H, Brookes MJ. Preoperative Anemia and Outcomes in Cardiovascular Surgery: Systematic Review and Meta-Analysis. Ann Thorac Surg. 2019 Dec;108(6):1840-1848. doi: 10.1016/j.athoracsur.2019.04.108. Epub 2019 Jun 21.
- Bertani L, Trico D, Zanzi F, Baiano Svizzero G, Coppini F, de Bortoli N, Bellini M, Antonioli L, Blandizzi C, Marchi S. Oral Sucrosomial Iron Is as Effective as Intravenous Ferric Carboxy-Maltose in Treating Anemia in Patients with Ulcerative Colitis. Nutrients. 2021 Feb 12;13(2):608. doi: 10.3390/nu13020608.
- Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
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Studienabschluss (Geschätzt)
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Zuerst gepostet (Tatsächlich)
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Letztes eingereichtes Update, das die QC-Kriterien erfüllt
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Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00011152
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