Sucrosomial Vs Intravenous Iron for Preoperative Anemia

Summary

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.

Timeline

Start

2026-12-01

Primary completion

2027-06-30

Completion

2027-06-30

Outcome

Outcome not reported

Stopped (Enrollment): “Study withdrawn due to lack of funding and the company's decision not to pursue the IND. No participants were enrolled.”

Publications

• Background 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.
• Background 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications