drugset / Trial / NCT06968936
Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy
Recruiting
400 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Chongqing Medical University · collabFirst Affiliated Hospital of Wenzhou Medical University · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe First Affiliated Hospital with Nanjing Medical University · collabZhejiang Provincial People's Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.
Timeline
- Start
- 2026-03-27
- Primary completion
- 2029-06-30
- Completion
- 2029-06-30
Publications
- Background Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.
- Background Fowler AJ, Ahmad T, Abbott TEF, Torrance HD, Wouters PF, De Hert S, Lobo SM, Rasmussen LS, Della Rocca G, Beattie WS, Wijeysundera DN, Pearse RM; International Surgical Outcomes Study Group. Association of preoperative anaemia with postoperative morbidity and mortality: an observational cohort study in low-, middle-, and high-income countries. Br J Anaesth. 2018 Dec;121(6):1227-1235. doi: 10.1016/j.bja.2018.08.026. Epub 2018 Oct 25.
- Background Carson JL, Brittenham GM. How I treat anemia with red blood cell transfusion and iron. Blood. 2023 Aug 31;142(9):777-785. doi: 10.1182/blood.2022018521.
- Background Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.
- Background Attallah N, Osman-Malik Y, Frinak S, Besarab A. Effect of intravenous ascorbic acid in hemodialysis patients with EPO-hyporesponsive anemia and hyperferritinemia. Am J Kidney Dis. 2006 Apr;47(4):644-54. doi: 10.1053/j.ajkd.2005.12.025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sucrose Iron | Unknown | 200 mg | Intravenous |
| Subject | Vitamin C | Other / unclassified | 2 g | Intravenous |
| Subject | epoetin alfa | Protein / enzyme biologic | 150 iu/kg | Subcutaneous |