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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Iron Supplementation Group | Experimental | Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds |
|
| Conventional treatment group | Active Comparator | Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose Iron,subcutaneous recombinant human erythropoietin,intravenous vitamin C | Drug | Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EQ-5D) | Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire | 1 year postoperatively (±30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) | Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI) | 1 year postoperatively (±30 days) |
| Fatigue (FACIT-Fatigue Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Gao, Dr. | Contact | 19857136919 | gaoqi19950203@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 330100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33475735 | 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. | |
| 30442249 | 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. |
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| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
Central stratified block group randomization
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Blinding was maintained for outcome assessors, extracorporeal circulation staff, and all investigators not directly involved in the treatment process.
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| Routine perioperative management | Procedure | Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices. |
|
Measurement of fatigue level using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
| 1 year postoperatively (±30 days) |
| All-cause Complications | Occurrence of any postoperative complications from any cause during the 1-year follow-up period | Up to 1 year postoperatively |
| Hospital Readmission | Any hospital readmission for any cause within 1 year after surgery. | Up to 1 year postoperatively |
| Repeat Cardiac Surgery | Any subsequent cardiac surgery (reoperation) within 1 year after the index surgery. | Up to 1 year postoperatively |
| All-cause Mortality | Death from any cause within 1 year after surgery. | Up to 1 year postoperatively |
| 36315909 | 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. |
| 31036337 | 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. |
| 16564942 | 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. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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