Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)
NCT ID: NCT04083755
Last Updated: 2023-01-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
240 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-08-15
Study Completion Date
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Introduction: Anaemia due to iron and vitamin deficiency among patients with critical limb ischemia is high (\>50%). The prevalence of a higher rate of anaemia extends into the three months prior to revascularization surgery, it is associated with longer hospital stays and more transfusions in addition to being a factor in poor prognoses. Study and treatment of anaemia within the perioperative period could improve the surgical outcomes, including the recovery and the quality of patients' lives. There are several types of intravenous iron preparations with different administration protocols, but there is not a consensus on the timing and type of the appropriate iron therapy. To the best of our knowledge, there is no data on the performance of intravenous iron in the management of preoperative anaemia in patients with peripheral artery disease (PAD) in vascular surgery.
Methods and analysis: The IRONPAD Study is a phase IV randomised controlled trial with two branches of treatment on the efficacy of intravenous iron therapy for the optimisation of blood use and prognosis in the perioperative period of patients with anaemia undergoing revascularisation for chronic lower limb ischemia. The study randomises 240 patients with anaemia to: treat with a single intravenous dose of ferric carboxymaltose (1000 mg) or no treatment vs oral iron supplements (if severe anaemia) a minimum of two days prior to lower limb revascularisation surgery. The primary outcome is to reduce the incidence of transfusion from randomisation up to 30+7 days after the main surgery. The secondary outcomes will be included to establish the optimal preoperative moment of increased intravenous iron administration, to raise haemoglobin levels; to study the evolution of haemoglobin from inclusion to 30+7 days after surgery; and to determine the impact of anaemia and its treatment on the length of hospital stay, morbidity and mortality, as well as the quality of life in this period.
Methods and analysis: The IRONPAD Study is a phase IV randomised controlled trial with two branches of treatment on the efficacy of intravenous iron therapy for the optimisation of blood use and prognosis in the perioperative period of patients with anaemia undergoing revascularisation for chronic lower limb ischemia. The study randomises 240 patients with anaemia to: treat with a single intravenous dose of ferric carboxymaltose (1000 mg) or no treatment vs oral iron supplements (if severe anaemia) a minimum of two days prior to lower limb revascularisation surgery. The primary outcome is to reduce the incidence of transfusion from randomisation up to 30+7 days after the main surgery. The secondary outcomes will be included to establish the optimal preoperative moment of increased intravenous iron administration, to raise haemoglobin levels; to study the evolution of haemoglobin from inclusion to 30+7 days after surgery; and to determine the impact of anaemia and its treatment on the length of hospital stay, morbidity and mortality, as well as the quality of life in this period.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients
NCT04087993
Iron Deficiency Anemia
WITHDRAWN
PHASE3
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality
NCT03036462
Systolic Heart Failure
Iron Deficiency
COMPLETED
PHASE4
Impact of Intravenous Iron on Musculoskeletal Function in Older Adults
NCT05708170
Iron Deficiency Anemia
NOT_YET_RECRUITING
PHASE4
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
NCT02031289
Anemia
Iron Deficiency
COMPLETED
PHASE4
Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis
NCT04206228
Severe Aortic Stenosis
Iron-deficiency
UNKNOWN
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The IRONPAD Study is a phase IV randomised controlled trial with two branches of treatment on the efficacy of intravenous iron therapy for the optimisation of blood use and prognosis in the perioperative period of patients with anaemia undergoing revascularisation for chronic lower limb ischemia.
Patients admitted to hospital with anaemia and indication of elective revascularisation surgery for chronic ischemia of the lower limbs will be eligible for screening. Anaemia in this study is established following the WHO criteria with haemoglobin (Hb) \<130 g/L in men and \<120 g/L in women 21.
Patients will be selected according to the usual practice, without excluding patients because of comorbidity or other reasons that may affect results (selection bias).
Prior to inclusion, freely given written informed consent will be obtained from all patients. Once included, each patient will be masked into a unique identity number (correlative according to inclusion), as a reference of patient ID in the registry.
Each patient will be randomised to a line A or line B of treatment.
* Line A: a single, ferric carboxymaltose (Ferinject®) 1000 mg IV iron dose administration. The infusion will be according to product specifications with an approximate duration of 15 minutes during hospitalisation and will not require an additional site visit or extended period of hospitalisation.
* Line B: control. The control group will not receive specific treatment. In case of severe iron deficiency anaemia, oral iron supplements (iron sulphate dihydrate) will be given.
Both lines may be followed in addition to taking vitamin B12 and folic acid, if indicated.
The patient, once included in the study, may receive a blood transfusion if the following criteria are met:
\- Absolute indication: Hemodynamic instability Active bleeding Hb \<7 g/dl
\- Relative indications: in case of Hb \<8.5 g/dL or haematocrit \<28% following the clinical criteria of the medical specialist.
Interventions to be measured:
The data collected at baseline will include patients' past medical history, medications, blood tests (including hemogram, iron tests and renal function), comorbidity index (Charlson Scale), lower limbs chronic ischemia category and the limb scheduled for revascularisation (including registry of any trophic lesions and if they have signs of active infection), height, weight and body-mass index of the patient. In addition, already validated quality of life questionnaire, the Short Form-36 Health Survey (SF-36) will be completed.
Procedure data will record: date of IV iron treatment, if received, dose and any adverse events during or after administration; ASA (American Society of Anaesthesiologists) risk level; type of surgery performed for revascularisation of lower limbs, information on clinical success and complications of the intervention. Blood records will include haemoglobin before and first day after surgery and number of red blood cell units of or any other blood component transfused during the surgical procedure. If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat.
The hospital discharge visit will record: date of discharge; last hemogram; number of blood transfusions from the postoperative period until discharge; days in intensive care; adverse events such as medical and surgical complications as well as mortality.
The final follow-up visit will take place 30 days after the main surgery (with + 7 day window) it would be performed by telephone, in the outpatient consultation or in the hospital if the patient continues to be hospitalised; in that case, the discharge visit and final visit will be made simultaneously. It will record: blood tests (including hemogram, iron tests), clinical success, serious adverse events (SAE) and mortality, which may have occurred between hospital discharge and the visit in addition to Short Form-36 Health Survey (SF-36). See Fig. 1 for Assessment flow diagram.
Patients admitted to hospital with anaemia and indication of elective revascularisation surgery for chronic ischemia of the lower limbs will be eligible for screening. Anaemia in this study is established following the WHO criteria with haemoglobin (Hb) \<130 g/L in men and \<120 g/L in women 21.
Patients will be selected according to the usual practice, without excluding patients because of comorbidity or other reasons that may affect results (selection bias).
Prior to inclusion, freely given written informed consent will be obtained from all patients. Once included, each patient will be masked into a unique identity number (correlative according to inclusion), as a reference of patient ID in the registry.
Each patient will be randomised to a line A or line B of treatment.
* Line A: a single, ferric carboxymaltose (Ferinject®) 1000 mg IV iron dose administration. The infusion will be according to product specifications with an approximate duration of 15 minutes during hospitalisation and will not require an additional site visit or extended period of hospitalisation.
* Line B: control. The control group will not receive specific treatment. In case of severe iron deficiency anaemia, oral iron supplements (iron sulphate dihydrate) will be given.
Both lines may be followed in addition to taking vitamin B12 and folic acid, if indicated.
The patient, once included in the study, may receive a blood transfusion if the following criteria are met:
\- Absolute indication: Hemodynamic instability Active bleeding Hb \<7 g/dl
\- Relative indications: in case of Hb \<8.5 g/dL or haematocrit \<28% following the clinical criteria of the medical specialist.
Interventions to be measured:
The data collected at baseline will include patients' past medical history, medications, blood tests (including hemogram, iron tests and renal function), comorbidity index (Charlson Scale), lower limbs chronic ischemia category and the limb scheduled for revascularisation (including registry of any trophic lesions and if they have signs of active infection), height, weight and body-mass index of the patient. In addition, already validated quality of life questionnaire, the Short Form-36 Health Survey (SF-36) will be completed.
Procedure data will record: date of IV iron treatment, if received, dose and any adverse events during or after administration; ASA (American Society of Anaesthesiologists) risk level; type of surgery performed for revascularisation of lower limbs, information on clinical success and complications of the intervention. Blood records will include haemoglobin before and first day after surgery and number of red blood cell units of or any other blood component transfused during the surgical procedure. If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat.
The hospital discharge visit will record: date of discharge; last hemogram; number of blood transfusions from the postoperative period until discharge; days in intensive care; adverse events such as medical and surgical complications as well as mortality.
The final follow-up visit will take place 30 days after the main surgery (with + 7 day window) it would be performed by telephone, in the outpatient consultation or in the hospital if the patient continues to be hospitalised; in that case, the discharge visit and final visit will be made simultaneously. It will record: blood tests (including hemogram, iron tests), clinical success, serious adverse events (SAE) and mortality, which may have occurred between hospital discharge and the visit in addition to Short Form-36 Health Survey (SF-36). See Fig. 1 for Assessment flow diagram.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Anemia
Peripheral Arterial Occlusive Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Line A
One dose of Ferric carboxymaltose (1000mg) intravenous. Duration of administration 15 minutes.
Group Type
ACTIVE_COMPARATOR
Ferric Carboxymaltose Injection [Injectafer]
Intervention Type
DRUG
1000mg intravenous
Line B
No treatment or treatment oral with iron supplementation if iron-deficiency anemia
Group Type
OTHER
no treatment or oral iron supplementation
Intervention Type
OTHER
No treatment or treatment oral with iron supplementation if iron-deficiency anemia
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ferric Carboxymaltose Injection [Injectafer]
1000mg intravenous
Intervention Type
DRUG
no treatment or oral iron supplementation
No treatment or treatment oral with iron supplementation if iron-deficiency anemia
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Ferinject
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients of both sexes over 18 years
* Patients diagnosed with anemia, considered as Hb \<13.0 g/dL in mens and Hb\<12g/dL in women
* Patients diagnosed with symptomatic chronic lower limb ischemia (degrees 2-5 by Rutherford-Baker, both included, Fontaine II-IV), who will undergo surgical revascularization (endovascular or open) and accept treatment
* Revascularization surgery scheduled in the approximate minimum period of two days, (\> 48 hours) from the inclusion, Patients diagnosed with iron deficiency anemia being treated with oral iron in their usual medication and with inadequate iron storage for surgical intervention (ferritin \<100 ng/ml) or functional iron deficiency: ferritin 100-500 ng/ml with TSI \< 20% .
* They are able and willing to give written informed consent at the time of selection
* Patients diagnosed with anemia, considered as Hb \<13.0 g/dL in mens and Hb\<12g/dL in women
* Patients diagnosed with symptomatic chronic lower limb ischemia (degrees 2-5 by Rutherford-Baker, both included, Fontaine II-IV), who will undergo surgical revascularization (endovascular or open) and accept treatment
* Revascularization surgery scheduled in the approximate minimum period of two days, (\> 48 hours) from the inclusion, Patients diagnosed with iron deficiency anemia being treated with oral iron in their usual medication and with inadequate iron storage for surgical intervention (ferritin \<100 ng/ml) or functional iron deficiency: ferritin 100-500 ng/ml with TSI \< 20% .
* They are able and willing to give written informed consent at the time of selection
Exclusion Criteria
* Patients with acute ischemia will be excluded
* Severe anemia \< 8 gr/dL
* Arterial hypertension not controlled with antihypertensive medication (considered with systolic blood pressure\> 180mmHg or diastolic\> 100mmHg)
* Acute renal failure or renal failure with creatinine clearance \<30mmHg
* Patient with documented intolerance or allergy to iron or its derivatives
* Unstable angina, defined as electrocardiographic changes with chest pain that indicate resting myocardial ischemia
* History of stroke in the previous 6 months
* Patients with thrombocytopenia less than 50,000ug/dl or alterations in coagulation
* That you are simultaneously participating in a clinical trial that conditions or modifies the registry
* Pregnancy or lactation (pregnancy tests in women of childbearing age according to usual practice)
* Rejection of treatment or inclusion in the registry by the patient
* Patients who refuse to receive transfusions of blood products (for example, Jehovah's Witnesses)
* Patients with criteria of SEPSIS
* Patients with Ferritin \<30 ng/ml that will be directed for digestive study
* Patients with active neoplasia
* Probable or confirmed case with active SARS-CoV-2 infection
* Patients who are not able to give their informed consent or understand the study procedure
* Severe anemia \< 8 gr/dL
* Arterial hypertension not controlled with antihypertensive medication (considered with systolic blood pressure\> 180mmHg or diastolic\> 100mmHg)
* Acute renal failure or renal failure with creatinine clearance \<30mmHg
* Patient with documented intolerance or allergy to iron or its derivatives
* Unstable angina, defined as electrocardiographic changes with chest pain that indicate resting myocardial ischemia
* History of stroke in the previous 6 months
* Patients with thrombocytopenia less than 50,000ug/dl or alterations in coagulation
* That you are simultaneously participating in a clinical trial that conditions or modifies the registry
* Pregnancy or lactation (pregnancy tests in women of childbearing age according to usual practice)
* Rejection of treatment or inclusion in the registry by the patient
* Patients who refuse to receive transfusions of blood products (for example, Jehovah's Witnesses)
* Patients with criteria of SEPSIS
* Patients with Ferritin \<30 ng/ml that will be directed for digestive study
* Patients with active neoplasia
* Probable or confirmed case with active SARS-CoV-2 infection
* Patients who are not able to give their informed consent or understand the study procedure
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sociedad Espanola de Angiologia y Cirugia Vascular
NETWORK
Sponsor Role
collaborator
Biocruces Bizkaia Health Research Institute
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ana Apodaka Diez
Vascular Surgeon
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ana Apodaka Diez, MD
Role: PRINCIPAL_INVESTIGATOR
Vascular Surgeon
Jose Manuel Rodriguez Chinesta, MD
Role: PRINCIPAL_INVESTIGATOR
Internal Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Galdakao-Usansolo.
Galdakao, Basque Country, Spain
Site Status
RECRUITING
Servicio de Angiología y Cirugía vascular del Hospital Universitario Cruces
Barakaldo, Biscay, Spain
Site Status
RECRUITING
Hospital de Getafe
Getafe, Madrid, Spain
Site Status
NOT_YET_RECRUITING
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario La Paz
Madrid, , Spain
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Spain
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ana Apodaka, MD
Role: primary
34610471636
Maria Azucena Ayala Strub
Role: primary
Alvaro Fernandez Heredero
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Esteban Gracia C, Escudero Rodríguez JR, Preciado Mora MJ, et al. Prevalencia de anemia en pacientes sometidos a cirugía vascular electiva y su influencia en el postoperatorio. Angiologia 2016;68:396-404. doi:10.1016/j.angio.2016.01.015
Reference Type
BACKGROUND
Vega de Ceniga M, Bravo E, Izagirre M, Casco C, Estallo L, Esteban M, Barba A. Anaemia, iron and vitamin deficits in patients with peripheral arterial disease. Eur J Vasc Endovasc Surg. 2011 Jun;41(6):828-30. doi: 10.1016/j.ejvs.2011.01.017. Epub 2011 Feb 25.
Reference Type
BACKGROUND
Gonzalez ZM, Barrasa AG, Renau AR. [Anaemia, iron, transfusion and therapeutic alternatives. A review from a surgical perspective]. Cir Esp. 2010 Dec;88(6):358-68. doi: 10.1016/j.ciresp.2010.03.014. Epub 2010 May 11. Spanish.
Reference Type
BACKGROUND
Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.
Reference Type
BACKGROUND
Munoz M, Gomez-Ramirez S, Martin-Montanez E, Pavia J, Cuenca J, Garcia-Erce JA. Perioperative intravenous iron: an upfront therapy for treating anaemia and reducing transfusion requirements. Nutr Hosp. 2012 Nov-Dec;27(6):1817-36. doi: 10.3305/nh.2012.27.6.6087.
Reference Type
BACKGROUND
Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, Pearse RM, Metnitz P; European Surgical Outcomes Study (EuSOS) group for Trials Groups of European Society of Intensive Care Medicine; European Society of Anaesthesiology. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014 Sep;113(3):416-23. doi: 10.1093/bja/aeu098. Epub 2014 May 14.
Reference Type
BACKGROUND
Fowler AJ, Ahmad T, Phull MK, Allard S, Gillies MA, Pearse RM. Meta-analysis of the association between preoperative anaemia and mortality after surgery. Br J Surg. 2015 Oct;102(11):1314-24. doi: 10.1002/bjs.9861.
Reference Type
BACKGROUND
Glance LG, Dick AW, Mukamel DB, Fleming FJ, Zollo RA, Wissler R, Salloum R, Meredith UW, Osler TM. Association between intraoperative blood transfusion and mortality and morbidity in patients undergoing noncardiac surgery. Anesthesiology. 2011 Feb;114(2):283-92. doi: 10.1097/ALN.0b013e3182054d06.
Reference Type
BACKGROUND
Zollo RA, Eaton MP, Karcz M, Pasternak R, Glance LG. Blood transfusion in the perioperative period. Best Pract Res Clin Anaesthesiol. 2012 Dec;26(4):475-84. doi: 10.1016/j.bpa.2012.10.001.
Reference Type
BACKGROUND
Kougias P, Orcutt S, Pak T, Pisimisis G, Barshes NR, Lin PH, Bechara CF. Impact of postoperative nadir hemoglobin and blood transfusion on outcomes after operations for atherosclerotic vascular disease. J Vasc Surg. 2013 May;57(5):1331-7; discussion. doi: 10.1016/j.jvs.2012.10.108. Epub 2013 Feb 4.
Reference Type
BACKGROUND
Dunkelgrun M, Hoeks SE, Welten GM, Vidakovic R, Winkel TA, Schouten O, van Domburg RT, Bax JJ, Kuijper R, Chonchol M, Verhagen HJ, Poldermans D. Anemia as an independent predictor of perioperative and long-term cardiovascular outcome in patients scheduled for elective vascular surgery. Am J Cardiol. 2008 Apr 15;101(8):1196-200. doi: 10.1016/j.amjcard.2007.11.072. Epub 2008 Feb 7.
Reference Type
BACKGROUND
Desormais I, Aboyans V, Bura A, Constans J, Cambou JP, Messas E, Labrunie A, Lacroix P. Anemia, an independent predictive factor for amputation and mortality in patients hospitalized for peripheral artery disease. Eur J Vasc Endovasc Surg. 2014 Aug;48(2):202-7. doi: 10.1016/j.ejvs.2014.04.005. Epub 2014 Jun 14.
Reference Type
BACKGROUND
Toor IS, Jaumdally RJ, Moss MS, Babu SB. Preprocedural hemoglobin predicts outcome in peripheral vascular disease patients undergoing percutaneous transluminal angioplasty. J Vasc Surg. 2009 Aug;50(2):317-21. doi: 10.1016/j.jvs.2009.03.041.
Reference Type
BACKGROUND
Preciado Mora MJ, Azparren Cabezón G, Escudero Rodríguez JR, et al. La anemia como factor de riesgo quirúrgico en cirugía vascular. Algoritmos de diagnóstico y tratamiento. Angiologia 2017;69:242-9. doi:10.1016/j.angio.2016.08.007
Reference Type
BACKGROUND
Kumar A. Perioperative management of anemia: limits of blood transfusion and alternatives to it. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S112-8. doi: 10.3949/ccjm.76.s4.18.
Reference Type
BACKGROUND
Cuenca J, Garcia-Erce JA, Martinez AA, Solano VM, Molina J, Munoz M. Role of parenteral iron in the management of anaemia in the elderly patient undergoing displaced subcapital hip fracture repair: preliminary data. Arch Orthop Trauma Surg. 2005 Jun;125(5):342-7. doi: 10.1007/s00402-005-0809-3. Epub 2005 Mar 24.
Reference Type
BACKGROUND
Serrano-Trenas JA, Ugalde PF, Cabello LM, Chofles LC, Lazaro PS, Benitez PC. Role of perioperative intravenous iron therapy in elderly hip fracture patients: a single-center randomized controlled trial. Transfusion. 2011 Jan;51(1):97-104. doi: 10.1111/j.1537-2995.2010.02769.x.
Reference Type
BACKGROUND
Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.
Reference Type
BACKGROUND
Hallet J, Hanif A, Callum J, Pronina I, Wallace D, Yohanathan L, McLeod R, Coburn N. The impact of perioperative iron on the use of red blood cell transfusions in gastrointestinal surgery: a systematic review and meta-analysis. Transfus Med Rev. 2014 Oct;28(4):205-11. doi: 10.1016/j.tmrv.2014.05.004. Epub 2014 Jun 3.
Reference Type
BACKGROUND
Ng O, Keeler BD, Mishra A, Simpson A, Neal K, Brookes MJ, Acheson AG. Iron therapy for pre-operative anaemia. Cochrane Database Syst Rev. 2015 Dec 22;(12):CD011588. doi: 10.1002/14651858.CD011588.pub2.
Reference Type
BACKGROUND
Nutritional anaemias. Report of a WHO scientific group. World Health Organ Tech Rep Ser. 1968;405:5-37. No abstract available.
Reference Type
BACKGROUND
Esteban C, Rodriguez P, Escudero JR, Clara A, Fernandez A, Fernandez S, Agundez I. Anaemia in patients who underwent vascular surgery: a significant predictor of amputation and death. Med Clin (Barc). 2019 Jan 4;152(1):6-12. doi: 10.1016/j.medcli.2018.01.029. Epub 2018 Apr 9. English, Spanish.
Reference Type
BACKGROUND
Munoz M, Gomez-Ramirez S, Besser M, Pavia J, Gomollon F, Liumbruno GM, Bhandari S, Cladellas M, Shander A, Auerbach M. Current misconceptions in diagnosis and management of iron deficiency. Blood Transfus. 2017 Sep;15(5):422-437. doi: 10.2450/2017.0113-17.
Reference Type
BACKGROUND
Dignass AU, Gasche C, Bettenworth D, Birgegard G, Danese S, Gisbert JP, Gomollon F, Iqbal T, Katsanos K, Koutroubakis I, Magro F, Savoye G, Stein J, Vavricka S; European Crohn's and Colitis Organisation [ECCO]. European consensus on the diagnosis and management of iron deficiency and anaemia in inflammatory bowel diseases. J Crohns Colitis. 2015 Mar;9(3):211-22. doi: 10.1093/ecco-jcc/jju009. Epub 2014 Dec 3. No abstract available.
Reference Type
BACKGROUND
Goodnough LT, Shander A, Spivak JL, Waters JH, Friedman AJ, Carson JL, Keating EM, Maddox T, Spence R. Detection, evaluation, and management of anemia in the elective surgical patient. Anesth Analg. 2005 Dec;101(6):1858-1861. doi: 10.1213/01.ANE.0000184124.29397.EB.
Reference Type
BACKGROUND
Kotze A, Harris A, Baker C, Iqbal T, Lavies N, Richards T, Ryan K, Taylor C, Thomas D. British Committee for Standards in Haematology Guidelines on the Identification and Management of Pre-Operative Anaemia. Br J Haematol. 2015 Nov;171(3):322-31. doi: 10.1111/bjh.13623. Epub 2015 Sep 6. No abstract available.
Reference Type
BACKGROUND
Edwards TJ, Noble EJ, Durran A, Mellor N, Hosie KB. Randomized clinical trial of preoperative intravenous iron sucrose to reduce blood transfusion in anaemic patients after colorectal cancer surgery. Br J Surg. 2009 Oct;96(10):1122-8. doi: 10.1002/bjs.6688.
Reference Type
BACKGROUND
Kim YH, Chung HH, Kang SB, Kim SC, Kim YT. Safety and usefulness of intravenous iron sucrose in the management of preoperative anemia in patients with menorrhagia: a phase IV, open-label, prospective, randomized study. Acta Haematol. 2009;121(1):37-41. doi: 10.1159/000210062. Epub 2009 Mar 31.
Reference Type
BACKGROUND
Rognoni C, Venturini S, Meregaglia M, Marmifero M, Tarricone R. Efficacy and Safety of Ferric Carboxymaltose and Other Formulations in Iron-Deficient Patients: A Systematic Review and Network Meta-analysis of Randomised Controlled Trials. Clin Drug Investig. 2016 Mar;36(3):177-94. doi: 10.1007/s40261-015-0361-z.
Reference Type
BACKGROUND
Friedrisch JR, Cancado RD. Intravenous ferric carboxymaltose for the treatment of iron deficiency anemia. Rev Bras Hematol Hemoter. 2015 Nov-Dec;37(6):400-5. doi: 10.1016/j.bjhh.2015.08.012. Epub 2015 Oct 14.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-003714-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2018-003714-40
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
NCT01394562
COMPLETED
PHASE3
Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
NCT03037931
COMPLETED
PHASE3
IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients
NCT01447628
COMPLETED
PHASE2
Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction
NCT03074591
COMPLETED
PHASE4
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
NCT06542822
RECRUITING
Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women
NCT01374776
COMPLETED
PHASE4
A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer
NCT02905539
COMPLETED
PHASE4
IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
NCT02541708
UNKNOWN
PHASE3
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
NCT02731534
COMPLETED
PHASE3
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
NCT01245777
COMPLETED
PHASE4
Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
NCT02826681
TERMINATED
PHASE2
Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial
NCT05358509
COMPLETED
PHASE4
IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department
NCT05153278
COMPLETED
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
NCT00982007
COMPLETED
PHASE3
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
NCT04318405
COMPLETED
Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
NCT02642562
COMPLETED
PHASE4
Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion
NCT04061655
COMPLETED
EARLY_PHASE1
Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron.
NCT02392910
COMPLETED
PHASE4
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
NCT02937454
COMPLETED
PHASE4
Oral Iron Therapy in Chronic Heart Failure Patients
NCT02698046
UNKNOWN
PHASE3
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
NCT03218384
TERMINATED
PHASE2
Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman
NCT05950841
COMPLETED
PHASE3
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
NCT01984554
COMPLETED
Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
NCT01380548
COMPLETED
NA