AnemiaPhase 4IRONPADNCT04083755
Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)
A Phase 4 study testing Ferric Carboxymaltose Injection [Injectafer] and no treatment or oral iron supplementation in people with Anemia and Peripheral Arterial Occlusive Disease, run by Biobizkaia Health Research Institute at 5 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Peripheral Arterial Occlusive Disease
- What is being tested?
- Ferric Carboxymaltose Injection [Injectafer] and no treatment or oral iron supplementation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesSpain
- Study dates
- 15 Aug 2019to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Servicio de Angiología y Cirugía vascular del Hospital Universitario Cruces
Barakaldo, Biscay, 48903
Ana Apodaka, MD, 34610471636
- Recruiting
Hospital de Galdakao-Usansolo.
Galdakao, Basque Country, 48960
Melina Vega, melinavega@hotmail.com
Melina Vega
- Not yet recruiting
Hospital de Getafe
Getafe, Madrid
Jose Ramon March García, jrmarchg@gmail.com
Jose Ramon March García
- Not yet recruiting
Hospital General Universitario Gregorio Marañon
Madrid
Maria Azucena Ayala Strub
- Recruiting
Hospital Universitario La Paz
Madrid
Alvaro Fernandez Heredero
Alvaro Fernandez Heredero
About this study
Official title: Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With Lower Extremity Peripheral Artery Disease
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.
Read the detailed description
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.
- Conditions
- Anemia, Peripheral Arterial Occlusive Disease
- Being tested
- Ferric Carboxymaltose Injection [Injectafer], no treatment or oral iron supplementation
- Keywords
- anemia, iron, surgery, PAD
- Medical subject headings
- Anemia, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose Injection [Injectafer]Drug
Also called Ferinject
1000mg intravenous
no treatment or oral iron supplementationOther
No treatment or treatment oral with iron supplementation if iron-deficiency anemia
| Study group | Role | What they receive |
|---|---|---|
| Line A | Active comparator | One dose of Ferric carboxymaltose (1000mg) intravenous. Duration of administration 15 minutes. Receives: Drug: Ferric Carboxymaltose Injection [Injectafer] |
| Line B | Other | No treatment or treatment oral with iron supplementation if iron-deficiency anemia Receives: Other: no treatment or oral iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reduce the incidence of transfusion (receiving any volume of 1 unit or more than 1 unit of packed red cells) from randomisation up to 30 days (with +/- 15-day window) after the main surgery
Number of red blood cell units of or any other blood component transfused during the surgical procedure and from the postoperative period until discharge. If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat.
Measured: From inclusion date to 30 days (with +7 window) after the main surgery
Secondary outcomes (6)
Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge.
The data collected at baseline will include patients blood tests (including hemogram). Blood records during surgical period will include haemoglobin (g/dL) before and first day after surgery. (If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat).The final follow-up visit will take place 30 days after the main surgery 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).
Measured: From inclusion date to 30 days (with +7day window) after surgical procedure
Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb
Best time before surgery for treatment anemia with ferric carboxymaltose
Measured: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on the length of hospital stay
Difference between both groups in days of hospitalization after main surgery
Measured: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on morbidity
Serious adverse events such, as medical and surgical complications during hospitalization and at final follow-up visit (which may have occurred between hospital discharge and final the visit).
Measured: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on mortality
Death and cause, if known, during hospitalization and at the final follow-up visit (which may have occurred between hospital discharge and final the visit).
Measured: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on quality of life
The Short Form-36 Health Survey (SF-36) will be completed at inclusion and at the final visit that will take place 30 days after the main surgery (with +/- 15-day window). It would be performed by telephone, in the outpatient consultation or in the hospital if the patient continues to be hospitalized.
Measured: From inclusion date to 30 days (with +7 window) after the main surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Aug 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- Collaborators
- Sociedad Espanola de Angiologia y Cirugia Vascular
- Responsible party
- Principal investigator, Ana Apodaka Diez, Biobizkaia Health Research Institute
- Investigators
- Ana Apodaka Diez, MD, Principal investigator, Vascular SurgeonJose Manuel Rodriguez Chinesta, MD, Principal investigator, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083755
- Sponsor's protocol ID
- 2018-003714-40
- Other IDs
- 2018-003714-40, 2018
- Acronym
- IRONPAD
- Status last verified
- Jan 2023
- First submitted
- 1 Sep 2019
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be send to publication in the next months
Publications
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
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.
PubMed 21353606Gonzalez 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.
PubMed 20462573Musallam 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.
PubMed 21982521Munoz 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.
PubMed 23588429Baron 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.
PubMed 24829444Fowler 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.
PubMed 26349842Glance 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.
PubMed 21239971Zollo 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.
PubMed 23351234Kougias 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.
PubMed 23384496Dunkelgrun 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.
PubMed 18394458Desormais 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.
PubMed 24935912Toor 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.
PubMed 19631867Preciado 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
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.
PubMed 19880828
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With Lower Extremity Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04083755
- Acronym / sponsor ID
- IRONPAD / 2018-003714-40
- Conditions
- Anemia, Peripheral Arterial Occlusive Disease
- Keywords
- anemia, iron, surgery, PAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- Collaborators
- Sociedad Espanola de Angiologia y Cirugia Vascular
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Line A | Active comparator | Drug: Ferric Carboxymaltose Injection [Injectafer]One dose of Ferric carboxymaltose (1000mg) intravenous. Duration of administration 15 minutes. |
| Line B | Other | Other: no treatment or oral iron supplementationNo treatment or treatment oral with iron supplementation if iron-deficiency anemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose Injection [Injectafer]Also: Ferinject1000mg intravenous | Drug | Line A |
| no treatment or oral iron supplementationNo treatment or treatment oral with iron supplementation if iron-deficiency anemia | Other | Line B |
Primary outcome
To reduce the incidence of transfusion (receiving any volume of 1 unit or more than 1 unit of packed red cells) from randomisation up to 30 days (with +/- 15-day window) after the main surgery
Time frame: From inclusion date to 30 days (with +7 window) after the main surgery
Number of red blood cell units of or any other blood component transfused during the surgical procedure and from the postoperative period until discharge. If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat.
6 secondary outcomes
Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge.
Time frame: From inclusion date to 30 days (with +7day window) after surgical procedure
Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb
Time frame: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on the length of hospital stay
Time frame: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on morbidity
Time frame: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on mortality
Time frame: From inclusion date to 30 days (with +7 window) after the main surgery
Impact of anemia and its treatment on quality of life
Time frame: From inclusion date to 30 days (with +7 window) after the main surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- BackgroundEsteban 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
- Background: PubMed 21353606Vega 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.
- Background: PubMed 20462573Gonzalez 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.
- Background: PubMed 21982521Musallam 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.
- Background: PubMed 23588429Munoz 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.
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- Individual participant dataSharing planned: Yes. Study protocol will be send to publication in the next months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Apodaka Diez, MD principal investigator
Vascular Surgeon
Jose Manuel Rodriguez Chinesta, MD principal investigator
Internal Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Carboxymaltose Injection [Injectafer] and no treatment or oral iron supplementation in people with Anemia and Peripheral Arterial Occlusive Disease, run by Biobizkaia Health Research Institute at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Apodaka, MD (34946006000, ANA.APODAKADIEZ@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To reduce the incidence of transfusion (receiving any volume of 1 unit or more than 1 unit of packed red cells) from randomisation up to 30 days (with +/- 15-day window) after the main surgery (time frame: From inclusion date to 30 days (with +7 window) after the main surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083755, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.