Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With Lower Extremity Peripheral Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Line A
One dose of Ferric carboxymaltose (1000mg) intravenous. Duration of administration 15 minutes.
干预措施: Ferric Carboxymaltose Injection [Injectafer] (Drug)
Line B
No treatment or treatment oral with iron supplementation if iron-deficiency anemia
干预措施: no treatment or oral iron supplementation (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge.(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(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(From inclusion date to 30 days (with +7 window) after the main surgery)
- Impact of anemia and its treatment on morbidity(From inclusion date to 30 days (with +7 window) after the main surgery)
- Impact of anemia and its treatment on quality of life(From inclusion date to 30 days (with +7 window) after the main surgery)
- Impact of anemia and its treatment on mortality(From inclusion date to 30 days (with +7 window) after the main surgery)
研究者
Ana Apodaka Diez
Vascular Surgeon
Biocruces Bizkaia Health Research Institute