Preoperative, Single-dose Intravenous Iron Formulation to Reduce Post-surgical Complications in Patients Undergoing Major Abdominal Surgery: a Pilot Randomised Control Trial (PIRCAS Trial - Pilot)
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of the study
研究概览
简要总结
Preoperative anemia is common worldwide, ranging from 25% in knee arthroplasties to 60% in colorectal malignancies. In Singapore, about a quarter (27%) of all patients have anaemia prior to operation at a main tertiary center. Currently, the rate of preoperative anemia in Singapore General Hospital (SGH) is 26.6%.
This is an alarming public health issue as the negative impact of preoperative anemia on post-surgical outcomes has been well documented and include increased rates of perioperative blood transfusion, mortality, adverse cardiac and non-cardiac complications including pulmonary complications, wound infections, systemic sepsis and venous thromboembolism, as well as prolonged length of hospital stay and increased healthcare costs. These data suggest that reducing preoperative anemia prior to major surgery is imperative to improve clinical outcomes and decrease healthcare costs.
This study responds to an urgent need to optimize the current standard practice for managing preoperative anemia. It is designed as a randomised, open-label, study to investigate the efficacy of intravenous iron compared to oral iron in patients with anemia undergoing major surgery to reduce surgical complications. To demonstrate the feasibility of conducting such trial in a larger scale, a pilot study with the same design will be conducted. The findings of this pilot study will also inform the study design and sample size for the larger study.
If successful, the results will inform clinical practice guidelines, result in better patient and clinical outcomes, reduce burden on the health care system, and change health-related policy. For example, all forms of intravenous iron therapy are currently not subsidized by the Singapore government which is in stark contrast with allogenic blood transfusion, which is subsidised and readily available at a substantially reduced rate to patients. Hence, it will cost the patients more out of pocket to be treated with intravenous iron than to have allogenic blood transfusion. Incorporating a preoperative anemia correction protocol in the current surgical pathway is a potential strategy to combat healthcare cost inflation and the increasing demand for blood products.
详细描述
Preoperative anemia is common worldwide, ranging from 25% in knee arthroplasties to 60% in colorectal malignancies. In Singapore, about a quarter (27%) of all patients have anaemia prior to operation at a main tertiary center. Currently, the rate of preoperative anemia in Singapore General Hospital (SGH) is 26.6%.
This is an alarming public health issue as the negative impact of preoperative anemia on post-surgical outcomes has been well documented and include increased rates of perioperative blood transfusion, mortality, adverse cardiac and non-cardiac complications including pulmonary complications, wound infections, systemic sepsis and venous thromboembolism, as well as prolonged length of hospital stay and increased healthcare costs. These data suggest that reducing preoperative anemia prior to major surgery is imperative to improve clinical outcomes and decrease healthcare costs.
This study responds to an urgent need to optimize the current standard practice for managing preoperative anemia. It is designed as an open-label, parallel design pilot randomised control trial to determine the feasibility of conducting a larger scale study powered to investigate reduction in complication rate. There will be two arms, intervention (IV FCM 15mg/kg, up to 1000 mg) and usual care (Ferrous fumarate 200mg twice daily). All participants will be followed for three months from date of operation.
60 participants will be randomly allocated in a 1:1 ratio to either preoperative FCM (intervention) or oral iron (standard care). Participants are stratified to surgical type (upper or lower intestinal surgeries) and surgical approach (laparoscopic or open). The sample size was selected based on the observation that at least 12 participants per group provide adequate measurement precision and power to detect associations. The study aims to balance 15 participants per stratum to account for dropouts and loss to follow up.
Written informed consent will be obtained prior to enrolment in the study. Study data will be entered into a secure data management system and retained for up to 6 years after the study ends, as per institutional guideline. There will be no procedures recorded on electronic media.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective major benign or malignant abdominal surgery
- •Procedures expected to last 2 hours and/or more OR Anticipated blood loss greater than 500ml
- •PAC clinic scheduled before 1 - 4 weeks before surgery
- •Male Hb less than 13.0 Gram Per Deciliter OR Female Hb less than 12.0 Gram Per Deciliter
- •Diagnosed as having Iron Deficiency: Serum Ferritin level less than 100 Microgram Per Liter OR Serum Ferritin is between less than100 Microgram Per Liter - less than 300 Microgram Per Liter + Transferrin Saturation is less than 20 percent
- •Patient is able to receive the infusion 1 - 4 Weeks [at least 7 Days] before the planned operation date.
- •Patient is able to provide written, informed consent
排除标准
- •Know history of acquired iron overload
- •Family history of hemochromatosis or thalassemia or transferrin saturation (TSAT) more than 50 percent
- •Treatment with erythropoietin in the previous 12 weeks (3months)
- •Known hypersensitivity to Ferric Carboxymaltose or its excipients
- •Patients with severe asthma or severe allergy (requiring hospitalization within the last 12 months)
- •Pregnancy
- •Age less than 21 years
- •Inability to communicate or understand study instructions and questionnaire which will be provided in either English, Chinese, Malay or Tamil
- •Patient involvement in another Investigational Medicinal Product Trial within the previous 4 weeks prior to randomization that may impact the results of the PIRCAS trial
研究组 & 干预措施
IV Ferric Carboxymaltose
Patients in the intervention group will receive preoperative IV ferric carboxymaltose, given as a single dose (15 mg/kg body weight, to a maximum dose of 1000 mg) over 30 minutes.
干预措施: Ferric carboxymaltose (Drug)
Oral Ferrous Fumarate
Patients will be given oral iron as per current clinical protocol, which is Ferrous fumarate 200mg twice daily
干预措施: Ferrous Fumarate (Drug)
结局指标
主要结局
Feasibility of the study
时间窗: four months
The study can be conducted feasibly at the research site as evidence by: 1. Number of participants who receive study drug within 5 days of enrollment 2. Number of participants recruited over 4 months 3. Number of participants completed the study
次要结局
- the effect of intravenous FCM compared with oral iron on health related quality of life(three month)
- effectiveness of a single preoperative dose of IV FCM in treating iron deficiency anemia(one month)
- the effect of intravenous FCM compared with oral iron on post operative morbidities(six months)
- the effect of intravenous FCM compared with oral iron on mortality(six month)
- the effect of intravenous FCM compared with oral iron on perioperative morbidities(six month)