ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of perioperative allogenic blood transfusion.
研究概览
简要总结
The introduction of a modified perioperative patient blood management protocol with intravenous iron intervention for iron deficiency anaemic patients would reduce the need for allogenic blood transfusion and reduce perioperative morbidity and mortality.
详细描述
Patient blood management (PBM), refers to "the timely application of evidence based medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis and minimize blood loss in an effort to improve patient outcome.
PBM relies on three corresponding aspects:
- Optimising haemopoiesis,
- Minimising bleeding and blood loss
- Harnessing and optimising physiological tolerance of anaemia.
Therefore, this randomised control trial aims to study the effect of applying a modified patient blood management protocol on the perioperative allogenic blood transfusion incidence, mortality and morbidity in patients undergoing major surgery in gynaecology, intraabdominal surgery and orthopaedics comparing with current practice.
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
盲法说明
patient will be randomised into ProPBM and standard care arm
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics
- •Major surgery defined as either Intrabdominal surgery or main joint surgery, Risk of blood loss >15% blood volume
- •Aged between 18 to 80 years of age
- •The patient must be willing and able to provide written informed consent for the study
排除标准
- •Allergy or known sensitivity to parenteral iron
- •Hypersensitivity to the active substance, Iron(III) Isomaltoside or any of its excipients listed in the summary of product characteristics
- •Patients with iron overload
研究组 & 干预措施
ProPBM
Pre-operative: patient will be screened for iron deficiency and anemia and administered IV monofer Intra-operative:IV tranexamic Acid 1gm will be administered at the beginning of surgery and blood transfusion triggered by Allowable blood loss Post-operative: IV Iron monofer will be given to those with estimated blood loss >1L and subsequent post operative follow up till 6month
干预措施: MonoFer (Drug)
结局指标
主要结局
Incidence of perioperative allogenic blood transfusion.
时间窗: Participants will be followed from date of hospital entry until date of discharge up to 6 months
To assess the incidence of allogenic blood transfusion occurring within the total length of hospital stay within the same admission of a surgical procedure performed under general or regional anaesthesia
次要结局
- Quality of Life of patient(preoperative (baseline), one month, six month)
- Mortality rate(Participants will be followed up expected till 6 months)
- Total hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Change in haemoglobin (Hb) concentrations from baseline(Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks)
- Postoperative Morbidity(Day one postoperative, postoperative one week,postoperative one month, postoperative six month)
研究者
Tan Jenq Uei
Trainee of Master of Anaesthesiology University of Malaya
Ministry of Health, Malaysia