The Effect of Platelet Rich Pasma on Strenal Healing Post Median Strenotomy in Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- sternal stability and absence of dehiscence
研究概览
简要总结
Platelet-rich plasma (PRP) is an autologous concentration of human platelets in a small volume of plasma.
Because it is an autogenous preparation, PRP is inherently safe and therefore free from concerns over transmissible diseases such as HIV and hepatitis.
Its power of regeneration already proved by orthopedics and dentists in their trials to regenerate cartilages .We will use it to know its ability to enhance healing of sternum in vulnerable patients to sternal dehiscence after open heart surgery .
详细描述
- INTRODUCTION Successful healing of the sternum after open heart surgery is a complicated phenomenon because of the natural body ability often fails to efficiently repaired of the sternum in patients after open cardiac surgery (Everts 2006). Recent evidence based data suggested new modalities to increase the quality and accerelate sternal healing in high risk patients after open heart surgery vulnerable for early sternal dehiscence (Liu 2002) . PRP considers as an attractive alternative option in that manner. Marx and associates demonstrated the positive influence of PRP on bone regeneration and healing since 1998 (Marx 1998 ) . Autologous PRP carries minimal risk of infectious diseases transmission, immunologic reactions, and rejection. PRP with concentrations 4 to 5 folds of the normal average platelet (1,100,000 platelets/μl ) proved to have a remarkable increase in bone mineral density and regeneration . the market for PRP grows from $45 million in 2009 to more than $120 million by 2016 (Dawood 2018 ). Multiple factors affect the PRP efficacy in sternal bone healing and regeneration process. Platelet preparation before surgical application is an area of concern with PRP. For this issue, an appropriate anticoagulant must be used to prevent the early spontaneous activation of the platelets (Kassolis 2000 ). Several anticoagulants have been employed for PRP preparation including heparin, citrate, acid-citrate-dextrose solution A or anticoagulant citrate dextrose-A ,citrate-phos phate-dextrose ,citrate-theophylline-adenosine- dipyrimadole and ethylene diamine tetra- acetic acid moreover, several manual or automated systems have been designed for preparing PRP including clinical laboratory methods and kits (Carlson 2002). PRP produced by single- or double-step centrifugation technology via platelet-pheresis (autologous selective filtration )and the cell separators,However, these methods are rarely used nowadays, due to several factors including high cost, large volume of peripheral blood should be harvested from the patients, and potentially damage to the platelet (Dhurat 2014) . Commercially available PRP kits and devices differ in ease of use, one or two step centrifugation protocols, centrifugation speed, final PRP volume, platelet count and activation, platelet and growth factor concentrations, and final RBCs' and WBCs' count.Nevertheless, the cost of the commercial kits for PRP processing is still a challenge (Trebinjac 2020) .
- AIM/ OBJECTIVES :
To study the Effect of platlet rich plasma on sternal healing post median sternotomy in Patients undergoing open heart surgery 3. METHODOLOGY:
- Type of Study: prospective clinical trial propensity matched comparative study
- Study Setting: Patients refered to our Cardiothoracic department, Faculty of medicine, Ain Shams University and ain shams specialized hospital to perform open heart surgery who fulfill our inclusion charateria.
- Study Period: It will be performed between march 2020 and january2022
- Study Population:
- Inclusion Criteria: Patients with one of which
- patients will under go open heart surgery with BMI >30 or
- diabetic patients
- patients with history of chest wall radiotherapy exposure or
- bilateral internal mammary artery harvesting .
- age > 70 years old -Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 70 Years 至 90 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with one of which
- •patients will under go open heart surgery with BMI >30 or
- •diabetic patients
- •patients with history of chest wall radiotherapy exposure or
- •bilateral internal mammary artery harvesting .
- •age > 70 years old
排除标准
- •patient with history of open heart surgery 2- patients with preoperative HB level <11 3-All emergency and urgency cardiothoracic surgery
研究组 & 干预措施
We will apply 10cm plasma contain 1 million platlets on the sternal edge before sternal closure
We will apply 10cm plasma contain 1 million platlets on the sternal edge before sternal closure
干预措施: platlet rich plasma on sternal healing post median sternotomy (Drug)
We will apply 10cm saline on the sternal edge before sternal closure
We will apply 10cm saline on the sternal edge before sternal closure
干预措施: platlet rich plasma on sternal healing post median sternotomy (Drug)
结局指标
主要结局
sternal stability and absence of dehiscence
时间窗: after the first 3 months of surgery
Radiographic strenal healing score information was collected from 50 patients during clinical follow-up determined by CT chest 3D axial slices analysis at five locations ( manubrium, top of aortic arch, main pulmonary artery , aortic root and aortopulmonary window) using 5 - points quantitative scale 0:minimal healing 1. no signs of healing 2. mild healing 3. moderate healing 4. complete healing
次要结局
未报告次要终点
研究者
Dr. Hamdy Singab
Professor
Ain Shams University
