A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 14
- 主要终点
- ClearPlasma efficacy
研究概览
简要总结
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. To address this unmet need, PLAS-FREE LTD has developed ClearPlasma™, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.
详细描述
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. Bleeding complications are associated with worse clinical outcomes, including a higher risk of infection, ischemic events attributable to hypo-perfusion (e.g., myocardial infarction, acute kidney injury), in-hospital mortality, and transfusion-related adverse events. Additionally, bleeding complications are an important driver of blood product utilization in cardiac surgery. Coagulopathy and bleeding after cardiac surgery are often a multifactorial problem, thus there is unmet need to find new technologies that can give better care to these bleeding patients. In 2016, it was estimated that one million people throughout the world undergo cardiac surgery each year. Most of these surgeries are Coronary artery bypass grafting and valves replacement. Coronary artery bypass grafting (CABG) is still the most commonly performed cardiac surgery procedure worldwide, representing annual volumes of approximately 200,000 isolated cases in the US and an average incidence rate of 62 per 100,000 inhabitants in western European countries. Aortic valve replacement is procedure that treat diseases affecting the aortic valve, one of four valves that control blood flow through the heart. In the United States, it is estimated that 2.5% of the general population, 8.5% of those 65-74 years of age and 13.2% of those ≥75 years of age have moderate to severe valvular diseases. These surgeries are commonly done in the western countries, however, the ability to halt the bleed remain challenge for most clinicians. Failed or delayed treatment of a massive bleeding can result in irreversible end-organ damage (e.g., renal failure), cardiovascular events (e.g., stroke, myocardial injury) or death, accompanied by significantly increased costs.
Fibrin clot breakdown is actively mediated by plasmin, a serine protease which cleaves fibrin. Administration of plasma depleted of plasminogen, the precursor of plasmin, may shift the balance towards coagulation.
PLAS-FREE LTD has developed ClearPlasma™, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
After all applicable screening assessments have been performed, patients who have met all inclusion criteria and none of the exclusion criteria will be randomly allocated to one of the two treatment groups (with ratio 1:1) and will receive a unique computer-generated randomization number. Site stratified block randomization will be used during the study. Blocks length will have random length (e.g., 4, 6, 8). In order to reduce bias as much as possible, the trial will be double-blinded, keeping Sponsor, all patients and the Investigator blinded to the treatment. The randomization list will not be available to blinded personnel (such as Principal Investigator) involved in the conduct and evaluation of the trial until the trial database is locked.
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 aged ≥ 18 years
- •Patients undergoing isolated coronary artery bypass grafting or valve replacement surgeries with a cardiopulmonary bypass
- •Patients that need at least 2 units of plasma transfusion according to the physician's decision.
- •Patients understanding the nature of the study and providing their informed consent to participation;
- •Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
排除标准
- •Patients who underwent a plasma infusion in the 30 days before enrolment;
- •Patients in a life-threatening condition at the time of enrolment;
- •Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. hypovolemic shock, cardiogenic shock);
- •Transfusion of cryoprecipitate during procedure.
- •Patients suffering from Hemophilia A or B;
- •Patients suffering from venous and arterial thromboembolic events within 3 months before the enrolment;
- •Patients with increased risk of blood clotting, according to Investigator's judgement;
- •Patients with fluid accumulation in the brain at the time of enrolment.
- •Patients with retinal thrombosis at the time of enrolment;
- •Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate;
- •Patients suffering from known IgA deficiency at the time of enrolment;
- •Patients identified by the Investigator to have any underlying medical conditions that may preclude conduct of study procedure (i.e. making the administration of study treatment hazardous) or obscure the interpretation of safety objectives;
- •Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- •Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for 3 months later;
- •Female Patients of childbearing age (less than 12 months after the last menstrual cycle) who do not use adequate contraception*.
- •Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices.
结局指标
主要结局
ClearPlasma efficacy
时间窗: 30 days
Post-operative blood loss (mL) within 24 hours after surgery, defined as total output of mediastinal and pleural chest tubes. \[time frame: up to 24 hours after procedure\]
次要结局
- Mortality(30 days)
- Transfusion- related SAE(30 days)
- Hemoglobin levels(30 days)
- Post-operative blood loss(30 days)
- bleeding events-(30 days)
- In- hospital mortality(30 days)
- Length of stay in the ICU(30 days)
- Hospitalization Duration(30 days)
- Incidence of ischemic outcomes(30 days)
- Total blood loss(30 days)
- ClearPlasma(30 days)
- major bleeding(30 days)
- Number of blood units transfused(30 days)