Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery - TICAdSORB
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery
研究概览
简要总结
Cardiac surgery is at high risk of intraoperative bleeding. Inhibitors of the P2Y12 platelet receptor, such as ticagrelor, are recommended in patients with acute coronary stroke (ACS) to reduce the incidence of major cardiovascular events. Nevertheless, some patients may require coronary artery bypass graft under cardiac bypass after ticagrelor administration. This administration within 48 hours prior to surgery is associated with a significant increase in bleeding and related poor outcomes, notably because platelet transfusion fails to reverse ticagrelor induced platelet dysfunction. Conversely, waiting several days to plan surgery, in the idea of clearing blood from ticagrelor, exposes to a risk of ischemic recurrence.
Another situation where ticagrelor administration may impend prognosis is emergent aortic surgeries, including aortic dissection or aneurysm rupture. Ticagrelor is frequently administrated because symptoms can mimic ACS, but it may increase bleeding and transfusion by at least 50%.
Several case reports and cohorts described blood hemadsorption, using the Cytosorb® blood purification system (Cytosorb®ents, USA) as a reversal therapy for ticagrelor, reducing bleeding. Cytosorb® is a polymeric beads system with a large exchange surface, enabling the adsorption and removal of molecules of intermediate sizes (< 60 kDa). It has been described to reduce the plasma levels of ticagrelor, with a removal up to 75% after 60 min. It can be connected directly to the heart-lung machine. Its use during cardiac bypass is simple and has not described to induce additional hemolysis.
We hypothesize that the use of Cytosorb® hemoadsorption during cardiac bypass would reduce the incidence of moderate to massive bleeding in patients receiving ticagrelor within 48 hours prior to surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patient or patient's representative having read and understood the information letter and signed the consent form
- •Age ≥ 18 y/o
- •Ticagrelor administration within 48 hours prior to surgery
- •Cardiac surgery with cardiac bypass
- •Patient affiliated with, or beneficiary of a social security (health insurance) category.
- •Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile):
- •with effective contraception (Cf. CTCG) (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) since 1 month, during study period
- •negative blood pregnancy test by b-HCG at inclusion.
- •Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- •Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
排除标准
- •Concomitant antiplatelet drugs or ongoing anticoagulants other than aspirin and heparin
- •Ongoing systemic infection (including active endocarditis)
- •Ongoing treatment with an antibiotic or antifungal at high risk of removal by Cytosorb®: teicoplanin, vancomycin, linezolid, gentamycin, amphotericin B liposomal, azole drugs or fluconazole
- •Ongoing treatment with an anticonvulsant at high risk of removal by Cytosorb®: phenytoin, phenobarbital or valproic acid.
- •Contraindications to Cytosorb® (known preoperative platelet count < 20 000/mm3, Sickle cell disease crisis, history to heparin-induced thrombopenia, body mass index ≥ 40 kg/m², hypersensitivity to a component, Any pre-existing contraindication to extracorporeal therapy (CPB))
- •Cardiac surgery for ventricle assistance device or transplantation
- •Preoperative critical state
- •Chronic pathology with life expectancy less than 1 month
- •Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception
- •Absence of affiliation to a social security program
- •Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
- •Person consenting to the research participating having participated to another trial within a period of one week
- •Person participating to another interventional research
研究组 & 干预措施
experimental arm
干预措施: Device: Cytosorb hemoadsorption (Device)
control arm
干预措施: Device: Sham extracorporeal circuit (Device)
结局指标
主要结局
benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery
时间窗: within the 48 first hours post-CPB
Incidence of a moderate, severe or massive bleeding defined by an UDPB (Universal Definition for Perioperative Bleeding) score ≥ 2/4 within the 48 first hours post-CPB.
次要结局
- compare the distribution of bleeding severity between groups(48 hours after surgery)
- compare the intensity of intraoperative bleeding(48 hours after surgery)
- compare the surgical reintervention rate due to bleeding between groups(90 days)
- compare between groups, the risk of other hemorrhagic complications(90 days)
- compare between groups the risk of major adverse cardiovascular events(90 days)
- compare between groups, the risk of any complication in the composite outcome of acute kidney injury(90 days)
- compare quality of life between groups(90 days)
- Red blood cell transfusion at 90 days(Baseline to 90 days)
- Fresh frozen plasma transfusion at 90 days(Baseline to 90 days)
- Prothrombin complex concentrate use at 90 days(Baseline to 90 days)
- Platelet transfusion at 90 days(Baseline to 90 days)
- Fibrinogen concentrate administration at 90 days(Baseline to 90 days)
- Activated factor VII administration at 90 days(Baseline to 90 days)