NCT06096116招募中3 期
Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Octapharma
- 入组人数
- 120
- 试验地点
- 27
- 主要终点
- Restoring heparin responsiveness
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
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, Care Provider, Outcomes Assessor)
盲法说明
Triple (Participant, Care Provider, Outcomes Assessor) The patients, care provider administering IMP, and outcomes assessors will be blinded from treatment allocations. Delegated study personnel preparing the IMP will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned cardiac surgery with CPB
- •Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
- •Patients between 18 and 85 years of age, inclusive
- •Freely given written or electronic informed consent
- •In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
排除标准
- •Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
- •vitamin K antagonists (within 3 days)
- •direct oral anticoagulants (within 2 days)
- •thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- •ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- •glycoprotein IIb/IIIa antagonist (within 24 hours)
- •Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- •Renal insufficiency, defined as serum creatinine level >2.0 mg/dL
- •Thrombocytosis, defined as platelet count >400,000 per μL
- •Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
- •History of anaphylactic reaction(s) to blood or blood components
- •Refusal to receive transfusion of blood or blood-derived products
- •Current participation in another interventional clinical trial or previous participation in the current trial
- •Treatment with any IMP within 30 days prior to screening visit
研究组 & 干预措施
High-dose Atenativ
Experimental
Patients will receive a single bolus of 60 international units (IU)/kg body weight (BW) Atenativ.
干预措施: Human plasma derived antithrombin (Drug)
Placebo
Placebo Comparator
Patients will receive a saline bolus dose
干预措施: Placebo (Drug)
Low-dose Atenativ
Experimental
Patients will receive a single bolus of 30 international units (IU)/kg body weight (BW) Atenativ.
干预措施: Human plasma derived antithrombin (Drug)
结局指标
主要结局
Restoring heparin responsiveness
时间窗: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
The percentage of patients in each group in whom no further therapy containing antithrombin (i.e. frozen plasma or other antithrombin concentrates) is needed for restoring pre-CPB heparin responsiveness after administration of Atenativ or placebo, and for maintaining it during CPB
次要结局
- Amounts of further therapy for restoring heparin responsiveness(During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed))
- Change in activated clotting time (ACT) values(Within 5 minutes following intravenous administration of 500 U/kg unfractionated heparin (UFH) and between 2-10 minutes after IMP infusion)
- Change in antithrombin plasma levels(Within 10 minutes before IMP infusion and between 2 and 10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after the start of IMP infusion)
- Change in heparin usage(From end of IMP infusion to the end of surgery)
- FP unit use(From the start of IMP infusion until 24 hours following IMP infusion, and until discharge or 7 days after surgery, whichever comes first)
- Amounts of further antithrombin concentrate for maintaining heparin responsiveness(From placement of the final suture or staple until 24 hours following IMP infusion, to discharge or 7 days after surgery, whichever comes first)
- Transfusion of allogenic blood products(From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first)
- Administration of coagulation factor concentrates(From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first)
- Administration of other haemostatic-relevant therapies(From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first)
- Postoperative chest tube drainage(From the start of IMP infusion to 24 hours after infusion and until discharge or 7 days after surgery, whichever comes first)
- Need for reoperation due to bleeding(24 hours after the start of IMP infusion)
- Cell saver volume(During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed))
- Adverse events(From the start of IMP infusion until hospital discharge or 7 days after IMP administration, whichever comes first)
- Serious adverse events(From the start of IMP infusion until 28 days after IMP administration)
- Survival status(At hospital discharge or 7 days after IMP administration (whichever comes first) and at 28 days (+ 4 days) after IMP administration)
- Red Blood Cell count(Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion)
- White Blood Cell count(Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion)
- Haemoglobin levels(Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion)
- Haematocrit(Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion)
- Platelet count(Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion)
研究者
研究点 (27)
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