EUCTR2021-000740-21-IT进行中（未招募）1 期
Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor. - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor
- •Aged =18 years
- •Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legally authorised representative on their behalf
- •Patients who have acute major bleeding defined as follows:
- •- Bleeding that is potentially life-threatening or uncontrolled, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, or low cardiac output that cannot be otherwise explained
- •- Symptomatic bleeding in critical organs (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome)
- •- Acute overt bleeding associated with a fall in haemoglobin (Hgb) level of =2 g/dL, OR a Hgb level =8 g/dL if no baseline Hgb level is available, OR in the opinion of the investigator that the patient’s Hgb level will fall to =8 g/dL with resuscitation
- •Patients with baseline anti-factor Xa activity equivalent to at least 100 ng/mL according to the available test (e.g., chromogenic assay)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Patients with bleeding that is immediately life-threatening
- •Patients with ‘Do not resuscitate’ (DNR) orders
- •Patients with acute trauma for which reversal of DOAC therapy with factor Xa inhibitor alone would not be expected to control the bleeding event
- •Hgb decrease without accompanying evidence of source of bleeding
- •Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within the preceding 3 months
- •Patients with a history, within the last 3 months, of disseminated intravascular coagulation (DIC) or hyperfibrinolysis
- •Patients with a known congenital coagulation disorder
- •Known inhibitors to coagulation factors II, VII, IX, or X; or heparin-induced, type II thrombocytopenia
- •Known hypersensitivity to plasma-derived products
- •Patients who received haemostatic agents, including plasma, platelets, PCC, activated PCC (aPCC), recombinant factor VIIa, or recombinant factor Xa inactivated-zhzo (andexanet alfa), for the current bleeding event prior to enrolment (antifibrinolytic drugs and local haemostatic agents are allowed)
- •Patients who received clopidogrel within 5 days or prasugrel within 7 days or ticagrelor within the 48 hours preceding the bleeding event
- •Patients on enoxaparin therapy for thromboembolic prophylaxis
- •A score of less than 7 on the Glasgow Coma Scale or an estimated intracerebral haematoma volume of more than 60 mL
- •Patients with expected survival of less than 3 days
- •Patients scheduled to undergo surgery in less than 12 hours, with the exception of some minor/invasive procedures that are allowed for diagnostic or therapeutic reasons (see Section 4.1.2)
- •Patients who are pregnant or breastfeeding at the time of enrolment
- •Patients previously enrolled in this study
- •Patients participating in another interventional clinical treatment study currently or during the past 1 month prior to study inclusion
研究者
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Study to demonstrate the efficacy and safety of OCTAPLEX in patients with acute major bleeding that are taking direct oral anticoagulant.Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitorMedDRA version: 20.0Level: LLTClassification code 10009731Term: Coagulation disorderSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2021-000740-21-ATOctapharma AG260
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Study to demonstrate the efficacy and safety of OCTAPLEX in patients with acute major bleeding that are taking direct oral anticoagulant.Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitorMedDRA version: 20.0Level: LLTClassification code 10009731Term: Coagulation disorderSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2021-000740-21-DEOctapharma AG260
终止
3 期
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