Prospective, Observational, Non-interventional Open-Label, International, Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants or Vitamin K Antagonists
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- In hospital mortality up to 30 days after admission
研究概览
简要总结
Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, or during emergency operations
详细描述
The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots in patients needing urgent interventions/operations or in severe bleeding patients treated with oral anticoagulants.
By collecting case reports from several university hospitals and clinics, different treatment strategies in clinical practice will be observed and evaluated, and may serve as a comprehensive information resource for the safe management with DOA, but also with the long-term anticoagulation based on coumarin derivatives in the near future.
The current objective of this registry is to:
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Document the clinical course and outcome of various clinical bleeding events associated with DOA or VKA in patients with severe life-threatening bleeding making intervention necessary
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Document the clinical course and outcome of urgent surgical interventions within 24 hours after admission in patients under DOA or VKA treatment.
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Characterisation of therapeutic strategies in stopping acute life-threatening bleeding including following agents and methods:
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blood transfusion,
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platelet concentrates
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reversal agents [e.g. vitamin K, prothrombin complex concentrate (PCC), activated PCC (aPCC), activated factor VII (aVII), fibrinogen concentrate, fresh frozen plasma (FFP)]
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specific antidots, e.g. idarucizumab, Andexanet alpha
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haemodialysis
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desmopressin
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tranexamic acid
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no specific treatment in respect to the above mentioned treatments (e.g. stop of medication and waiting until anticoagulant effect of DOA is decreased).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group a) Bleeding patients:
- •Anticoagulated patients with DOA or VKA with clinically overt major bleeding according to a specified ISTH definition for non-surgical patients:
- •Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome
- •Bleeding causing a fall in hemoglobin level of 2 g L-1 (1.24 mmol L-1 ) or more leading to transfusion of two or more units of whole blood or red cells.
- •Group b) Acute surgical need patients
- •treated with DOA or VKA and who need urgent operation which cannot wait (< 24 h after last intake of drug)
- •with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)
- •provides informed consent after the acute event
- •Exclusion Criteria for Group a and b:
- •Conscious patient by him-/ herself or his/ her available legal representative does not agree with inclusion in the registry
- •Age < 18 years
- •Concomitant participation in an interventional trial
排除标准
- 未提供
结局指标
主要结局
In hospital mortality up to 30 days after admission
时间窗: up to 30 days after hospital admission
Death rate (number of deaths)
次要结局
- Fatality rate caused by unstoppable bleeding(up to 30 days after hospital admission)
- Definition of supportive measures being effective in stopping bleeding(up to 30 days after hospital admission)
- Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding(up to 30 days after hospital admission)
- Causality assessment: Relation of SAE to anticoagulant medication(up to 30 days after hospital admission)
- Stop of bleeding defined according to the treating physicians(up to 30 days after hospital admission)
- Use versus no use of reversal agents - difference in outcome?(up to 30 days after hospital admission)
- Blood loss, number of transfusions necessary(up to 30 days after hospital admission)
- Satisfaction of surgeon during and after surgery concerning bleeding(up to 30 days after hospital admission)
- Use versus no use of reversal agents - difference in blood loss and number of transfusions(up to 30 days after hospital admission)
- Delay in performance of surgery due to anticoagulation(up to 30 days after hospital admission)