EUCTR2008-005653-37-DE进行中（未招募）不适用
Multicenter, prospective randomized trial on the use of prothrombin complex and fresh frozen plasma in patients with intracerebral hemorrhage related to vitamin K antagonists (VKA) - ICH-VKA
niversityhospital of Heidelberg0 个研究点开始时间: 2009年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Spontaneous ICH (intraparenchymal), subdural hematoma (SDH) diagnosed by CT scanning = 12 hours after onset of symptoms. In case of unknown time of symptom onset: time between last seen in healthy condition and first CCT = 12 hours.
- •2. Therapy receiving vitamin K antagonists (VKA)
- •3. International Normalized Ratio (INR) = 2
- •4. Male or female subjects, age = 18 years
- •5. Signed informed consent form, or signed informed consent by a legal representative, judicial consent in cases where no legal representative is available in time, or consent of an independent physician familiar with the indication in cases where the first three possibilities can not be realized.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with primary ICH
- •2. Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
- •3. Deep Coma (GCS = 5) at the time of admission or before intubation if intubated outside the hospital
- •4. Known thrombocytopenia (platelets <50,000/?L), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)
- •5. Pregnancy and lactation
- •6. Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke
- •7. Acute or known congestive heart failure (NYHA III, IV)
- •8. Pulmonary edema
- •9. Known history of claudicatio intermittens
- •10. Known recent thrombotic event < 30 days
- •11. Known active malignant disease
- •12. Known alcohol or other drug abuse
- •13. Known previous disability (mRS > 2 before stroke occurred)
- •14. Known liver failure (child-pugh-score C)
- •15. History of hypersensitivity to the investigational products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
- •16. Known allergy to heparin or history of heparin induced thrombocytopenia.
- •17. Previous participation in this trial
- •18. Participation in ANY clinical trial within 30 days of entry into the trial and during the trial
- •19. Concomitant use of antithrombotic (with PTT > 1.5 of normal PTT), thrombolytic treatment. – Use of aspirin, clopidogrel or dipyridamole or combinations thereof (e.g. Aggrenox®) is not an exclusion criterion. These drugs should be discontinued and not restarted earlier than 24 hours after normalization of INR if indicated.
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