EUCTR2008-005653-37-DK进行中（未招募）1 期
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 个研究点目标入组 74 人开始时间: 2013年3月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
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
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1 Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
- •2. Deep Coma (GCS = 5) at the time of admission or before intubation if intubated outside the hospital
- •3. Known thrombocytopenia (platelets <50,000/?L), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)
- •4. Pregnancy and lactation
- •5. Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke
- •6. Acute or known congestive heart failure (NYHA III, IV)
- •7. Pulmonary edema
- •8. Known history of claudicatio intermittens
- •9. Known recent thrombotic event < 30 days
- •10. Known active malignant disease
- •11. Known alcohol or other drug abuse
- •12. Known previous disability (mRS > 2 before stroke occurred)
- •13. Known liver failure (child-pugh-score C)
- •14. 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
- •15. Known allergy to heparin or history of heparin induced thrombocytopenia.
- •16. Previous participation in this trial
- •17. 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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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-VKAIntracerebral hemorrhage (ICH) in patients related to vitamin K antagonistsMedDRA version: 14.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disordersEUCTR2008-005653-37-DEniversityhospital of Heidelberg
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