EUCTR2011-005650-54-NL进行中（未招募）不适用
Prothrombin complex concentrate in the reduction of blood loss during otrhotopic liver transplantation. - PROTON trial
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •- >18 years
- •- Eligible for orthotopic liver transplantation
- •- Signed informed consent
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Split liver transplantation
- •- Heterotopic liver transplantation
- •- Scheduled multiorgan transplantation,
- •- Scheduled living related-donor transplantation
- •- Documented congenital coagulation disorders
- •- Documented history or presence of arterial or venous thrombosis
- •- Treatment with warfarin
- •- Fulminant hepatic failure without previous history of liver disease
- •- Documented coronary artery disease
- •- Documented thrombophilia
- •- Hypercoagulability as evaluated by preoperative TEG or ROTEM
研究者
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Prothrombin complex concentrate in liver transplantatioliver cirhosiscoagulopathybleedingMedDRA version: 14.1Level: PTClassification code 10009802Term: CoagulopathySystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: PTClassification code 10049227Term: Bleeding time abnormalSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2011-005650-54-FIniversity Medical Center Groningen
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已完成
4 期
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