NCT01201070Unknown4 期
Effects of the Administration Of Antithrombin on the Coagulation Status and on the Inflammatory Response in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
University of Bari1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
研究概览
简要总结
General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative Antithrombin (AT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were candidates for cardiac surgery intervention in extracorporeal circulation
排除标准
- •positive history for allergic reactions to AT III
- •cardiac surgery "Off-Pump"
- •administration of AT during surgery or within 48 h
- •treatment with drugs and non-steroidal steroids within 48 h prior
- •disorders of coagulation
- •platelets <30,000
- •pre-existing IRC in dialysis treatment
- •severe liver failure
- •enlistment in another trial in the last 30 days
- •hypothermia
- •emergency
- •reopening
- •length of CEC> 180 minutes
- •subjects incapable of giving legal consent
研究组 & 干预措施
TREATMENT WITH ANTITHROMBIN
Active Comparator
3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
干预措施: antithrombin III (Drug)
结局指标
主要结局
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
时间窗: until 5 days after surgey
次要结局
- Number of participants with infection as a measure of safety.(until 5 days after surgery)
- Number of participants with delirium as a measure of safety.(until 5 days after surgery)
- Number of participants with wound complication as a measure of safety.(until 5 days after surgery)
- Number of participants with multi organ failure as a measure of safety.(until 5 days after surgery)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac SurgeryCardiopulmonary BypassNCT01530737The Hospital for Sick Children18
Enrolling By Invitation
2 期
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous ThromboembolismTrauma InjuryThromboembolismVenous ThromboembolismNCT05794165Bryan Cotton314
终止
2 期
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe SepsisDisseminated Intravascular CoagulationNCT00506519LEO Pharma25
招募中
不适用
The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke PatientsIschemic StrokeNCT03571763General Hospital of Shenyang Military Region1,875
已完成
不适用
Impact of antithrombotic agent on the clinical course after pancreatectomyperioperative complicationJPRN-UMIN000027919ara Medical University1,000