临床试验/NCT01201070

NCT01201070

Unknown

4 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2009年9月

适应症Aortic Valve Insufficiency Aortic Valve Stenosis Mitral Valve Insufficiency Mitral Valve Stenosis Acute Coronary Syndrome

干预措施antithrombin III

概览

阶段: 4 期
干预措施: antithrombin III
疾病 / 适应症: Aortic Valve Insufficiency
发起方: University of Bari
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.
最后更新: 15年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2009年9月

结束日期

2011年11月

最后更新

15年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

University of Bari

入排标准

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

研究组 & 干预措施

TREATMENT WITH ANTITHROMBIN

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

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)

研究点 (1)

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