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临床试验/NCT06612060
NCT06612060已完成不适用

Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery

Polychronis Antonitsis2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Prothrombin fragments 1+2 (F1+2)

研究概览

简要总结

The aim of the present strudy is to investigate whether the use of biocompatible extracorporeal circulation circuits with a special hydrophilic polymer coating without heparin causes a reduction in the activation of the coagulation mechanism and the formation of microthrombi in the circuit tubing. A total of 50 patients undergoing cardiac surgery with extracorporeal circulation will be randomized in two groups using a computer-generated algorithm. The first group (study group) will undergo cardiac surgery with a specialized biocompatible circuit with a hydrophilic coating, while the control group will be operated with the conventional non-coated extracorporeal circulation circuit. During the period of extracorporeal circulation, blood samples will be taken at predetermined times which will be analyzed with the ELISA technique to determine the levels of prothrombin fragments 1+2 (F1+2), thrombin/antithrombin complex (TAT) as well as platelet factor P-selectin. Moreover, sections of the circuit tubes will be examined under electron microscopy for quantitative evaluation of microthrombi detected on the walls. The expected outcome of the study is to establish, with the use of specific biochemical markers and electron microscopy the protective effect of biocompatible coated extracorporeal circulation circuits on the coagulation mechanism and platelet activation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, 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

入选标准

  • Planned surgery

排除标准

  • Need for emergency surgery
  • Serious hematological condition causing anemia, thrombocytopenia, etc.
  • Receiving immunosuppressive treatment
  • Inability to obtain consent

结局指标

主要结局

Prothrombin fragments 1+2 (F1+2)

时间窗: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation

Plasma levels of prothrombin fragments 1+2 (F1+2) (pg/ml) will be calculated at predetermined times using the ELISA technique

Thrombin/Antithrombin complex (TAT)

时间窗: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation

Plasma levels of thrombin/antithrombin complex (TAT) (pg/ml) will be calculated at predetermined times using the ELISA technique

Platelet factor P-selectin

时间窗: Change from baseline at 40 and 80 minutes after initiation of extracorporeal circulation

Plasma levels of platelet factor P-selectin (pg/ml) will be calculated at predetermined times using the ELISA technique

Circuit microthrombi

时间窗: Immediately after the cessation of cardiopulmonary bypass.

Quantitative evaluation of microthrombi on the walls of the circuit tubes as detected by electron microscopy.

次要结局

  • ICU stay(From the day of surgery until the day of discharge from hospital, assessed up to one month.)
  • Bleeding(12 hours after surgery)
  • Mortality(From the day of surgery up to 30 postoperative days)
  • Transfusion(From the day of surgery until the day of discharge from hospital, assessed up to one month.)
  • Major morbidity(From the day of surgery until the day of discharge from hospital, assessed up to one month.)
  • Hospital stay(From the day of surgery until the day of discharge from hospital, assessed up to one month.)

研究者

发起方
Polychronis Antonitsis
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Polychronis Antonitsis

Associate Professor of Cardiac Surgery

Aristotle University Of Thessaloniki

研究点 (2)

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