NCT00823082已完成2 期
A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative ATIII Levels at the ICU Admission
研究概览
简要总结
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •At least 18 years of age
- •Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
- •Subject had a baseline ATIII level of less than 100% and equal to or above 60%
- •Subject signed the informed consent form
- •Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study
排除标准
- •Documented congenital ATIII deficiency or ATIII levels below 60%
- •Subject had a baseline ATIII level of 100% or higher
- •Subject needed emergency (non-elective) surgery
- •Subject needed heart transplantation
- •History of anaphylactic reaction(s) to blood or blood components
- •Allergies to excipients
- •Subject was pregnant
- •Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
- •Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment
- •Subject had participated in any another investigational study within the last 30 days previous to the inclusion
研究组 & 干预措施
Antithrombin III treatment group
Experimental
Preoperative ATIII supplementation administered immediately after anesthesia induction
干预措施: Antithrombin III (Drug)
结局指标
主要结局
Postoperative ATIII Levels at the ICU Admission
时间窗: ICU admission
Measurement of postoperative ATIII functional activity at ICU admission
Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
时间窗: ICU admission
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
次要结局
- Percentage of Subjects With Postoperative Myocardial Infarction(During ICU stay (maximum 70 days))
- Percentage of Subjects With Adverse Neurologic Outcome(During ICU stay (maximum 70 days))
- Percentage of Patients With Thromboembolic Events(During ICU stay (maximum 70 days))
- ICU Stay Duration(During ICU stay (maximum 70 days))
- In-hospital Postoperative Mortality(70 days after ICU admission (maximum))
- Heparin Resistance(Immediately after anesthesia induction)
- Postoperative Blood Loss in First 12 Hours(ICU admission through 12 hours post-operative)
- Need for Blood Products(During ICU stay (maximum 70 days))
- Percentage of Subjects Needing Surgical Re-exploration(During ICU stay (maximum 70 days))
- Percentage of Subjects With Low Cardiac Syndrome(During ICU stay (maximum 70 days))
- Percentage of Subjects With Renal Dysfunction(During ICU stay (maximum 70 days))
- Mechanical Ventilation Duration(During ICU stay (maximum 70 days))
- Length of Hospital Stay(During ICU stay (maximum 70 days))
研究者
研究点 (1)
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