Open Label Use Of RiaStap During Aortic Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Fibrinogen Level Change
研究概览
简要总结
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
详细描述
Study design Open-label study Inclusion criteria Elective, adult aortic reconstruction involving a hemi-arch replacement at Duke University Medical Center (DUMC).
Exclusion criteria Concomitant procedures such as Coronary Artery Bypass Grafting (CABG) , stents (within the last 3 years), refusal of blood transfusion, recent Myocardial Infarction (MI) (within the last 3 months), pregnancy, INR > 1.1, platelet inhibitor drugs within 5 days of surgery (aspirin 325 mg within 48 hours of surgery), platelet count < 150,000, age <18 years, inability to obtain written informed consent, known coagulopathy including a history of recent coumadin therapy.
Primary outcome variable Fibrinogen level Secondary outcome variables Total blood product units administered during post op day (POD) 0, 1, 2, 12 and 24 hour chest tube drainage, ventilator time, duration of oxygen dependency, renal dysfunction. Adverse events will be recorded.
Study procedure The administration of RiaSTAP is detailed in the flowchart below.
Projected milestones Based on recent surgical volume and assuming a conservative recruitment in the 60-70% range we will plan to complete the study of 22 patients as determined by budgetary constraints in a projected 12-month study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Elective, adult aortic reconstruction involving a hemi-arch replacement at DUMC.
排除标准
- •Concomitant procedures such as CABG , stents (within the last 3 years), refusal of blood transfusion, recent MI (within the last 3 months), pregnancy, INR > 1.1, platelet inhibitor drugs within 5 days of surgery (aspirin 325 mg within 48 hours of surgery), platelet count < 150,000, age <18 years, inability to obtain written informed consent, known coagulopathy including a history of recent coumadin therapy.
研究组 & 干预措施
RiaSTAP
One time dose of 70 mg/kg will be administered intravenously.
干预措施: RiaSTAP (Drug)
结局指标
主要结局
Fibrinogen Level Change
时间窗: Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)
Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.
次要结局
- Packed Red Blood Cell Transfusion(Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline))
- Fresh Frozen Plasma Transfusion(Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline))
- Cryoprecipitate Transfusion(Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline))
- Platelet Transfusion(Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline))