Pilot Clinical Trial of Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen (INTERCEPT Fibrinogen Complex) in Patients With Bleeding to Expedite Product Availability and Improve Outcomes in Perioperative Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Total Number of RBCs Used Over Admission
研究概览
简要总结
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.
Participants will be given one of the two FDA-approved blood products.
详细描述
Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
- •Cardiovascular surgery includes the following procedures:
- •coronary artery bypass grafting
- •valve repair or replacement
- •open thoracic aortic and thoracoabdominal aortic surgery
- •atrial or ventricular septal defects
- •ventricular assist device implantation or revision
- •or any combination of the above.
排除标准
- •Patients who do not receive any cryo product in the OR
- •Patients who are not cardiovascular surgery or liver transplant patients
- •Cardiac transplantation surgery
- •Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month.
- •Patients who receive less than 1 pool (5 units) of cryo
- •Pediatric patients (less than 18 years of age).
- •Patients who received both PR cryo and traditional cryo
- •Pregnant women
研究组 & 干预措施
Patients given Traditional Cryo
These are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.
干预措施: Traditional Cryoprecipitate (Biological)
Patients given PR Cryo
These are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.
干预措施: Pathogen-Reduced Cryoprecipitate (Biological)
结局指标
主要结局
Total Number of RBCs Used Over Admission
时间窗: Within the first 30 days after surgery.
RBCs used over admission
Total Number of Platelets Used Over Admission
时间窗: Within the first 30 days after surgery.
Plts used over admission
Total Number of Plasma Used Over Admission
时间窗: Within the first 30 days after surgery.
All units over admission
次要结局
- Number of Cryo Units Used Perioperatively(3 days post procedure)
- Number of RBCs Used Perioperatively(3 days post procedure)
- Number of Plasma Used Perioperatively(3 days post procedure)
- Number of Platelets Used Perioperatively(3 days post procedure)
- Time From Operating Room (OR) Start Time to Start of Cryo Transfusion(procedure (Time from OR start time to start of cryo transfusion))
- Time From Cryo Order to Start of Transfusion(procedure (Time from cryo order to start of transfusion))
- Number of Cryo Units Wasted by Blood Bank(Daily, up to approximately 24 months)
- Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation(Variable, but it is generally available within 15 minutes of the start of ROTEM testing.)
- Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation(Variable, but it is generally available within 15 minutes of the start of ROTEM testing.)
- Maximum Clot Firmness (MCF)(Variable, but it is generally available within 1 hour of the start of ROTEM testing.)
- Pre-transfusion Fibrinogen Level(During surgery, within 3 hours of specimen receipt by laboratory.)
- Highest Fibrinogen Level Within 24 Hours(Within 24 hours after surgery)
- Lowest Fibrinogen Level Within 24 Hours(Within 24 hours after surgery)
- Volume in Drains (Chest Tube for CV Surgery)(At 24 hours after surgery)
- Time From End of Bypass Pump for CV Surgery(Until end of surgery)
- Length of Stay in ICU(During hospitalization, approximately 5 days to 30 days)
- Number of Participants That Experienced an Adverse Event of Transfusion Reaction.(Within 5 days of surgery start time)
- Fibrinogen Level(Most proximal to end of procedure)
- Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal(Up to approximately 3 days)
- Length of Stay in OR(Duration of time in operating room)
- Length of Stay in Hospital(During hospitalization, approximately 5 days to 30 days)
- Need for Ventilator(During hospitalization, approximately 5 days to 30 days)
- Time on Ventilator(During hospitalization, approximately 5 days to 30 days)
- Overall Cost of Cryo vs PR Cryo, When Factoring Wastage(Daily, approximately 24 months)
- Number of Participants That Experienced an Adverse Event of Fever(Within 5 days of surgery start time)
- Number of Participants That Experienced an Adverse Event of Infection(Within 5 days of surgery start time)