The Use of Fibrinogen Concentrate in High-Risk Cardiac Surgery. A Prospective, Double-blinded, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Cumulative Transfusion Units
研究概览
简要总结
The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.
详细描述
All patients will be recruited from the Queen Elizabeth II (QEII) Health Sciences Center, Halifax, Nova Scotia, which is the sole tertiary cardiac surgical referral center in Nova Scotia that performs approximately 1000 open heart surgical procedures yearly, including more than 700 isolated coronary artery bypass graft (CABG) procedures.
Inclusion criteria: All patients who are scheduled for elective complex cardiac surgical procedures including, double procedures (aortic valve replacement+coronary artery bypass graft , mitral valve replacement+coronary artery bypass graft , aortic valve replacement+mitral valve replacement), redo-sternotomies, and aortic root repair +/-aortic valve replacement.
Exclusion criteria: Any known congenital or preexisting bleeding disorder, preexisting clinically significant abnormal fibrinogen level, severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l), inability of providing informed consent, emergency surgery, pregnancy or nursing, age under 18 years, intake of anti-platelet drugs within the last 2- 5 days before surgery (low dose aspirin is allowed) allergy to concentrated fibrinogen or other components in the product, anemia (Hb < 110), diagnosed deep venous thrombosis, pulmonary embolism, acute stroke or acute myocardial infarction.
The primary outcome: Cumulative perioperative amount (number of units and total volume) of blood components used between the start of surgery and 24 hours after administration of the study drug or placebo. 'Blood Components' are defined as all fresh components of blood (RBCs, plasma, platelets, and Cryo).
The secondary outcomes: Fibrinogen levels, hematocrit, prothrombin time (PT), partial prothrombin time (PTT), INR, platelet count, Hemoglobin (Hb), Thromboelastometry (ROTEM®, clotting time (CT), clot formation time (CFT), Angle, maximum clot firmness (MCF), Cardiovascular intensive care unit (CVICU-stay), Hospital-stay, In-Hospital Mortality, Hemoglobin, adverse events (anaphylaxis, stroke, myocardial infarction, pulmonary embolism, and deep vein thromboembolism) and usage of factor VII concentrate and human prothrombin complex (factors II, VII,IX, X), total avoidance of transfusion after cardiopulmonary bypass (CPB) 24h after administration of study drug or placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All patients who are scheduled for elective complex cardiac surgical procedures including
- •double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
- •Redo-sternotomies
- •Aortic root repair +/- AVR
排除标准
- •Any known congenital or pre-existing bleeding disorder
- •pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
- •severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
- •inability to provide informed consent
- •emergency surgery
- •pregnancy or nursing
- •age under 18 years
- •intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
- •allergy to concentrated fibrinogen or other components in the product
- •anemia (Hgb < 110)
- •diagnosed deep vein thrombosis (DVT)
- •pulmonary embolism
- •acute stroke
- •acute myocardial infarction
研究组 & 干预措施
RiaSTAP
Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula
干预措施: Fibrinogen (Drug)
Intravenous saline
Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula
干预措施: Fibrinogen (Drug)
结局指标
主要结局
Cumulative Transfusion Units
时间窗: 24 hours after administration of study drug
Including packed red cells, frozen plasma, platelets, cryoprecipitates
次要结局
- Platelet Count (10^3/μL)(24h after infusion of study drug)
- Fibrinogen Plasma Concentration (g/L)(24h after infusion of study drug)
- INTEM Maximum Clot Firmness (mm)(24h after infusion of study drug)
- FIBTEM Clotting Time (s)(24h after infusion of study drug)
- Hematocrit (%)(24h after infusion of study drug)
- Partial Thromboplastin Time (s)(24h after infusion of study drug)
- EXTEM Maximum Clot Firmness (mm)(24h after infusion of study drug)
- INTEM Clotting Time (s)(24h after infusion of study drug)
- Hemoglobin Concentration (g/L)(24h after infusion of study drug)
- EXTEM Clotting Time (s)(24h after infusion of study drug)
- FIBTEM MCF (Maximum Clot Firmness)(24 hours after study drug administration)
- International Normalized Ratio(24h after infusion of study drug)
- Prothrombin Time (s)(24h after infusion of study drug)
- HEPTEM Maximum Clot Firmness (mm)(24h after infusion of study drug)
- Total Avoidance of Transfusions(24h after infusion of study drug)
- HEPTEM Clotting Time (s)(24h after infusion of study drug)
研究者
Myron Kwapisz, MD
MD
Nova Scotia Health Authority