Impact of Anticoagulation Management on Thrombin Generation During Surgery for Acute Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- F1+2
研究概览
简要总结
Acute aortic dissection (AAD) involving the ascending aorta (Stanford classification type A) remains a life-threatening disease. Excessive perioperative bleeding requiring massive transfusion of allogeneic blood products, and surgical reexploration remain major challenges in these patients. Previous research has indicated that patients with AAD show pronounced haemostatic alterations prior to surgery which are aggravated during major aortic surgery with cardiopulmonary bypass and hypothermia full heparinization.
Intensified anticoagulation management guided by heparin dose response (HDR) calculation, and repeated measurement of heparin concentration may be more effective than standard empiric weight-based heparin and protamine management monitored by activated clotting time (ACT) measurements to suppress thrombin generation during surgery for AAD.
This randomized controlled clinical trial compares the impact of two recommended anticoagulation management strategies during surgery for AAD including deep hypothermia on activation of coagulation: Heparin/protamine-management based on HDR-titration by means of HMS Plus® versus current institutional standard (HDR- versus ACT-approach).
Primary endpoint is thrombin generation as measured by early postoperative prothrombin fragment 1+2 (F1+2). Secondary endpoints are other markers of coagulation and fibrinolysis as well as clinical outcome.
详细描述
Hypotheses:
Primary: HDR-approach is superior to ACT-approach in terms of suppressing thrombin generation after emergent surgery for acute aortic dissection (Stanford type A).
Secondary: HDR-approach is superior with regard to
- early postoperative haemostatic capacity
- requirement of blood product transfusion and haemostatic agents
- postoperative bleeding
Design:
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, Outcomes Assessor)
盲法说明
Treatment group allocation cannot be concealed for the operating team, but participants, other members of the treatment team, laboratory personnel and other practitioners administering postoperative care as well as outcome assessors will be blinded regarding the allocation.
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
- •Age > 18 years
- •Emergent Acute Aortic Dissection with cardiopulmonary bypass
- •Incapable of providing informed consent
排除标准
- •History of congenital coagulation disorder (haemophilia)
- •Previous open cardiac surgery
- •Death during induction of anaesthesia
结局指标
主要结局
F1+2
时间窗: up to 2 days after surgery
Prothrombin fragment 1+2 (pmol/L)
次要结局
- Resistance(immediately after surgery)
- Fibrinogen(24 hours after surgery)
- Cryoprecipitate Plasma(24 hours after surgery)
- Recombinant FVIIa(24 hours after surgery)
- Reoperation for bleeding(30 days after surgery)
- Stroke(30 days after surgery)
- Length of surgery(30 days after surgery)
- TAT(up to 2 days after surgery)
- Heparin (total)(immediately after surgery)
- Blood cell-saver(immediately after surgery)
- Drain output(48 hours after surgery)
- Protocol violation(immediately after surgery)
- Length of stay ICU(30 days after surgery)
- ETP(up to 2 days after surgery)
- Antithrombin(up to 2 days after surgery)
- D-dimer(up to 2 days after surgery)
- 2. Closure(30 days after surgery)
- Renal(30 days after surgery)
- Length of hospitalization(30 days after surgery)
- Thrombin time(up to 2 days after surgery)
- Clot lysis(up to 2 days after surgery)
- Heparin sensitivity(prior to surgery)
- Ratio(immediately after surgery)
- Blood loss sponges(immediately after surgery)
- Blood tranfusion(48 hours after surgery)
- PCC(24 hours after surgery)
- AT concentrate(24 hours after surgery)
- Protamin (total)(immediately after surgery)
- Mortality(up to 90 days after surgery)
- Myocardial infarction(30 days after surgery)
- Low cardiac output syndrome(30 days after surgery)
- Vascular malperfusion(30 days after surgery)
- Intraop. coagulation(Immediately after surgery)
研究者
Ivy susanne Modrau, MD
Dr. Med., Consultant Cardiac Surgeon, Associate Professor
Aarhus University Hospital Skejby