The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluate the total bleeding up to 48 hours of the operation.
研究概览
简要总结
SASH Trial is a multicenter, prospective, open and randomized 1:1 study. The aim of this study is to evaluate the efficacy of TDM-621(Three-D Matrix- 621) (PuraStat®) on hemostasis of ascending aortic surgery. The TDM-621 is a topic hemostatic product. When in contact with blood it allowed to cover the sutures improving the hemostasis. The hypothesis is that the use of TDM-621 may reduce bleeding and the need for blood transfusion of patients undergoing ascending aortic surgeries. It will include 200 consecutive patients randomized to receive TDM-621 or regular procedure, performed in 5 different centers.
详细描述
According to data from the National Center for Health Statistics 2013, more than 51 million surgical procedures with hospitalized patients are conducted annually in the United States. During and postoperative bleeding is a concern for increasing the morbidity and mortality of the procedures, in addition to being sometimes associated with the need for reoperation.
During surgery as the earlier hemostasis is achieved, the shorter time of operation, the less need for transfusion, the better is the handling of the patient and the earlier their recovery. Therefore, the shorter is the length of stay in the intensive care unit and the hospitalization, which will result in a reduced costs.
In cardiovascular surgery, especially in aortic operations, whose surgical procedure requires anticoagulation with heparin, cardiopulmonary bypass, several degrees of hypothermia, sometimes systemic circulatory arrest, among other tactics in the operative handling, all the additional resources that may help in the hemostasis are vital to improve the outcomes.
Hemostats or adhesives derived from collagen or hydrogels are products that have been developed to contain minor, less intense bleeds and act as a barrier of containment when placed on a bloody surface that in contact with the blood, would help in the formation of the clot. The sealants are basically divided into the fibrin glues (human or animal origin), products that mimic the final pathway of the coagulation cascade in the formation of the fibrin clot. Also there are the synthetic sealants (polyethylene glycol polymers) that form an adhesive over the applied site.
TDM-621 (PuraStat® component) is an absorbable, local hemostatic agent composed of nanofibers of a self-supporting polypeptide that forms a hydrogel that, when in contact with blood, allows the suture vessel wall to be optimized for hemostasis.
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
- 否
入选标准
- •Patient must be over 18 years old,
- •Patient with aortic root aneurysm and / or ascending aorta, or chronic Stanford A dissections whose surgical correction is restricted to the root, ascending aorta and extending distally up to the hemiarch , including reoperations,
- •All procedures on the aortic valve and coronary ostia are allowed,
- •All patients will be clarified on the details of the study and if they agree to participate, they will sign the informed consent form.
排除标准
- •Patients with acute aortic dissection,
- •Patients whose correction includes total replacement of the aortic arch or distal extension to it,
- •Patients who require associated procedures on the other cardiac valves other than the aortic valve,
- •Patients who require myocardial revascularization,
- •Patients who refuse to receive blood products,
- •Patients with chronic anemia (hemoglobin less than 12g / dl for women and 13g / dl for men),
- •Platelet count less than 150,000 / mm3,
- •Coagulopathy (previous history, use of anticoagulants not reversed, prothrombin time higher than 14.8 seconds or INR (international normalized ratio) higher than 1.2), hypofibrinogenemia (fibrinogen less than or equal to 150mg / dl),
- •Patients in uninterrupted use of antiplatelet therapy (less than 7 days of operation), inhibitors of glycoproteins IIb / IIIa, as well as some supplements or vitamins (ginger, ginkgo biloba or fish oil),
- •Patients with terminal liver disease, renal dialysis and neoplasias.
研究组 & 干预措施
Control
This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques.
TDM-621
This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques and will receive the TDM-621 for complementary hemostasis.
干预措施: TDM-621 (Combination Product)
结局指标
主要结局
Evaluate the total bleeding up to 48 hours of the operation.
时间窗: Total blood volume measured up to 48hours after surgery.
This evaluation will be made by measuring the wet weight of the compresses after infusion of protamine until the closure of the chest, also by measuring the volume of red cells recovered by the cell saver and through the flow of the mediastinum drain in the first 6hours, 12hours, 24hours and 48hours of the postoperative period initiated after the sternum closure.
Evaluate the number of bags of red blood cells transfused up to 48 hours of the operation.
时间窗: Total amount of red cells bags up to 48hours postoperative period.
This outcome will be evaluated by quantifying the number of bags of red blood cells needed, following the study criteria, during the operation until 48 hours after the postoperative period.
次要结局
- To evaluate the transfusion of platelet concentrate, or cryoprecipitates or fresh frozen plasma received intraoperatively up to 48 hours after the end of the procedure.(Total number of bags of any component from intraoperative up to 48hours postoperative period.)
- Evaluation of postoperative complications.(From the postoperative time up to 48 hours.)
- In hospital mortality(From the postoperative time until the date of death from any cause or date of hospital discharge whichever came first up to 2 weeks.)
研究者
Ricardo Ribeiro Dias
Principal Investigator
University of Sao Paulo General Hospital