Haemostasis Management of Patients Undergoing Abdominal Aortic Procedures Associated With High Bleeding Risk
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- The number of blood products used
研究概览
简要总结
Comparative study on efficacy of haemostatic therapy guided either by standard laboratory coagulation parameters or point-of-care testing in patients undergoing vascular surgical procedures. We investigate the amount of perioperative bleeding and the number of blood product used.
Inclusion criteria Patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care, they must be at least 18 years of age and written informed consent was obtained from the patient or his/her legal representative.
Randomisation technique Patients will be randomly assigned to each of two treatment groups using sealed envelopes. In group 1 (G1) haemostasis strategy guided by conventional coagulation tests, while in group 2 (G2) transfusion algorithms guided by point-of-care (POC) tests will be carried out.
Sampling techniques and measurements
For assessment of monitored parameters shall be used arterial or venous blood depending on the catheter placed preoperatively. In case of the above mentioned vascular surgical procedures, all patients will receive arterial cannula routinely, and, depending on the extension of procedure, as appropriate, a central venous catheter will be inserted as well. Sampling in the patient groups shall be performed as follows:
- pre- and postoperative evaluation of standard laboratory parameters in all patients
- evaluation of standard laboratory parameters and arterial Astrup test during and after surgery in group 1, if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes
- in case of elective surgery: thromboelastometry and arterial Astrup test during and after surgery in group 2 if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes
- in case of acute surgery: thromboelastometry and arterial Astrup test before, during and after surgery in group 2
- in case of positive anamnesis, preoperative platelet aggregation test in both groups Besides the above samplings, routine lab tests (blood gas, blood count, sodium (Na), potassium (K), parameters of renal and liver function, clotting and inflammation, lactic acid, blood sugar) will be performed every day as usual during intensive therapy.
详细描述
Despite the fact that interventional therapy of vascular lesions (endovascular and hybrid procedures) is becoming more and more common, angioplasties involving major vessels have to be still managed as surgical procedures associated with extreme high demand for transfusion, this applies especially to acute rupture of aortic aneurysm, aortic dissection, aortobifemoral bypass and certain elective procedures where conventional open surgery is the only therapeutic option. Due the generalised atherosclerosis typical for most vascular surgical patients as well as the vulnerability of vessel wall, major blood loss has to be taken in account even during elective surgeries with minimally invasive techniques. In the event that excessive bleeding would occur, conversion to open surgery may be necessary, for this reason the preparation and perioperative care of patients undergoing interventional surgery have to be performed in the same manner as its is prescribed for open aorta operations.
The bleeding risk associated with the above surgical procedures is increased by the fact that the majority of patients affected are on a single or in some cases on double antiplatelet therapy, and/or receive prolonged anticoagulation treatment. Discontinuation of the treatments is expensive and, in case of indication for acute surgery, may not always be carried out.
Previous bleeding history, current drug therapy, evaluation of coagulation status (prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen) and blood count screening using conventional laboratory tests are part of preoperative preparations. Control of platelet function is always indicated in case of positive anamnesis (inherited or acquired thrombocytopathy, anamnestic information on bleeding complication, skin symptoms suggesting haemophilia), but is not performed routinely. Preoperative normalization of possible abnormalities as well as optimalization of drugs affecting haemostasis, so the reduction of bleeding risk to the minimum are of essential importance, however, we do not always have enough time for it. In cardiovascular surgery, withdrawal of aspirin and/or clopidogrel therapy increases the risk of thrombosis; continuation of aspirin and/or clopidogrel therapy increases the risk of bleeding. In our own practice, in case of elective vascular surgical procedures, aspirin therapy will be continued, but clopidogrel will be stopped 5-7 days prior to surgery, according to the European recommendations. When a patient with prolonged anticoagulant therapy is at high risk for embolism, his medication will be switched to low molecular weight heparin. In case the surgery is performed under ongoing antiplatelet therapy, transfusion of thrombocyte concentrate may also be necessary.
In the European guidelines, the application of transfusion algorithms and protocols incorporating predefined intervention triggers to guide haemostatic intervention during preoperative bleeding are recommended, as well as viscoelastic point-of-care tests (POCT). In lack of the latter, the Hungarian recommendation suggests the application of conventional monitoring assays, however, they give an poor assessment picture with associated with significant time delay, therefore have to be considered inadequate in case of excessive bleeding.
At first, it has to be definitely cleared whether the blood loss is caused by haemostatic or surgical source. In the meantime, however, maintenance of normothermia, prevention of acidosis and normalisation of ionized calcium level are of significant importance. In case of active bleeding the targeted value of systolic blood pressure is 80-100 mmHg, that of haemoglobin concentration 7-9 g/dl. The restrictive transfusion strategy is aimed at decreasing the number of allogeneic transfusions which are regarded as a form of tissue transplantation to the possible minimum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care
- •they must be at least 18 years of age
- •written informed consent was obtained from the patient or his/her legal representative.
排除标准
- •patients under 18 years of age
- •informed consent not provided
- •congenital coagulation factor deficiency
- •congenital thrombocytopathy
研究组 & 干预措施
Conventional group
In the conventional group (group 1) haemostasis strategy guided by conventional coagulation tests will be carried out.
干预措施: Coagulation tests (Diagnostic Test)
Point of care group
In the point of care group (group 2) transfusion algorithms guided by point-of-care (POC) tests will be applied. We will use viscoelastic thromboelastometry and impedance aggregometry.
干预措施: Coagulation tests (Diagnostic Test)
结局指标
主要结局
The number of blood products used
时间窗: 24 hours
Amount of perioperative bleeding
时间窗: 24 hours
次要结局
未报告次要终点
