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临床试验/NCT03598907
NCT03598907终止不适用

Point-of-care (POC) Approach to Management of Coagulopathy in Lung Transplantation Versus Standard Approach and Their Effect on Primary Graft Dysfunction (PGD), Randomized Controlled Study

University Hospital, Motol1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
100
试验地点
1
主要终点
Perioperative Blood Loss

研究概览

简要总结

Pulmonary transplantation is a very demanding surgical procedure, often accompanied by coagulopathy and severe perioperative bleeding. The most common complication that develops within the first 72 hours after surgery is primary graft dysfunction (PGD), up to 30% in the most severe form. The etiology of PGD is multifactorial. One of the causes may be the amount of perioperative blood loss. Intravascular volume is normally maintained by the administration of crystalloid and colloid solutions and fresh frozen plasma, which is also used to treat coagulopathy, however it is administered at the discretion of the anaesthetist and his experience, practically meaning ,,blindly". In the field of the allogeneous ischemic organ, these substitution solutions essentially become another allogeneous material and can cause undesired immunomodulation and contribute to the development of PGD. In our prospective randomized trial (120 patients), two patient groups will be investigated. In the first group, the coagulopathy and perioperative blood loss will be treated by the current standard approach, by ,,blind" administration of fresh frozen plasma, crystalloids and colloids. In the second group, the cause of coagulopathy will be diagnosed and treated according to the point-of-care (POC) results of ROTEM, PFA 200 and Multiplate. A colloidal solution of 5% albumin will be used to replace the circulating volume and maintain the oncotic pressure. Investigators assume that the POC management of coagulopathy and bleeding in the second group will lead to a reduction in perioperative bleeding, to reduced administration of infusion solutions, and thus to a reduction of the incidence of PGD.

详细描述

Introduction and project description:

Primary graft dysfunction (PGD) in lung transplant patients is described as acute pulmonary damage occurring early in lung transplantation (in the first 72 hours) (1, 2), sometimes referred to as ischemia - reperfusion injury (1). It is characterized by non-cardiac pulmonary edema and diffuse alveolar damage. Clinically, it is manifested by varying degrees of hypoxemia, along with diffuse infiltrates in the X-ray of the lung. There are more theories that try to explain the cause of PGD. A number of factors such as cold organ ischemia, mechanical irritation during organ reperfusion, immunological, inflammatory, microbiological factors, and many others associated with lung transplantation (2, 3) may play a roll. Depending on the severity of the clinical symptoms and the severity of X-ray findings according to International Society of Heart and Lung Transplantation (ISHLT) there are three types of PGD. The incidence of PGD in its worst form (Grade 3) in early post-transplantation period is being reported to be present in up to 30% and between 10-25% within 24-72 hours after organ reperfusion. Lighter forms of PGD (1st and 2nd degree) occur much more frequently (2,3). Lung affected by PGD is characteristically edematous and the gas exchange is significantly impaired due to damage to the endothelial barrier integrity of the vessels and the epithelial barrier of the lung tissue. The presence of PGD significantly increases the morbidity and mortality of patients and significantly prolongs the time spent in invasive mechanical ventilation, generally prolongs the time spent in intensive care unit and is a significant risk factor for development of chronic rejection of the transplanted lung (2,3).

Lung transplantation is a demanding surgical procedure often associated with the development of coagulopathy and significant bleeding, especially when extracorporeal membrane oxygenation (ECMO) is used perioperatively, which is practically used in the most cases. Blood loss is replaced by the administration of crystalloid and colloid solutions in order to maintain normovolemia and by administering FFP, which is also used to treat coagulopathy, despite the fact that the International Normalized Ratio (INR) of blood plasma is 1.5-1.6. These preparations are administered according to the anesthesiologist's experience and practically ,,blindly". However, their administration in patient significantly immunocompromised may mean a risk of immunomodulation and thus a deterioration of PGD. In addition, the administration of blood plasma is generally associated with higher morbidity and mortality of patients (1).

On the other hand, point-of-care (POC) monitoring of the hemocoagulation state using rotational thromboelastometry (ROTEM) and subsequent targeted coagulopathy therapy during the perioperative period and traumatic life threatening bleeding resulted in decreased bleeding intensity and consumption of transfusion products and this approach led to a reduction in morbidity and mortality of these patients (2,3).

Also, methods for evaluating primary haemostasis such as PFA 200 (platelet function analyzer) and aggregometry-Multiplate can be used as POC methods in the operating room, especially for the diagnosis of coagulopathy accompanying the use of ECMO, especially for the diagnosis of von Willebrand's disease (PFA 200) or for the diagnosis of thrombocytopathy (Multiplate) (1-4).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years
  • Indicated for bilateral lung transplantation with diagnosis of interstitial pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, exogenous allergic alveolitis

排除标准

  • Patients requiring plasmapheresis before lung transplantation
  • Patients waiting for lung transplantation on ECMO (ECMO used as bridging to surgery)
  • Patients undergoing simultaneous lung and heart transplantation

结局指标

主要结局

Perioperative Blood Loss

时间窗: From the beginning of surgery to 24 hours postoperatively

Total estimated blood loss measured during the perioperative period of lung transplantation (including intraoperative and immediate postoperative period).

次要结局

未报告次要终点

研究者

发起方
University Hospital, Motol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Durila Miroslav MUDr. Ph.D.

associate professor

University Hospital, Motol

研究点 (1)

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