Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Variations of MCF-ROTEM
研究概览
简要总结
Cytoreductive surgery (CRC) with intraperitoneal hyperthermal chemotherapy (HIPEC) has been shown to improve survival in selected patients with peritoneal carcinomatosis. 51% of patients are transfused due to the high intraoperative blood loss caused by surgery and the appearance of a perioperative coagulopathy attributed to the loss of proteins into the peritoneal cavity, the high fluid turnover and possibly the action of hyperthermic chemotherapy. So far, the haemostatic changes described consist of a decrease in the levels of antithrombin III and the platelet count, as well as in alterations of the usual coagulation tests. Conventional coagulation tests analyze only the plasmatic phase of coagulation while viscoelastic tests, such as rotational thromboelastometry (ROTEM), reproduce the global coagulation process much more faithfully, keeping good correlation with perioperative bleeding.
Objetive:
The platelet, coagulation, von Willebrand and Factor XIII levels and function have not been consistently investigate in pre-established (fix) time periods in patients undergoing elective CRC with hyperthermia. This prospective observational study aimed at investigating the variations of the values of estándar coagulation test, ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC. A control group (N=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.
详细描述
This prospective observational study aimed at investigating the variations of the values of estándar coagulation test, ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC. A control group (N=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Consecutive patients with peritoneal surface malignancy treated with cytoreductive surgery and HIPEC in the Department of Surgery of Virgen del Rocio General Hospital
- •All patients gave written informed consent.
- •Age above 18 years and Karnofsky performance status scale 450%
排除标准
- •Exclusion criteria: were severe cardiovascular or respiratory disease,
- •Lower hemoglobin than 10,0 g/dL , platelet count 100,000/mm3,
- •Renal or hepatic failure,
- •Pregnancy,
- •Multiple partial intestinal obstruction or extensive involvement of the surface of the small bowel as well as distant and non-resectable metastases.
结局指标
主要结局
Variations of MCF-ROTEM
时间窗: 48 hours
variations in maximum clotting firmness of ROTEM 48 hours post surgery
Variations of von Willebrand
时间窗: 48 hours
variations in von Willebrand Concentration from 48 hours post surgery
Variations of CT-ROTEM
时间窗: 48 hours
variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery
Variations of PFA-100
时间窗: 48 hours
variations in COL-EPI (platelet function) from of 48 hours post surgery
Variations of Factor XIII
时间窗: 48 hours
variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery
次要结局
- Transfusion of red blood cells(20 days)
研究者
Antonio M. Puppo Moreno
Critical Care Staff
Hospitales Universitarios Virgen del Rocío