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Spots Global Cancer Trial Database for Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC)

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Trial Identification

Brief Title: Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC)

Official Title: Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Study ID: NCT03956836

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Universitario Virgen del Rocio, Sevilla, Andalucia, Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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