Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41012, Spain
NCT Number: NCT03956836
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.
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All sexes
Observational
Seville, Andalusia, 41012, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: ROTEM, PFA-100
Time frame: 48 hours
variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery
Time frame: 48 hours
variations in maximum clotting firmness of ROTEM 48 hours post surgery
Time frame: 48 hours
variations in COL-EPI (platelet function) from of 48 hours post surgery
Time frame: 48 hours
variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery
Time frame: 48 hours
variations in von Willebrand Concentration from 48 hours post surgery
Time frame: 20 days
number of packed red blood cells and percentage of transfused patients
Hospitales Universitarios Virgen del Rocío
Other
Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Acronym: HIPEC-COAG
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