Carcinomatosis, Coagulation Disorder
Conditions
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.
Interventions
DIAGNOSTIC_TESTROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII
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
Sponsors
Hospitales Universitarios Virgen del Rocío
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \- Consecutive patients with peritoneal surface malignancy treated with cytoreductive surgery and HIPEC in the Department of Surgery of Virgen del Rocio General Hospital 2. -All patients gave written informed consent. 3. -Age above 18 years and Karnofsky performance status scale 450%
Exclusion criteria
1. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variations of CT-ROTEM | 48 hours | variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery |
| Variations of MCF-ROTEM | 48 hours | variations in maximum clotting firmness of ROTEM 48 hours post surgery |
| Variations of PFA-100 | 48 hours | variations in COL-EPI (platelet function) from of 48 hours post surgery |
| Variations of Factor XIII | 48 hours | variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery |
| Variations of von Willebrand | 48 hours | variations in von Willebrand Concentration from 48 hours post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion of red blood cells | 20 days | number of packed red blood cells and percentage of transfused patients |
Countries
Spain
Outcome results
None listed