Clinical trial NCT03956836: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Carcinomatosis
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of peritoneal surface malignancy of the ovarian and/or colo origin undergoing complete cytoreductive surgery (zero) combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

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.

Eligibility criteria: 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. - Exclusion criteria: were severe cardiovascular or respiratory disease,
2. - Lower hemoglobin than 10,0 g/dL , platelet count 100,000/mm3,
3. - Renal or hepatic failure,
4. - Pregnancy,
5. - Multiple partial intestinal obstruction or extensive involvement of the surface of the small bowel as well as distant and non-resectable metastases.

Primary outcomes:
measure: Variations of CT-ROTEM
timeFrame: 48 hours
measure: Variations of MCF-ROTEM
timeFrame: 48 hours
measure: Variations of PFA-100
timeFrame: 48 hours
measure: Variations of Factor XIII
timeFrame: 48 hours
measure: Variations of von Willebrand
timeFrame: 48 hours
Secondary outcomes:
measure: Transfusion of red blood cells
timeFrame: 20 days
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucia
Study officials:
References: