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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

ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII

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.

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.

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

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

variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery

variations in maximum clotting firmness of ROTEM 48 hours post surgery

variations in COL-EPI (platelet function) from of 48 hours post surgery

variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery

variations in von Willebrand Concentration from 48 hours post surgery

number of packed red blood cells and percentage of transfused patients

Hospitales Universitarios Virgen del Rocío

Critical Care Staff

Thrombosis

Thromboembolism

Embolism

Embolism and Thrombosis

Thrombophilia, blood count and coagulation count

Blood sample analysis

The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.

These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.

In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.

Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients.

Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.

In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.

Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).

In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system.

The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.

These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.

In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.

Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.

Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.

Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.

In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.

Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).

In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system, that is to say:

* The presence of any anti-coagulant or antiplatelet treatment,
* Or abnormalities of primary or secondary hemostasis causing coagulation disorders.

Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.

Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.

Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.

In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.

Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists (AVK), anti platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).

In this study the investigator mean by hypocoagulability any situation modifying the normal coagulation system, that is to say:

* the presence of any anti-coagulant or antiplatelet treatment,
* or abnormalities of primary or secondary hemostasis causing coagulation disorders.

THrombo-Embolic Event in Onco-hematology

"Prospective Study Evaluating the Impact and Treatment of Thrombo-embolic Events in Patients With Cancer"

Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized

These patients in these two situations, will be identified, during the onset of thrombosis, the results of the parameters of their blood count and their intake of antiaggregant or anticoagulant treatment.

• Comparison between the hypocoagulable patient group and the non-hypocoagulable patient group of the biological parameters of the thrombophilia balance, blood counts and coagulation counts in patients with cancer at the time of the occurrence of thrombosis

o The state of hypocoagulability is defined by: thrombocytopenia \<100000 / mm3, abnormality of one or more coagulation factors, platelet antiaggregant treatment, anticoagulant treatment of all kinds.

Incidence rate of first occurrence of thromboembolic events in patients with cancer, and treatment with new oral anticoagulants

Survival at 12 months. 12-month survival is defined as the delay between the date of inclusion and the date of death from all causes. Patients lost to follow-up will be censored on the date of the latest news. Patients will be followed for 12 months after inclusion in the study.

Death rate due to thrombosis is the number of deaths whose cause is thrombosis.

Rate of haemorrhagic complications defined by the number of haemorrhagic events, whatever the degree of severity, of biological or medicinal origin.

o A haemorrhagic event is defined as the occurrence of bleeding by rupture of a blood vessel or effusion out of a blood vessel. Bleeding may be internal or external, see the examples provided below: Internal haemorrhage: cerebral hematoma, subdural hematoma; intramuscular hematoma

- Externalized hemorrhage: epistaxis, gingivorrhagia, externalized digestive bleeding

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC)	NCT03956836	Coagulation Dis... Carcinomatosis	ROTEM parameter...	18 Years -	Hospitales Universitarios Virgen del Rocío
Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC)	NCT03956836	Coagulation Dis... Carcinomatosis	ROTEM parameter...	18 Years -	Hospitales Universitarios Virgen del Rocío
THrombo-Embolic Event in Onco-hematology	NCT03826043	Neoplasms Thrombosis Coagulation Dis...	Blood sample an...	18 Years -	Centre Antoine Lacassagne
THrombo-Embolic Event in Onco-hematology	NCT03826043	Neoplasms Thrombosis Coagulation Dis...	Blood sample an...	18 Years -	Centre Antoine Lacassagne

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