THrombo-Embolic Event in Onco-hematology

Neoplasms Clinical Trial

— THEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826043
• Other study ID #: 2018/23
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: September 9, 2022

Study information

• Verified date: April 2022
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient followed for CAL cancer and admitted to the LTC in the Medicine Department.

2. Age> to 18 years.

3. Patient having read the information note and signed the informed consent (including specific consent for genotyping of clotting factors).

4. Patient receiving social insurance.

5. Weight> 50kg

6. Hemoglobin level> 7.0 g / dl

Exclusion Criteria:

1. Patient not benefiting as part of his treatment from hospitalization, but admitted on an ambulatory basis.

2. Patient whose age is less than 18 years.

3. Patient already included in the study.

4. Patient considered a vulnerable person; Vulnerable people are defined in Article L1121-5 to -8:

• Pregnant women, parturients and breastfeeding mothers

• Persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8

• and persons admitted to a health or social institution for purposes other than research

• adults who are legally protected or unable to express their consent

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Neoplasms
• Thromboembolism
• Thrombosis

Intervention

Diagnostic Test:
• Blood sample analysis
Thrombophilia, blood count and coagulation count

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of thrombosis rate in patients hospitalized for cancer	Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized	12 months
Secondary	Comparison of the values of the biological parameters of thrombophilia assessment, blood count and coagulation, at the time of the occurrence of thrombosis, between patients in a situation of hypocoagulability and patients with no hypocoagulability.	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.	12 months
Secondary	Determination of thrombosis rate with new oral anticoagulants.	Incidence rate of first occurrence of thromboembolic events in patients with cancer, and treatment with new oral anticoagulants	12 months
Secondary	Comparison of 12-month survival of patients with or without hypocoagulability, with thrombosis.	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.	12 months
Secondary	• Determination of death rate due to thrombosis.	Death rate due to thrombosis is the number of deaths whose cause is thrombosis.	12 months
Secondary	Determination of the rate of hemorrhagic complications in this population.	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	12 months