THrombo-Embolic Event in Onco-hematology

NCT ID: NCT03826043

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2022-09-09

Brief 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.

Detailed 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.

Conditions

Neoplasms; Thrombosis; Coagulation Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Experimental arm

Hospitalized patient

Group Type: EXPERIMENTAL

Blood sample analysis

Intervention Type: DIAGNOSTIC_TEST

Thrombophilia, blood count and coagulation count

Interventions

Blood sample analysis

Thrombophilia, blood count and coagulation count

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

Other Identifiers

2018-A01120-55

Identifier Type: OTHER

Identifier Source: secondary_id

2018/23

Identifier Type: -

Identifier Source: org_study_id