THrombo-Embolic Event in Onco-hematology

NCT03826043 | Completed DMC

• 2 other identifiers: 2018/232018-A01120-55
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Thrombosis; Coagulation Disorder

Keywords

Neoplasms, Thrombosis, hypocoagulability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  12 months

• Determination of thrombosis rate with new oral anticoagulants.

  12 months

• Comparison of 12-month survival of patients with or without hypocoagulability, with thrombosis.

  12 months

• • Determination of death rate due to thrombosis.

  12 months

• Determination of the rate of hemorrhagic complications in this population.

  12 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Hospitalized patient

Diagnostic Test: Blood sample analysis

Interventions

Blood sample analysis DIAGNOSTIC_TEST

Thrombophilia, blood count and coagulation count

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient followed for CAL cancer and admitted to the LTC in the Medicine Department.
• Age\> to 18 years.
• Patient having read the information note and signed the informed consent (including specific consent for genotyping of clotting factors).
• Patient receiving social insurance.
• Weight\> 50kg
• Hemoglobin level\> 7.0 g / dl

You may not qualify if:

• Patient not benefiting as part of his treatment from hospitalization, but admitted on an ambulatory basis.
• Patient whose age is less than 18 years.
• Patient already included in the study.
• 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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

Neoplasms; Thrombosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: September 9, 2019
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)