Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Venous Thromboembolism; Cancer

Treatments: Other: data collection

Study type: Observational

Funder types: Other

Identifiers

NCT04846556

IRBN352021/CHUSTE

Details and patient eligibility

About

Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.

Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.

However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.

Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.

The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.

Full description

The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Consecutive patients with a newly diagnosed, objectively confirmed:

• symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
• symptomatic or unsuspected Pulmonary Embolism (PE)

Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:

• Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
• Cancer diagnosed within 2 years.

Exclusion criteria

• pregnant women or breast feeding

Trial design

300 participants in 1 patient group

venous thromboembolic event related to cancer

Description:

Patients admitted for a venous thromboembolic event related to their cancer will be included A data collection will be realized. Patients admitted between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.

Treatment:

Other: data collection