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

Completed

• Conditions: Venous Thromboembolism; Cancer
• Interventions: Other: data collection

• Registration Number: NCT04846556
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-15
• Study Start: 2022-04-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
venous thromboembolic event related to cancer	data collection	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.

Primary Outcome Measures

Name	Time	Method
Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study	Up to 6 months after venous thromboembolic event	Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) : * ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV; * life expectancy of less than 6 months; * thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; * indication for anticoagulant treatment for a disease other than the index VTE episode; * thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; * recent brain, spinal or ophthalmic surgery; * hemoglobin level lower than 8 g/dL or platelet count \<75x10\^9/L or history of heparin induced thrombocytopenia; * creatinine clearance \< 30 ml /min; * acute hepatitis, chronic active hepatitis, liver cirrhosis; * uncontrolled hypertension; * concomitant use of strong inhibitors or inducers of cytochrome; * bacterial endocarditis;

Secondary Outcome Measures

Name	Time	Method
Confirmed recurrent Venous Thromboembolic Event (VTE)	Up to 6 months after venous thromboembolic event	Collected in medical history.; * Pulmonary embolism; * deep venous thrombosis
Death	Up to 6 months after venous thromboembolic event	Collected in medical history.
Drugs used for their VTE	Up to 6 months after venous thromboembolic event	Collected in medical history.
Bleeding event	Up to 6 months after venous thromboembolic event	Collected in medical history.

Trial Locations

Locations (3)

CHU d'Amiens; 🇫🇷 Amiens, France

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France

Hôpital Louis Mourier; 🇫🇷 Colombes, France