Recurrence and Bleeding in Colorectal Cancer Patients With Cancer-associated Venous Thrombembolism

Sun Yat-sen University

Status: Completed

Conditions: Thrombosis, Venous; Colo-rectal Cancer; Bleeding

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT06440044

2024ZSLYEC-226

Details and patient eligibility

About

Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Patients with CRC are underrepresented in the major trials examining treatment of cancer-associated VTE with anticoagulant.

Full description

Patients with colorectal cancer (CRC) have a higher risk of both venous thromboembolism (VTE) and major bleeding (MB). Specifically, a subsequent analysis of the Hokusai study showed that the excess in MB was confined to patients with gastrointestinal cancer. In the RIETE registry, patients with gastrointestinal or genitourinary cancers experienced more bleeding outcomes while patients with brain or lung cancer experienced more thrombotic outcomes. However, in a subgroup analysis of the Caravaggio trial, major gastrointestinal bleeding in patients with CRC was low and similar in both apixaban and LMWH groups. Patients with CRC are underrepresented in the major trials examining treatment of CAT with anticoagulant. Despite concerns that DOACs pose a significant bleeding risk in CRC patients, many patients with CRC are treated with apixaban or rivaroxaban in clinical practice. Balancing risks of thrombosis recurrence and bleeding can be challenging and requires a nuanced, individualized approach to decision making to improve prognosis in this population. The aim of this study is to identify risk factors for recurrence and bleeding in CRC patients with VTE. Deaths, regardless of the mechanism, will also be included in the one year all-cause mortality outcome.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment.
2. CRC patients with VTE treated with an anticoagulant (rivaroxaban or LMWH) for at least six months.

Exclusion criteria

1. Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.

Trial design

2,000 participants in 2 patient groups

Patients with adverse anticoagulant outcomes

Description:

Patients with adverse anticoagulant outcomes in the study period. Adverse anticoagulant outcomes include venous thromboembolism recurrence, major bleeding, and clinical relevant non major bleeding.

Treatment:

Other: Data collection

Patients without any adverse anticoagulant outcomes

Description:

Patients without any adverse anticoagulant outcomes in the study period.

Treatment:

Other: Data collection