NCT06440044

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Thrombosis, Venous
• Colo-rectal Cancer
• Bleeding

Interventions

Type	Name	Description
OTHER	Data collection	A prospectively maintained database query of all patients with CRC and VTE was initially performed, and then each patient's electronic record was reviewed for inclusion criteria.

Timeline

• Start date: 2019-01-01
• Primary completion: 2024-06-16
• Completion: 2024-06-16
• First posted: 2024-06-03
• Last updated: 2024-07-15

Locations

1 site across 1 country: China