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

Completed

• Conditions: Bleeding; Thrombosis, Venous; Colo-rectal Cancer
• Interventions: Other: Data collection

• Registration Number: NCT06440044
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Primary Completion: 2024-06-16
• Study Completion: 2024-06-16
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with adverse anticoagulant outcomes	Data collection	Patients with adverse anticoagulant outcomes in the study period. Adverse anticoagulant outcomes include venous thromboembolism recurrence, major bleeding, and clinical relevant non major bleeding.
Patients without any adverse anticoagulant outcomes	Data collection	Patients without any adverse anticoagulant outcomes in the study period.

Primary Outcome Measures

Name	Time	Method
Major Bleeding (MB)	From the date of index VTE to MB occurrence, assessed up to 12 months	MB was defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL after the incident, requirement for transfusion of ≥ 2 units of packed read blood cells, or intracranial, intraspinal, intraocular, pericardial, retroperitoneal, intramuscular causing compartment syndrome, or fatal bleeding.
Clinical Relevant Non Major Bleeding (CRNMB)	From the date of index VTE to CRNMB occurrence, assessed up to 12 months	CRNMB was defined as overt bleeding not meeting the criteria for MB but associated with medical intervention, unscheduled contact with a member of the health care team, temporary cessation of the treatment, or impairment of activities of daily life.
recurrent VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE)	From the date of index VTE to VTE recurrence, assessed up to 12 months	Recurrent DVT had to be confirmed by duplex ultrasonography, venography, CT, or MRI. Recurrent PE was confirmed by CT, MRI, conventional pulmonary angiography, or VQ (ventilation/perfusion) imaging. Fatal PE had to be based on objective diagnostic testing, autopsy, or death that could not be attributed to a documented cause and for which PE/DVT could not be ruled out (unexplained death). Incidental VTE recurrence had to be identified via surveillance-related imaging. To be classified as a recurrent event, a new filling defect had to be evident on the second study, not appreciated on the original images, or an interval study clearly showing thrombus resolution.

Secondary Outcome Measures

Name	Time	Method
All cause mortality	One year follow up since index VTE identified until the date of death from any cause, whichever came first, , assessed up to 12 months	Deaths, regardless of the mechanism, were included in the all-cause mortality outcome

Trial Locations

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China