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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440044
• Other study ID #: 2024ZSLYEC-226
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: xiaoyan li
• Phone: 13609066172
• Email: lixyan5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment. Briefly, CRC patients with VTE treated with an anticoagulant (rivaroxaban or LMWH) for at least six months were identified. Patients diagnosed with PE and/or DVT via any radiologic imaging method, such as CT or ultrasound, were considered to have VTE. No formal predefined protocol or prospective screening plan for occult VTE was implemented. Both symptomatic individuals, diagnosed through symptom-prompted diagnostic imaging, and asymptomatic individuals, identified via imaging studies conducted for other medical purposes (e.g., cancer restaging), were included. VTE was considered cancer-related if the patient had a diagnosis of CRC within six months before or after the VTE diagnosis, any cancer treatment within the previous six months, or recurrent/metastatic cancer regardless of treatment.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bleeding
• Colo-rectal Cancer
• Colorectal Neoplasms
• Hemorrhage
• Major Bleed
• Recurrence
• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent VTE including deep vein thrombosis (DVT) and pulmonary embolism (PE)	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.	From the date of index VTE to VTE recurrence
Primary	Major Bleeding (MB)	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.	From the date of index VTE to MB occurrence
Primary	Clinical Relevant Non Major Bleeding (CRNMB)	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.	From the date of index VTE to CRNMB occurrence
Secondary	All cause mortality	Deaths, regardless of the mechanism, were included in the all-cause mortality outcome	One year follow up since index VTE identified