CT-venography compared to duplex ultrasound for detection of catheter-related thrombosis in cancer patients

CT-venography compared to duplex ultrasound for detection of catheter-related thrombosis in cancer patients - DETECT study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49895

Enrollment

285

Registered

2021-11-29

Start date

2022-04-19

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer/malignancy

Interventions

Ultrasound and CT-venography for catheter-related thrombosis screening.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 to 80 years - Diagnosis of solid or haematological cancer - Planned PICC placement for administration of systemic cancer therapy or other indications - Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: - Extremity DVT within 6 months prior to catheter insertion - Inserted central venous catheter within 12 hours prior to inclusion - Mechanical heart valve or pacemaker - Ongoing therapeutic anticoagulation - Known pregnancy - Creatinine clearance

Design outcomes

Primary

Measure	Time frame
The primary outcome is the composite of: 1. Screening-detected, clinically relevant, ipsilateral upper extremity deep-vein thrombosis at the discretion of the local radiologist, demonstrated by one of the following: - A non-compressible venous segment or abnormal flow on ultrasound; - An adjudicated vascular filling defect, detectable in at least 50% of the lumen around the catheter on CT-venography; - An adjudicated vascular filling defect in the non-cannulated deep veins on CT-venography. Upper extremity deep veins include the brachial, axillary, subclavian, brachiocephalic, jugular, and superior caval vein. 2. Screening-detected, clinically relevant pulmonary embolism at the discretion of the local radiologist, demonstrated by an intraluminal filling defect in a segmental or more proximal pulmonary artery on CT-venography.	—

Measure

Time frame

The primary outcome is the composite of: 1. Screening-detected, clinically relevant, ipsilateral upper extremity deep-vein thrombosis at the discretion of the local radiologist, demonstrated by one of the following: - A non-compressible venous segment or abnormal flow on ultrasound; - An adjudicated vascular filling defect, detectable in at least 50% of the lumen around the catheter on CT-venography; - An adjudicated vascular filling defect in the non-cannulated deep veins on CT-venography. Upper extremity deep veins include the brachial, axillary, subclavian, brachiocephalic, jugular, and superior caval vein. 2. Screening-detected, clinically relevant pulmonary embolism at the discretion of the local radiologist, demonstrated by an intraluminal filling defect in a segmental or more proximal pulmonary artery on CT-venography.

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Secondary

Measure	Time frame
Secondary endpoints include - Intrinsic pathway activation at baseline and during follow-up, assessed by levels of FXIIa:C1inh, FXIIa:AT, FXIa:C1inh, FXIa:AT, FXIa:a1AT, pKa:C1inh, and FIXa:AT complexes, and a factor XIa-dependent thrombin generation test. - Clinically relevant venous thromboembolism - Non-clinically relevant thrombi - Catheter malfunction - Major bleeding - Clinically relevant non-major bleeding - All-cause mortality - Allergic reaction to contrast agents - Reported contrast nephropathy - Initiation of anticoagulant therapy in patients with screening-detected upper-extremity deep-vein thrombosis and/or pulmonary embolism.	—

Measure

Time frame

Secondary endpoints include - Intrinsic pathway activation at baseline and during follow-up, assessed by levels of FXIIa:C1inh, FXIIa:AT, FXIa:C1inh, FXIa:AT, FXIa:a1AT, pKa:C1inh, and FIXa:AT complexes, and a factor XIa-dependent thrombin generation test. - Clinically relevant venous thromboembolism - Non-clinically relevant thrombi - Catheter malfunction - Major bleeding - Clinically relevant non-major bleeding - All-cause mortality - Allergic reaction to contrast agents - Reported contrast nephropathy - Initiation of anticoagulant therapy in patients with screening-detected upper-extremity deep-vein thrombosis and/or pulmonary embolism.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)