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

Recruiting

Conditions: 10014523
Cancer/malignancy
venous thomboembolism/blood cloth
10027656

Registration Number: NL-OMON49895

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 285

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

- 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 <30 mL/min (estimated using CKD-EPI equations)
- Solitary kidney (either functionally or anatomically)
- Allergy to contrast agents
- Anticipated referral to another hospital within a few days after PICC
placement

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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