A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis combined with standard anticoagulant therapy versus standard anticoagulant therapy alone for acute primary iliofemoral deep vein thrombosis (IFDVT).

Phase 3

Completed

• Conditions: thrombosis; 10003184; 10003216

• Registration Number: NL-OMON45108
• Lead Sponsor: academisch ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-12-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 184

Inclusion Criteria

Age between 18-85 yrs, objectively documented IFDVT at least no patency in the common femoral vein, acute stage ( 6 months, first thrombus in the affected leg,

Exclusion Criteria

History of GI bleeding within 12 months, History of CVA/CNS disease whitin 12 months, Severe hypertension ( >180/100 mmHg), Active malignancy, Major surgery within 6 weeks, Previous thrombosis of the affected limb, Varicositas/venous insufficiency, (CEAP classification C3 or higher) Pregnancy, ALAT > 3 times normal range, GFR < 30 mL/min ,
permanent wheelchair dependency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients with PTS charactarized by a Villalta-Prandoni score * 5<br /><br>on two consecutive occasions of at least 3 months apart, or presence of a<br /><br>venous ulcer one year following the acute thrombotic event. (Villalta-Prandoni:<br /><br>score 5-9 = mild PTS, score 10-14 = moderate PTS, score * 15 or venous ulcer =<br /><br>severe PTS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The Health Related Quality of Life (HRQOL) based on scorings on SF-36,<br /><br>EuroQOL-5D, pain disability index and VEINES-QOL/Sym (t3,6,12 months after the<br /><br>event)<br /><br>* Late PTS during follow-up<br /><br>* Recurrent venous thrombo-embolisms (VTE): DVT (measured by CUS) or pulmonary<br /><br>embolism (PE) (objectivated by spiral CT-angiography) during follow-up<br /><br>* Clot lysis, patency (measured by duplex ultrasound and MRA-gadofosveset<br /><br>trisodium(Vasovist or ablavar) at t0 and 12 months, which shows the percentage<br /><br>of occlusion of all visualized veins) and valve function (measured by APG<br /><br>imaging at t0 and 12 months)<br /><br>* Measurements of markers of coagulation and inflammation (at t0 and 12 months)</p><br>