Lokale stolseloplossende behandeling bij een trombosebeen.

A randomized controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis combined with standard anticoagulant therapy, with standard anticoagulant therapy alone, in acute primary iliofemoral deep vein thrombosis.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21278

Enrollment

180

Registered

2010-07-07

Start date

2010-05-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

English key words: 'iliofemoral deep vein thrombosis'

Interventions

After randomization patients will be allocated to either conservative anticoagulant treatment alone or to catheter-directed thrombolysis combined with conservative anticoagulant treatment.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Objectively documented IFDVT; 2. Acute stage IFDVT, complaints less than 14 days; 3. Life expectancy longer than 6 months; 4. First thrombus in the affected limb.

Exclusion criteria

Exclusion criteria: 1. History of GI bleeding within 1 year; 2. History of CVA/CNS disease; 3. Severe hypertension (>180/100 mmHg); 4. Active malignancy; 5. Surgery within 6 weeks; 6. Previous thrombosis of the affected limb (secondary thrombosis); 7. Chronic venous insufficiency; 8. Pregnancy; 9. ALAT > 3 times normal range; 10. eGFR < 30.

Design outcomes

Primary

Measure	Time frame
1 year PTS incidence.	—

Secondary

Measure	Time frame
1. Clot lysis and patency; 2. Valve function; 3. Recurrent venous thrombo-embolism; 4. Late PTS; 5. Quality of life; 6. Medical costs.	—

Contacts

Public ContactStephanie Bukkems

PO Box 5800

cava@ah.unimaas.nl+31 (0)6 53129126

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)