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

Phase 1

• Conditions: Acute primary iliofemoral deep vein thrombosis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2014-005145-51-DE
• Lead Sponsor: Maastricht University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-18
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Patients aged between 18-65 years
Written informed consent prior to study participation
First thrombus in the affected limb
Objectively documented IFDVT on compression ultrasound.
Acute stage IFDVT, complaints less than 14 days
Life expectancy longer than 6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Previous thrombosis of the affected limb (secondary thrombosis)
Surgery within 2 weeks
Varicosities/venous insufficiency CEAP classification C3 or higher.
History of GI bleeding within 3 months
History of CVA/central nervous system disease within 12 months
Severe hypertension (>180/100 mmHg)
ALT > 3 times normal range
eGFR < 30 ml/min
Hypersensitivity to the active substance or to any of the excipients
Dual antiplatelettherapy
Dysfunction of thyroid gland
Decreased blood coagulation (haemorrhagic diathesis, concomitant therapy with anticoagulants, spontaneous fibrinolysis) and severe thrombocytopenia
Aneurysm and arteriovenous malformation
Acute pancreatitis, pericarditis, bacterial endocarditis, sepsis
Recent trauma including cardiopulmonary resuscitation, thoracic surgery or neurosurgery (e.g. within 2 months)
Increased risk of bleeding or previous severe bleeding event
known clinical hypersensitivity or prior reactions on contrast agents
history of asthma or other allergic troubles
Active malignancy
life expectancy < 6 month
Women, who are pregnant or without sufficient contraception or breastfeeding.
Alcohol or drug abuse
Employees of the investigator cooperation companies
Expected non-compliance
Patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
Participation on another clinical trial within the last 3 months
Subjects who are committed to an institution and/or penitentiary by judicial or official order
Immobility (Depending on wheelchair)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether catheter directed thrombolytic therapy for the treatment of IFDVT can safely and effectively reduce post thrombotic morbidity after one year.;Secondary Objective: The secondary objective is to study whether catheter directed thrombolytic intervention has a positive effect on the quality of life of patients with IFDVT and to assess late PTS.;Primary end point(s): Percentage of patients with PTS characterized by a Villalta-Prandoni score = 5 on two consecutive occasions of at least 3 months apart, or presence of a venous ulcer one year following the acute thrombotic event. (Villalta-Prandoni: score 5-9 = mild PTS, score 10-14 = moderate PTS, score = 15 or venous ulcer = severe PTS);Timepoint(s) of evaluation of this end point: Month 3, 6, 12, 24, 36, 48 after inclusion