Acute primary iliofemoral deep vein thrombosis
Conditions
Interventions
Trade Name: Urokinase HS medac
Product Name: Urokinase
Product Code: Urokinase
Pharmaceutical Form: Lyophilisate for solution for injection
Sponsors
Maastricht University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Health Related Quality of Life (HRQOL) based on scorings on SF-36, EuroQOL-5D, VEINES-QOL/Sym and pain disability index (3, 6 and 12 months after the event) Late PTS during follow-up Recurrent venous thrombo-embolisms (VTE): DVT (measured by Compression ultra sonography (CUS)) or pulmonary embolism (PE) during follow-up Clot lysis, patency (measured by MRA-Vasovist during baseline visit and after 12 months, which shows the occlusion percentage of all visualized veins). Measurements of markers of coagulation (INR, fibrinogen, aPTT) and inflammation (CRP, leucocytes) at the baseline visit, during treatment visit and 12 months after the event. Safety outcome: Bleeding events during anticoagulant therapy. ;Timepoint(s) of evaluation of this end point: Questionaires: baseline, month 3,6,12,24,36,48 Late PTS during follow-up: month 3,6,12,24,36,48 CUS/PE: Baseline Clot lysis, patency: baseline, after 12 months coagulation/inflamation markers: baseline, month 3,6,12,24,36,48 Bleeding events: baseline, month 3,6,12,24,36,48 | — |
Countries
Germany
Contacts
Public ContactMD, PhD, internal medicine & bioche
Maastricht University Medical Centre
Outcome results
None listed