|- candidate number||8218|
|- NTR Number||NTR2409|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jul-2010|
|- Secondary IDs||NCT00970619 Clinical trials.gov|
|- Public Title||Lokale stolseloplossende behandeling bij een trombosebeen.|
|- Scientific Title||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.|
|- ACRONYM||CAVA-trial (CAtheter Versus Anticoagulation)|
|- hypothesis||Ultrasound-accelerated catheter-directed thrombolysis can reduce the posttrombotic syndrome incidence, improve quality of life and reduce medical costs in patients with acute primary iliofemoral deep vein thrombosis.|
|- Healt Condition(s) or Problem(s) studied||Postthrombotic syndrome, Iliofemoral deep vein thrombosis|
|- 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||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;
9. ALAT > 3 times normal range;
10. eGFR < 30.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-mei-2010|
|- planned closingdate||17-mei-2012|
|- Target number of participants||180|
|- Interventions||After randomization patients will be allocated to either conservative anticoagulant treatment alone or to catheter-directed thrombolysis combined with conservative anticoagulant treatment.|
|- Primary outcome||1 year PTS incidence.|
|- Secondary outcome||1. Clot lysis and patency;|
2. Valve function;
3. Recurrent venous thrombo-embolism;
4. Late PTS;
5. Quality of life;
6. Medical costs.
|- Timepoints||0, 3, 6 and 12 months follow-up.|
|- Trial web site||www.cavatrial.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Stephanie Bukkems|
|- CONTACT for SCIENTIFIC QUERIES|| Stephanie Bukkems|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Iliofemoral deep venous thrombosis (IFDVT) is associated with significant postthrombotic morbidity. The presence of both obstruction and reflux significantly increases the chances for development of postthrombotic syndrome (PTS). Early thrombolysis may reduce the incidence of PTS as compared to treatment with conventional anticoagulant medication alone. Improvement of the health related quality of life (HRQOL) has been reported after surgical clot removal. The investigators hypothesize that such improvements could also be reached after catheter directed thrombolysis.
To assess whether catheter-directed thrombolytic therapy for the treatment of IFDVT can safely and effectively reduce postthrombotic morbidity after one year. 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.
Prospective, single blinded, randomized, controlled, multicenter, intervention study.
The study population includes all consecutive patients with IFDVT presenting at the emergency or outpatient departments of the participating centres. The thrombus should not be older than 14 days at randomization.
After randomization patients will be allocated to either conservative anticoagulant treatment alone or to catheter-directed thrombolysis combined with conservative anticoagulant treatment.
Main study parameters/endpoints:
The primary efficacy outcome is the incidence of PTS at one year; a decline in PTS incidence from 25% to 8% is anticipated. The secondary outcome is the Health related Quality of life and late PTS during follow-up. The principal safety outcome is major bleeding during anticoagulant therapy. Bleeding as well as events of recurrent thrombosis will be monitored. The patency of the venous system of the affected lower limb will be assessed as well as the percentage of clot lysis, after thrombolytic intervention. Additionally, measurements of markers of coagulation and inflammation will be performed during follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
For patients who are randomized to the intervention arm of the study a hospital stay for 24-36 hour is mandatory during catheter directed thrombolysis. All patients will undergo additional imaging by MRA-vasovist and air phletysmography (APG) at baseline and after 12 months. Clinical follow-up visits will be matching usual care at 3, 6, 12 months; blood will be taken at these visits. Health-related quality of life (HRQOL) questionnaires will be filled out by all patients at baseline, 3, 6 and 12 months after the event; and once a year during the entire study duration. Further treatment will be in accordance with current guidelines for antithrombotic treatment. There may be an enhanced risk of bleeding in the thrombolysis group. The expected benefit is reduction of PTS from 25% to 8%, together with an improved quality of life.
|- Main changes (audit trail)|
|- RECORD||7-jul-2010 - 27-jul-2010|