Acute Thrombosis of Deep Veins of Proximal Lower Extremity Clinical Trial
— NL28394Official title:
Ultrasound Accelerated Catheter-directed Thrombolysis for Primary Iliofemoral Deep Vein Thrombosis (IFDVT) Compared to Non-invasive Conventional Anticoagulant Therapy Alone: a Dutch Randomized Controlled Multicenter Clinical Trial
| NCT number | NCT00970619 |
| Other study ID # | MEC 09-2-093 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 2010 |
| Est. completion date | November 2018 |
| Verified date | March 2020 |
| Source | Maastricht University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post
thrombotic morbidity. The presence of both obstruction and reflux significantly increases the
chances for development of post-thrombotic 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 (CDT).
Objective: To assess whether CDT for the treatment of IFDVT can safely and effectively reduce
post-thrombotic morbidity after one year. The secondary objective is to study whether CDT
intervention has a positive effect on the HRQOL of patients with IFDVT and to assess late
PTS.
Study design: Prospective, multicenter, single-blind, allocation concealed, randomized
controlled trial Study population: All consecutive patients with IFDVT presenting at the
emergency or outpatient departments of the participating centers. The thrombus should not be
older than 14 days at randomization.
Intervention: After randomization patients will be allocated to either conservative
anticoagulant treatment or to CDT combined with conservative anticoagulant treatment.
Main study parameters/endpoints: The primary efficacy outcome is the proportion 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. The principal safety outcome is major bleeding during
anticoagulant therapy. Bleeding as well as events of recurrent thrombosis will be monitored.
Measurements of markers of coagulation and inflammation will be performed during follow-up.
After CDT the patency of the venous system in the affected lower limb will be assessed as
well as the percentage of clot lysis. The development of late PTS during follow-up will also
be monitored.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: For patients who are randomized to CDT a hospital stay for 24-96 hours is
mandatory. All patients will undergo additional imaging by magnetic resonance venography and
air phletysmography (if available) at baseline and after 12 months; blood will be taken at
these visits. Clinical follow-up visits will be matching usual care at 3, 6, 12 months.
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.
| Status | Completed |
| Enrollment | 184 |
| Est. completion date | November 2018 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Objectively documented IFDVT - Acute stage IFDVT, complaints less than 14 days - Life expectancy longer than 6 months - First thrombus in the affected limb Exclusion Criteria: - History of GI bleeding within 1 year - History of cardiovascular accident /central nervous system disease within 1 year - Severe hypertension (>180/100 mmHg) - Active malignancy - Major surgery within 6 weeks - Previous thrombosis of the affected limb (secondary thrombosis) - Varicosities/venous insufficiency Clinical, Etiologic, Anatomic, and Pathophysiologic (CEAP) classification C3 or higher - Pregnancy - Immobility (wheelchair dependent) - Alanine aminotransferase (ALAT) > 3 times normal range - estimated Glomerular Filtration Rate (eGFR) < 30 mL/min |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | VuMC | Amsterdam | |
| Netherlands | Haga Ziekenhuis | Den Haag | |
| Netherlands | Nij Smellinghe | Drachten | |
| Netherlands | Catharina Ziekenhuis Eindhoven | Eindhoven | |
| Netherlands | MMC Eindhoven | Eindhoven | |
| Netherlands | St Anna Ziekenhuis | Geldrop | |
| Netherlands | Atrium MC Heerlen | Heerlen | |
| Netherlands | Elkerliek Ziekenhuis | Helmond | |
| Netherlands | Maastricht University Medical Centre | Maastricht | Limburg |
| Netherlands | St Antonius | Nieuwegein | |
| Netherlands | Laurentius Roermond | Roermond | |
| Netherlands | Maasstad ziekenhuis | Rotterdam | |
| Netherlands | VieCuri | Venlo | |
| Netherlands | Sint Jans Gasthuis | Weert | |
| Netherlands | Isala klinieken | Zwolle |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post thrombotic syndrome (percentage of patients with PTS) one year following the acute thrombotic event. | one year | ||
| Secondary | The Health Related Quality of Life (HRQOL) | 5 years | ||
| Secondary | PTS during follow-up | 5 years | ||
| Secondary | Recurrent venous thrombo-embolisms (VTE): DVT/Pulmonary Embolism during follow-up | 5 years | ||
| Secondary | Clot lysis, patency and valve function | 5 years | ||
| Secondary | Measurements of markers of coagulation and inflammation | 5 years |