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Ultrasound Accelerated Catheter-directed Thrombolysis in Primary Ilio-Femoral Deep Venous Thrombosis

2014-08-27 03:19:36 | BioPortfolio

Summary

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.

Objective: To assess whether catheter directed thrombolytic therapy for the treatment of IFDVT can safely and effectively reduce post thrombotic 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.

Study design: prospective, non blinded, randomized, controlled, multicenter, intervention study Study population: 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.

Intervention: After randomization patients will be allocated to either conservative anticoagulant treatment 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Primary Ilio-femoral Deep Venous Thrombosis

Intervention

Ekos endowave system thrombolysis

Location

Maastricht University Medical Centre
Maastricht
Limburg
Netherlands
6202 AZ

Status

Not yet recruiting

Source

Maastricht University Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:36-0400

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Medical and Biotech [MESH] Definitions

A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.

DEEP VEIN THROMBOSIS of an upper extremity vein (e.g., AXILLARY VEIN; SUBCLAVIAN VEIN; and JUGULAR VEINS). It is associated with mechanical factors (Upper Extremity Deep Vein Thrombosis, Primary) secondary to other anatomic factors (Upper Extremity Deep Vein Thrombosis, Secondary). Symptoms may include sudden onset of pain, warmth, redness, blueness, and swelling in the arm.

Disease involving the femoral nerve. The femoral nerve may be injured by ISCHEMIA (e.g., in association with DIABETIC NEUROPATHIES), nerve compression, trauma, COLLAGEN DISEASES, and other disease processes. Clinical features include MUSCLE WEAKNESS or PARALYSIS of hip flexion and knee extension, ATROPHY of the QUADRICEPS MUSCLE, reduced or absent patellar reflex, and impaired sensation over the anterior and medial thigh.

Growth of organisms using AUTOTROPHIC PROCESSES for obtaining nutrients and chemotrophic processes for obtaining a primary energy supply. Chemotrophic processes are involved in deriving a primary energy supply from exogenous chemical sources. Chemotrophic autotrophs (chemoautotrophs) generally use inorganic chemicals as energy sources and as such are called chemolithoautotrophs. Most chemoautotrophs live in hostile environments, such as deep sea vents. They are mostly BACTERIA and ARCHAEA, and are the primary producers for those ecosystems.

Hip deformity in which the femoral neck leans forward resulting in a decrease in the angle between femoral neck and its shaft. It may be congenital often syndromic, acquired, or developmental.

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