DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. (NL28394)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00970619
First received: September 1, 2009
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Acute Thrombosis of Deep Veins of Proximal Lower Extremity
Device: Ekos endowave system thrombolysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Post thrombotic syndrome (percentage of patients with PTS) one year following the acute thrombotic event. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Health Related Quality of Life (HRQOL) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • PTS during follow-up [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Recurrent venous thrombo-embolisms (VTE): DVT/PE during follow-up [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Clot lysis, patency and valve function [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Measurements of markers of coagulation and inflammation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional anticoagulation therapy
Conservative treatment consists of an initial treatment with therapeutic doses of LMWH in combination with vitamin K-antagonists, followed by treatment with vitamin K-antagonist alone (after completing LMWH treatment of at least 5-7 days and after an INR above 2 has been reached on two consecutive measurements). Anticoagulant treatment will be installed according to national and international guidelines (ACCP 2008 [23], CBO 2008 [24]) tailored based on the character of the event (6 months of therapy for idiopathic DVT and 3 months for provoked DVT).
Device: Ekos endowave system thrombolysis
Catheter directed thrombolysis will be performed with an Ekos Endowave ® system (EKOS Corporation, Bothell, WA). The system uses a standard guide wire to position the Intelligent Drug Delivery Catheter across the length of the target clot. The guide wire is introduced through the popliteal vein. Along the guide wire the catheter is positioned. The location of the dispersion catheter is controlled and if necessary adjusted by X-ray. The guide wire is then pulled out and replaced with the Microsonic core (a miniscule high frequency (2MHz) ultrasound transducer). The system automatically monitors and controls the microsonic energy delivery. This system does not fragment the thrombus but only gives a structural change by which a better penetration of the thrombolytic agent is achieved.
Other Name: Ekos endowave ® system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 CVA/CNS disease
  • Severe hypertension (>180/100 mmHg)
  • Active malignancy
  • Surgery within 6 weeks
  • Previous thrombosis of the affected limb (secondary thrombosis)
  • Varicosities/venous insufficiency
  • Pregnancy
  • ALAT > 3 times normal range
  • eGFR < 30
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970619

Contacts
Contact: Rob Strijkers, MD +31615959307 rob.strijkers@gmail.com
Contact: Hugo ten Cate, MD, PhD +31433884262 h.ten.cate@mumc.nl

Locations
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Rob Strijkers, MD    +31615959307    cava@maastrichtuniversity.nl   
Contact: Arina ten Cate, MD, PhD    +31433871243    arina.tencate@maastrichtuniversity.nl   
Atrium MC Heerlen Recruiting
Heerlen, Netherlands
Contact: Jie, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Hugo ten Cate, MD, PhD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00970619     History of Changes
Other Study ID Numbers: MEC 09-2-093
Study First Received: September 1, 2009
Last Updated: October 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014