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

Phase 3
Completed
Conditions
Acute Thrombosis of Deep Veins of Proximal Lower Extremity
Registration Number
NCT00970619
Lead Sponsor
Maastricht University Medical Center
Brief 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 (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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
184
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Post thrombotic syndrome (percentage of patients with PTS) one year following the acute thrombotic event.one year
Secondary Outcome Measures
NameTimeMethod
The Health Related Quality of Life (HRQOL)5 years
Recurrent venous thrombo-embolisms (VTE): DVT/Pulmonary Embolism during follow-up5 years
PTS during follow-up5 years
Measurements of markers of coagulation and inflammation5 years
Clot lysis, patency and valve function5 years

Trial Locations

Locations (16)

Maastricht University Medical Centre

🇳🇱

Maastricht, Limburg, 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

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Maastricht University Medical Centre
🇳🇱Maastricht, Limburg, Netherlands

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