Management of Recurrent Venous Thromboembolism During Anticoagulant Treatment in Cancer Patients - a Prospective Cohort Study

NCT ID: NCT05229471

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2024-12-31

Brief Summary

Objective: To prospectively evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis.

Study design: International, prospective, observational cohort study Study population: Adult cancer patients with symptomatic or incidental recurrent VTE while receiving LMWH or DOACs for acute VTE are eligible. Main exclusion criteria include anticoagulant treatment for the recurrent VTE for more than 72 hours, severe hepatic dysfunction, active bleeding, recent major surgery, uncontrolled hypertension, known bleeding diathesis, and a life expectancy of less than 1 month.

Study procedures: Patients will be managed at the discretion of the treating physician, who will be encouraged to follow guideline recommendations. These guidelines suggest supra-therapeutic dose LMWH for 4 weeks (+/- 5 days) followed by therapeutic dose LMWH or therapeutic dose DOAC, while it is suggested to treat patients with VTE recurrence during maintenance dose LMWH (i.e. 75 to 80% of full therapeutic weight adjusted dose) with therapeutic dose of LMWH or DOAC.

Main study parameters/endpoints: The co-primary outcomes are new symptomatic or incidental recurrent VTE during 3 months of follow-up and on-treatment major bleeding. Secondary outcomes include recurrent incidental VTE, recurrent symptomatic VTE, recurrent incidental or symptomatic proximal or distal DVT, recurrent incidental or symptomatic PE, clinically relevant non-major bleeding, all-cause mortality, and cancer-related mortality. VTE occurring at other sites such as cerebral DVT or splanchnic DVT will also be recorded.

Conditions

Cancer; Venous Thromboembolism; Recurrence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Documented active cancer (i.e. diagnosis of cancer within the past 6 months; recurrent, regionally advanced, or metastatic disease; currently receiving treatment or received treatment within the past 6 months)
• Objectively confirmed symptomatic or incidental recurrent VTE while on anticoagulant therapy. The previous VTE and index recurrent VTE will include symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower extremities; symptomatic proximal upper extremity DVT (either related to a catheter or not); symptomatic distal DVT; symptomatic or incidentally detected multiple subsegmental, segmental or more proximal pulmonary embolism (PE).

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Use of thrombolysis
• Anticoagulant treatment for the recurrent VTE for longer than 72 hours
• Treatment with fondaparinux, unfractionated heparin, prophylactic doses of LMWH, or VKAs at time of recurrent VTE
• Acute hepatitis, chronic active hepatitis, or severe hepatic dysfunction (Child Pugh C or <MELD > 10)
• Active bleeding
• Recent major surgery (<2 weeks or longer, if still at high risk for bleeding)
• Uncontrolled hypertension (systolic arterial pressure >160 mmHg)
• Known bleeding diathesis
• Platelet count <50.000 mm3
• Creatinine clearance <30 mL/min (Cockcroft-Gault formula)
• Life expectancy of less than 1 month
• Dual antiplatelet therapy or aspirin at doses ≥165 mg daily
• Current diagnosis or history of heparin-induced thrombocytopenia
• Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study.
• Suspected non-compliance at the time of recurrent VTE

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Harry R. Buller

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele D'Annunzio University

Chieti, , Italy

Site Status: RECRUITING

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status: RECRUITING

Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Leids Universitair Merisch Centrum

Leiden, , Netherlands

Site Status: RECRUITING

Hospital Universitario Puerto Real

Cadiz, , Spain

Site Status: RECRUITING

hospital general universitario de Elche

Elche, , Spain

Site Status: RECRUITING

Clínica Universidad Navarra en Madrid

Madrid, , Spain

Site Status: RECRUITING

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status: RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status: RECRUITING

Countries

Italy; Netherlands; Spain

Central Contacts

Floris Bosch, Drs.

Role: CONTACT

f.t.bosch@amsterdamumc.nl

0031 20 5668791

Marcello Di Nisio, Dr.

Role: CONTACT

mdinisio@unich.it

Facility Contacts

Marcello Di Nisio

Role: primary

Hans-Martin Otten

Role: primary

Floris Bosch

Role: primary

Erik Klok, Dr.

Role: primary

Juan Bosco López-Saez

Role: primary

Francisco J. Pelegrín Mateo

Role: primary

Pedro Ruiz-Artacho

Role: primary

Sofia Huerga Domínguez

Role: primary

Luis Jara-Palomares

Role: primary

Other Identifiers

W19_237

Identifier Type: -

Identifier Source: org_study_id