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

NCT05229471 | Unknown

• 1 other identifier: W19_237
• Study Type: observational
• Target: 220
• Locations: 3 countries
• Sites: 9

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

Outcome Measures

Primary Outcomes (2)

• Recurrent venous thromboembolism

  objectively confirmed recurrent VTE

  90 days

• Major bleeding

  Major bleeding per ISTH criteria

  90 days

Secondary Outcomes (1)

• Clinically relevant non-major bleeding

  90 days

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unselected adult cancer patients who develop symptomatic or incidental recurrent VTE while receiving appropriate doses of LMWH or DOACs for an acute VTE.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• G. d'Annunzio University: collaborator

Study Sites (9)

Gabriele D'Annunzio University

Chieti, Italy

RECRUITING

Meander Medisch Centrum

Amersfoort, Netherlands

RECRUITING

Amsterdam UMC, location AMC

Amsterdam, Netherlands

RECRUITING

Leids Universitair Merisch Centrum

Leiden, Netherlands

RECRUITING

Hospital Universitario Puerto Real

Cadiz, Spain

RECRUITING

hospital general universitario de Elche

Elche, Spain

RECRUITING

Clínica Universidad Navarra en Madrid

Madrid, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism; Recurrence

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Floris Bosch, Drs.

CONTACT

0031 20 5668791; f.t.bosch@amsterdamumc.nl

Marcello Di Nisio, Dr.

CONTACT

mdinisio@unich.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 8, 2022
• Study Start: June 2, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

ES (5); IT (1); NL (3)