Prevención secundaria de TEV en pacientes con cáncer y trombosis venosa profunda de las extremidades superiores relacionada con catéter (STREAM-Line)
Prevención secundaria de la tromboembolia venosa en pacientes con cáncer y trombosis venosa profunda de las extremidades superiores relacionada con el catéter (estudio STREAM-Line)
This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tzu-Fei Wang, MD, MPH
- Número de teléfono: 73755 6137379988
- Correo electrónico: tzwang@toh.ca
Ubicaciones de estudio
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-
Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- Reclutamiento
- The Ottawa Hospital
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Contacto:
- Cecilia Germano
- Correo electrónico: cegermano@ohri.ca
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Sault Ste. Marie, Ontario, Canadá
- Reclutamiento
- Sault Area Hospital
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Contacto:
- Natalie Walde
- Correo electrónico: walden@sah.on.ca
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.
Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.
Able and willing to provide informed consent.
Exclusion Criteria:
Active bleeding or other reasons for which anticoagulation is contraindicated.
Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
Anticoagulation has been permanently stopped or reduced to prophylactic dose for > 5 days prior to enrollment for any reasons.
Pregnancy or breast feeding in patients who are prescribed a direct oral anticoagulant.
Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 and P-glycoprotein in patients who are prescribed a direct oral anticoagulant.
Cancer is in remission and CVC is removed prior to enrollment.
Requirement of dual antiplatelet therapies.
Platelet count < 50 x 109/L or creatinine clearance < 30 ml/min.
Life expectancy of less than 3 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Apixaban
2.5 mg twice daily |
Patients will be enrolled after at least 3 months of therapeutic anticoagulation for an acute catheter-related upper extremity DVT while they are treated with therapeutic anticoagulation as standard of care. After enrollment, patients will be managed with prophylactic dose of anticoagulation as long as either a CVC or active cancer is present. If cancer goes into remission, at the time of CVC removal, anticoagulation will be stopped, but patients will continue to be followed until the end of the study at 6 months.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Venous Thromboembolism (VTE) Rate
Periodo de tiempo: 6 months
|
The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months. |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Major Venous Thromboembolism (VTE) and Major bleeding Rate
Periodo de tiempo: 3 months
|
Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months. |
3 months
|
|
New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
Periodo de tiempo: 3 months and 6 months
|
New/recurrent symptomatic catheter-related upper extremity DVT. |
3 months and 6 months
|
|
New incidental Venous Thromboembolism (VTE)
Periodo de tiempo: 3 months and 6 months
|
New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans. |
3 months and 6 months
|
|
New Deep Vein Thrombosis (DVT)
Periodo de tiempo: 3 months and 6 months
|
New/recurrent any distal upper or lower extremity DVT or subsegmental PE. |
3 months and 6 months
|
|
Superficial vein thrombosis of upper or lower extremities
Periodo de tiempo: 3 months and 6 months
|
Superficial vein thrombosis of upper or lower extremities |
3 months and 6 months
|
|
New unusual site Venous Thromboembolism (VTE)
Periodo de tiempo: 3 months and 6 months
|
New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis). |
3 months and 6 months
|
|
Clinically Relevant Non-Major Bleeding (CRNMB) events
Periodo de tiempo: 3 months and 6 months
|
CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events. |
3 months and 6 months
|
|
Arterial thromboembolic events
Periodo de tiempo: 3 months and 6 months
|
Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism. |
3 months and 6 months
|
|
All-cause mortality
Periodo de tiempo: 3 months and 6 months
|
All-cause mortality |
3 months and 6 months
|
|
Correlative biomarkers
Periodo de tiempo: 6 months
|
Correlative biomarkers at 6 months, while the exact list of correlative biomarkers is to be determined at the time of study completion, examples include D-dimer, P-selectin, prothrombin F1+F2, thrombin generation, etc. |
6 months
|
|
Health-related quality of life using the EuroQoL-5D-5L Questionnaire
Periodo de tiempo: 6 months
|
Health-related quality of life using EuroQoL-5D-5L (5Dimension- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5L- severity levels) questionnaires on enrollment and at 6 months. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. |
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tzu-Fei Wang, MD, MPH, Ottawa Hospital Research Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Infecciones
- Embolia y Trombosis
- Tromboembolismo
- Trombosis venosa
- Trombosis
- Neoplasias
- Tromboembolismo venoso
- Infecciones relacionadas con el catéter
- Trombosis venosa profunda de las extremidades superiores
- Terapéutica
- Terapia puente
- apixaban
- Puente de anticoagulación
Otros números de identificación del estudio
- STREAM-Line
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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