Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Venous Thromboembolism
- Sponsor
- Delos Clinical
- Enrollment
- 352
- Primary Endpoint
- Recurrence thromboembolisms
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH) during at least 3 months, but nowadays the duration of treatment is not accurately determined.
The D-Dimer determination has been used like recurrence predictors after LMWH treatment suspension, but in cancer patients the useful is limited. Phospholipid-dependent microparticles could been used like recurrence predictors in cancer patients and tailored the duration of LMWH treatment for each patient.
Detailed Description
We are carrying out a study in Cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn. Patients are being followed after LMWH withdrawal until 6 months. Blood samples are being taken at baseline (LMWH withdrawal), 3 weeks and 3 months after. We will look for association between several biomarkers and venous thromboembolism recurrences.
Investigators
Remedios Otero Candelera
MD Ph D
Hospitales Universitarios Virgen del Rocío
Eligibility Criteria
Inclusion Criteria
- •Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).
- •Patients treated with LMWH since cancer diagnostic.
- •Signed informed consent sheet
Exclusion Criteria
- •Patients with life expectancy lower than 6 months
- •Pregnancy woman
- •Patients with cerebral metastasis
Outcomes
Primary Outcomes
Recurrence thromboembolisms
Time Frame: 6 months
Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
Secondary Outcomes
- Hemorrhagic events(6 months)
- Thromboembolic event attributable death(6 months)