Clinical trial NCT03134820: Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease
Official title: Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Pulmonary Thromboembolisms
Cancer
Keywords: Low molecular weight heparins
Procoagulants
Phospholipid-dependent Microparticles
Lead sponsor: Delos Clinical
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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.

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

Primary outcomes:
measure: Recurrence thromboembolisms
timeFrame: 3 months
measure: Recurrence thromboembolisms
timeFrame: 6 months
Secondary outcomes:
measure: Hemorrhagic events
timeFrame: 6 months
measure: Thromboembolic event attributable death
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Virgen del Rocío IBIS
name: Remedios Otero Candelera, MD PhD
role: STUDY_CHAIR
affiliation: Hospitales Universitarios Virgen del Rocío
name: Teresa Elias, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen Macarena
name: Isabel Blasco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Valme
name: Maria Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: