Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

Completed

• Conditions: Venous Thromboembolism; Pulmonary Thromboembolisms; Cancer

• Registration Number: NCT03134820
• Lead Sponsor: Delos Clinical

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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

Study Timeline

• Study Start: 2015-12-15
• Primary Completion: 2016-12-31
• Study Completion: 2017-03-31
• Status Verified: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence thromboembolisms	6 months	Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

Secondary Outcome Measures

Name	Time	Method
Thromboembolic event attributable death	6 months	Death related to embolic event
Hemorrhagic events	6 months	Hemorrhagic events due to LMWH treatment