Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

Cancer Clinical Trial

Official title:

Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134820
• Other study ID #: Hispalis study
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: April 26, 2017
• Start date: December 15, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Delos Clinical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: March 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pulmonary Embolism
• Pulmonary Thromboembolisms
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Delos Clinical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence thromboembolisms	Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression	3 months
Primary	Recurrence thromboembolisms	Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression	6 months
Secondary	Hemorrhagic events	Hemorrhagic events due to LMWH treatment	6 months
Secondary	Thromboembolic event attributable death	Death related to embolic event	6 months