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Trial record 27 of 56 for:    "Lung Disease" | "Dalteparin"

Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134820
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Remedios Otero Candelera, Hospitales Universitarios Virgen del Rocío

Tracking Information
First Submitted Date April 26, 2017
First Posted Date May 1, 2017
Last Update Posted Date May 1, 2017
Actual Study Start Date December 15, 2015
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2017)
  • Recurrence thromboembolisms [ Time Frame: 3 months ]
    Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
  • Recurrence thromboembolisms [ Time Frame: 6 months ]
    Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 26, 2017)
  • Hemorrhagic events [ Time Frame: 6 months ]
    Hemorrhagic events due to LMWH treatment
  • Thromboembolic event attributable death [ Time Frame: 6 months ]
    Death related to embolic event
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
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).
Condition
  • Venous Thromboembolism
  • Pulmonary Thromboembolisms
  • Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 26, 2017)
352
Original Actual Enrollment Same as current
Actual Study Completion Date March 31, 2017
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03134820
Other Study ID Numbers Hispalis study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Remedios Otero Candelera, Hospitales Universitarios Virgen del Rocío
Study Sponsor Delos Clinical
Collaborators Not Provided
Investigators
Study Chair: Remedios Otero Candelera, MD PhD Hospital Universitario Virgen del Rocío IBIS
Principal Investigator: Teresa Elias, MD PhD Hospitales Universitarios Virgen del Rocío
Principal Investigator: Isabel Blasco, MD Hospital Universitario Virgen Macarena
Principal Investigator: Maria Rodriguez, MD Hospital Universitario de Valme
PRS Account Delos Clinical
Verification Date April 2017