Venous ThromboembolismNCT03134820
Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease
An observational study of Venous Thromboembolism and Pulmonary Thromboembolisms, run by Delos 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Pulmonary Thromboembolisms, Cancer
- How many people
- 352 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2015to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients with life expectancy lower than 6 months
- Pregnancy woman
- Patients with cerebral metastasis
About this study
Official title: Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.
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.
Read the 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.
- Conditions
- Venous Thromboembolism, Pulmonary Thromboembolisms, Cancer
- Keywords
- Low molecular weight heparins, Procoagulants, Phospholipid-dependent Microparticles
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence thromboembolisms
Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
Measured: 3 months
Recurrence thromboembolisms
Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
Measured: 6 months
Secondary outcomes (2)
Hemorrhagic events
Hemorrhagic events due to LMWH treatment
Measured: 6 months
Thromboembolic event attributable death
Death related to embolic event
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start15 Dec 2015
- Primary completion31 Dec 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delos Clinical
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remedios Otero Candelera, Hospitales Universitarios Virgen del Rocío
- Investigators
- Remedios Otero Candelera, MD PhD, Study chair, Hospital Universitario Virgen del Rocío IBISTeresa Elias, MD PhD, Principal investigator, Hospitales Universitarios Virgen del RocíoIsabel Blasco, MD, Principal investigator, Hospital Universitario Virgen MacarenaMaria Rodriguez, MD, Principal investigator, Hospital Universitario de Valme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134820
- Sponsor's protocol ID
- Hispalis study
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.
- ClinicalTrials.gov ID
- NCT03134820
- Acronym / sponsor ID
- Hispalis study
- Conditions
- Venous Thromboembolism, Pulmonary Thromboembolisms, Cancer
- Keywords
- Low molecular weight heparins, Procoagulants, Phospholipid-dependent Microparticles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Delos ClinicalUniversity, hospital or other
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with life expectancy lower than 6 months
- Pregnancy woman
- Patients with cerebral metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Hemorrhagic events
Time frame: 6 months
Thromboembolic event attributable death
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remedios Otero Candelera, MD PhD study chair
Hospital Universitario Virgen del Rocío IBIS
Teresa Elias, MD PhD principal investigator
Hospitales Universitarios Virgen del Rocío
Isabel Blasco, MD principal investigator
Hospital Universitario Virgen Macarena
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Pulmonary Thromboembolisms, run by Delos Clinical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence thromboembolisms (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.