Solid Cancer, Thrombosis
Conditions
Keywords
Thrombosis, Cancer, Heparin, Low Molecular Weight
Brief summary
During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date. Specifically focus will be on the following: * Number of thrombotic events * Anti-thrombotic management dosage & duration * Any bleedings related to anticoagulation * Patients' adherence and compliance
Interventions
DRUGLow Molecular Weight Heparin
Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH)
Sponsors
Metaxa Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery 2. Age ≥ 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 4. Life expectancy \>6 months 5. Signed informed consent
Exclusion criteria
1. Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery 2. Age \< 18 years 3. ECOG performance status \>2 4. Life expectancy \<6 months 5. Not signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of thrombotic events | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | Measure the number of thrombotic events in the population |
| Number of bleedings related to anticoagulation | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | Measure the number of observed bleeding events caused by the anticoagulation treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anticoagulation drug dosage | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | Record the antithrombotic drug dosage (IU/day), aiming to investigate the role of dosage for thrombotic events and bleedings (primary outcomes) |
| Anticoagulation drug duration | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | Record the antithrombotic drug duration (in days). The aim is to investigate the role of antithrombotic duration for thrombotic events and bleedings (primary outcomes) |
| Patients' compliance to anticoagulation treatment | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | Record the compliance of patients' in antithrombotic treatment. A patient is considered to be compliant if the anticoagulation treatment was administered as prescribed (usually every day), otherwise it is non-compliant. The aim is to investigate the role of patient compliance for thrombotic events and bleedings (primary outcomes). |
| Anticoagulation drug agent | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | Record the anticoagulation drug agent. The aim is to investigate the role of different agents for thrombotic events and bleedings (primary outcomes) |
Countries
Greece
Contacts
Primary ContactNikos Ziras, MD
Backup ContactSpyridon Xynogalos, MD
Outcome results
None listed