Metaxa Hospital THromboprophylaxis Program in Oncological & Surgical Patients

Study Overview
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Brief Summary
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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

Official Title
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Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients

Conditions
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Thrombosis, Solid Cancer

Intervention / Treatment
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* Drug: Low Molecular Weight Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy >6 months Signed informed consent Exclusion Criteria Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery Age < 18 years ECOG performance status >2 Life expectancy <6 months Not signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Low Molecular Weight Heparin|Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of thrombotic events | Measure the number of thrombotic events in the population | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | 
| Number of bleedings related to anticoagulation | Measure the number of observed bleeding events caused by the anticoagulation treatment | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticoagulation drug dosage | Record the antithrombotic drug dosage (IU/day), aiming to investigate the role of dosage for thrombotic events and bleedings (primary outcomes) | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | 
| Anticoagulation drug duration | Record the antithrombotic drug duration (in days). The aim is to investigate the role of antithrombotic duration for thrombotic events and bleedings (primary outcomes) | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | 
| Patients' compliance to anticoagulation treatment | 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). | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | 
| Anticoagulation drug agent | Record the anticoagulation drug agent. The aim is to investigate the role of different agents for thrombotic events and bleedings (primary outcomes) | Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombosis, Cancer, Heparin, Low Molecular Weight