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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Molecular Weight Heparin | Drug | Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria
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Solid cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikos Ziras, MD | Contact | +306932748495 | zirasngr@otenet.gr | |
| Spyridon Xynogalos, MD | Contact | +306932056426 | sxyn@otenet.gr |
| Name | Affiliation | Role |
|---|---|---|
| Nikos Ziras, MD | Metaxa Hospital | Study Chair |
| Spyridon Xynogalos, MD | Metaxa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metaxa Hopital | Recruiting | Piraeus | Attica | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35552827 | Derived | Xynogalos S, Simeonidis D, Papageorgiou G, Pouliakis A, Charalambakis N, Lianos E, Mazlimoglou E, Liatsos AN, Kosmas C, Ziras N. Can thromboprophylaxis build a link for cancer patients undergoing surgical and/or chemotherapy treatment? The MeTHOS cohort study. Support Care Cancer. 2022 Aug;30(8):6973-6984. doi: 10.1007/s00520-022-07096-1. Epub 2022 May 12. |
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Data may be provided upon a reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2018 | Jan 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 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) |