Clinical trial NCT04248348: Metaxa Hospital THromboprophylaxis Program in Oncological & Surgical Patients
Official title: Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombosis
Solid Cancer
Keywords: Thrombosis
Cancer
Heparin, Low Molecular Weight
Lead sponsor: Metaxa Hospital
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid cancer patients

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of thrombotic events
timeFrame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
measure: Number of bleedings related to anticoagulation
timeFrame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Secondary outcomes:
measure: Anticoagulation drug dosage
timeFrame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
measure: Anticoagulation drug duration
timeFrame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
measure: Patients' compliance to anticoagulation treatment
timeFrame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
measure: Anticoagulation drug agent
timeFrame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Other outcomes:
Locations:
city: Piraeus
country: Greece
facility: Metaxa Hopital
state: Attica
Study officials:
affiliation: Metaxa Hospital
name: Nikos Ziras, MD
role: STUDY_CHAIR
affiliation: Metaxa Hospital
name: Spyridon Xynogalos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.