Metaxa Hospital THromboprophylaxis Program in Oncological & Surgical Patients

• Conditions: Solid Cancer; Thrombosis

• Registration Number: NCT04248348
• Lead Sponsor: Metaxa Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

Metaxa Hopital; 🇬🇷 Piraeus, Attica, Greece